Clinical trial NCT03875274
Conditions: Postoperative Pain
Sponsor: B.P. Koirala Institute of Health Sciences
Start date: 2017-04-01; Completion date: 2017-12-31
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
prospective, randomized double blinded study to investigate the effects of morphine as an adjuvant to ropivacaine on FICB

Detailed description:

Arms: arm 1: Ropivacaine 0.375% 20 ml + Normal saline 2 ml via FICB arm 2: Ropivacaine 0.375% 20 ml + Morphine 2 ml via FICB
Interventions: intervention 1: Ropivacaine, Morphine intervention 2: Ropivacaine, Saline
Intervention descriptions: intervention 1: Morphine added to ropivacaine for fascia iliaca compartment block intervention 2: Normal saline added to ropivacaine for fascia iliaca compartment block

Protocol documents:
Prot_SAP_ICF_000.pdf: 
Title: Postoperative Analgesic Effect of Morphine added to Ropivacaine for Fascia 
Iliaca Compartment Block Following Femoral Fracture Surgeries 
Author: Pankaj Baral 
Co authors: Ashish Ghimire, Birendra Prasad Sah, Balkrishna Bhattarai, Sindhu 
Khatiwada, Jagat Narayan Prasad 
Date: 1st June, 2016  
NCT No. 03875274 
 
 


 
 
 
POSTOPERATIVE ANALGESIC EFFECT OF MORPHINE ADDED TO 
ROPIVACAINE FOR FASCIA ILIACA COMPARTMENT BLOCK FOLLOWING 
FEMORAL FRACTURE SURGERIES 
 
 
 
 
 
PROTOCOL SUBMITTED FOR MD IN ANAESTHESIOLOGY AND CRITICAL 
CARE  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE 
B.P. KOIRALA INSTITUTE OF HEALTH SCIENCES 
 
DHARAN, NEPAL 
 
 
 
 
 
 
 
 
DR PANKAJ BARAL 
1st JUNE 2016 
 
 


POSTOPERATIVE ANALGESIC EFFECT OF MORPHINE ADDED TO 
ROPIVACAINE FOR FASCIA ILIACA COMPARTMENT BLOCK FOLLOWING 
FEMORAL FRACTURE SURGERIES 
 
PROTOCOL OF THESIS SUBMTTED TO B.P. KOIRALA INSTITUTE OF 
HEALTH SCIENCES TOWARDS PARTIAL FULFILMENT OF THE 
REQUIREMENT OF THE DEGREE OF 
MD IN ANAESTHESIOLOGY AND CRITICAL CARE  
 
January 2016 
 
CANDIDATE 
 
…………………………. 
Dr. Pankaj Baral 
Junior Resident 
Department of Anaesthesiology and 
Critical Care 
BPKIHS, Dharan 
pankajbaral7@gmail.com 
GUIDE 
 
…………………………. 
Dr. Ashish Ghimire 
Additional Professor 
Department of Anaesthesiology and 
Critical Care 
BPKIHS, Dharan 
ashishghimi@hotmail.com
 
CO-GUIDES 
…………………………. 
Dr. Birendra Prasad Sah 
Professor, 
Department of Anaesthesiology and 
Critical Care 
BPKIHS, Dharan 
 
 
…………………………. 
Dr. Krishna Pokharel 
Additional Professor 
Department of Anaesthesiology and 
Critical Care 
BPKIHS, Dharan 
…………………………. 
Dr. Sindhu Khatiwada 
Additional Professor 
Department of Anaesthesiology and 
Critical Care 
BPKIHS, Dharan 
 
 
…………………………. 
Dr. Jagat Narayan Prasad 
Associate Professor 
Department of Anaesthesiology and 
Critical Care 
BPKIHS, Dharan 
 
HEAD OF DEPARTMENT 
 
…………………………………… 
Dr. Birendra Prasad Sah  
Professor 
Department of Anaesthesiology and Critical Care 
BPKIHS, Dharan


A 
 
SUMMARY OF POST GRADUATE THESIS PROTOCOL 
1. Study title: Postoperative analgesic effect of morphine added to ropivacaine for 
fascia iliaca compartment block following femoral fracture surgeries 
2. Name of the student: Dr. Pankaj Baral 
3. Department: Department of Anaesthesiology and Critical Care Medicine 
4. Name of Chief Guide: Dr. Ashish Ghimire 
5. Name of Co-guide/s & Department/s:  
 
Dr. Birendra Prasad Sah 
 
Professor,  
 
Department of Anaesthesiology and Critical Care 
Dr. Krishna Pokharel 
 
Additional Professor,  
 
Department of Anaesthesiology and Critical Care 
Dr. Sindhu Khatiwada 
 
Additional Professor,  
 
Department of Anaesthesiology and Critical Care 
Dr. Jagat Narayan Prasad 
 
Assistant Professor,  
 
Department of Anaesthesiology and Critical Care 
6. Email ID of the candidate & Chief Guide:  
pankajbaral7@gmail.com 
ashishghimi@hotmail.com 
7. Rationale of the research: Femoral fracture are common and require open 
reduction and internal fixation for treatment. A substantial complaint of pain 


B 
 
experienced in the patients after this surgery is derived from the incision. Earlier 
and improved rehabilitation occurs when peripheral nerve blocks are used to 
provide post-operative analgesia. A sufficient volume of local anaesthetic 
deposited beneath the fascia iliaca provides effective postoperative analgesia and 
decreases the rescue opioid analgesics requirement during the post-operative 
period. FICB blocks the femoral, lateral cutaneous and obturator nerves, that are 
responsible for transmission of pain impulses from the incision.  Opioids have been 
used as adjunct drugs in peripheral nerve blocks (Saryazdi et al. 2015). The 
reports on addition of opioids to local anaesthetics in FICB for prolongation of 
postoperative analgesia are limited. 
Rationale of the current study is to use morphine as an adjunct to ropivacaine for 
USG guided FICB for post-operative analgesia in patients undergoing femoral 
fracture surgeries. 
8. Primary & Secondary Objectives: Enclosed 
9. Research Hypothesis (Null Hypothesis):  
Morphine added to ropivacaine in ultrasound guided fascia iliaca compartment 
block does not prolong the duration of analgesia and minimize the requirement of 
postoperative rescue analgesics following femoral fracture surgeries. 
10. Material & Methods: Enclosed 
a. Whether study involves Human/animals or both: Human 
b. Population/ participants:  
a. Group A - Ropivacaine 0.375% 20 ml with NS 2 ml for FICB 
b. Group B - Ropivacaine 0.375% 20 ml with morphine (1mg/ml) 2 ml for 


C 
 
FICB 
c. Type of study design: Prospective Randomised Double Blind Clinical Study 
d. Setting: Department of Anaesthesia and Critical Care, BPKIHS 
e. Sample Selection criteria:  
a. Inclusion Criteria: Enclosed 
b. Exclusion Criteria: Enclosed 
f. Expected sample size: 70 
g. Probable duration of study: 1 year 
h. Parameter/Variables to be measured: As per proforma 
i. Outcome measures: Duration of analgesia, requirement of rescue analgesics, 
numeric rating scale (NRS) for pain, sedation score. 
j. Statistical methods to be employed: Enclosed 
k. Ethical clearance: Will be obtained from the Institutional Review Committee 
l. Permission to use copyright questionnaire/ 
Proforma: Enclosed 
12. Maintain the confidentiality of subject: Yes 
13. References: Attached 
14. Whether available resources are adequate: Adequate 
15. Other resources needed: No 
16. ANNEXURES  
a. Participants record form (clinical data sheet)  
b. Participant Information sheet  
i. Attached English  


D 
 
ii. Attached Nepali  
c. Participant Informed consent form  
ii. Attached English  
iii. Attached Nepali 
 
 


E 
 
 
Contents 
INTRODUCTION ........................................................................................................................................ 1 
REVIEW OF LITERATURE ...................................................................................................................... 5 
OBJECTIVES .............................................................................................................................................. 9 
RESEARCH HYPOTHESIS ................................................................................................................... 10 
MATERIAL AND METHODS .................................................................................................................. 10 
REFERENCES ......................................................................................................................................... 18 
ANNEXURES ............................................................................................................................................ 22 
PARTICIPANT RECORD FORM ....................................................................................................... 22 
PARTICIPANT INFORMATION SHEET ........................................................................................... 24 
जानकारी पर्ा ............................................................................................................................................ 26 
PARTICIPANT INFORMED CONSENT FORM .............................................................................. 28 
मन्जुरीनामा पत्र ......................................................................................................................................... 29 
 
 
 


1 
 
INTRODUCTION  
Pain is not just a sensory modality but an experience. The International Association for 
the Study of Pain (IASP) defines pain as “an unpleasant sensory and emotional 
experience associated with actual or potential tissue damage, or described in terms of 
such damage.” This definition recognizes the interplay between the objective, 
physiological sensory aspects of pain and its subjective, emotional, and psychological 
components. The response to pain can be highly variable among different individuals as 
well as in the same person at different times. (John F. Butterworth IV, David C. Mackey 
2013) 
With their knowledge of and familiarity with pharmacology, various regional anaesthesia 
techniques, and the neurobiology of nociception, anaesthesiologists are prominently 
associated with the clinical and research advances in acute postoperative pain 
management. Anaesthesiologists developed the concept of acute postoperative pain 
services (inpatient pain services), application of evidence based practice to acute 
postoperative pain, and creation of innovative approaches to acute pain medicine, all of 
which are a natural part of the anaesthesiologist’s functions as a “perioperative 
physician,” consultant, and therapist throughout an institution, as well as a highly skilled 
expert in the operating room.(Miller 2015)  
The stress hormones released in pain causes increase in heart rate, respiratory rate, 
myocardial oxygen demand, hypertension, arrhythmias and may lead to myocardial 
ischaemia (Biebuyk 1990). All these factors bear adverse prognosis in post-operative 
recovery and increase in morbidity and post-operative hospital stay.  


2 
 
Patients with a femur fracture have a relatively high risk of perioperative morbidity and 
mortality, related to their age and co-morbidities (Maxwell et al. 2013). Clinicians are 
frequently reluctant to administer adequate parenteral analgesia to these patients, for fear 
of worsening inter-current disease or of precipitating unwanted side effects in patients 
who are often already frail.(Finlayson & Underhill 1988). 
 Analgesic techniques should aim to provide optimal pain relief whilst minimizing side 
effects such as sedation, post-operative nausea and vomiting (PONV), hypotension, and 
motor block. Current evidence supports earlier and improved rehabilitation when 
peripheral nerve blocks are used to provide post-operative analgesia. They can provide 
excellent analgesia with minimal motor block. This facilitates early and more effective joint 
mobilization and physiotherapy, while limiting reﬂex muscle spasm. In addition, they avoid 
the systemic side effects associated with continuous epidural analgesia (hypotension, 
urinary retention) and PCA morphine (sedation, PONV).(Grant & Checketts 2008) 
The fascia iliaca compartment block is a simple, inexpensive, and effective method of 
prehospital analgesia for femoral shaft fracture. (Lopez et al. 2003) 
Three major nerves (femoral, lateral cutaneous and obturator) of the lumbar plexus are 
blocked in FICB, first described by Dalens et al. The FICB has traditionally been 
undertaken by loss of resistance using palpable anatomical landmarks. Using this 
landmark approach, complete nerve block in the distribution of the lumbar plexus may be 
achieved only in 38% of cases. Ultrasound guided regional techniques offer a number of 
advantages including real time needle guidance and direct observation of local 
anaesthetic spread within tissue planes.(Williams et al. 2008) 


3 
 
The mechanism behind the FICB is that the femoral and lateral femoral cutaneous nerves 
lie under the iliacus fascia. Therefore, a sufficient volume of local anaesthetic deposited 
beneath the fascia iliaca, even if placed some distance from the nerves, has the potential 
to spread underneath the fascia and reach these nerves. The ultrasound-guided 
technique is essentially the same; however, monitoring of the needle placement and local 
anaesthetic delivery assures deposition of the local anaesthetic into the correct plane. 
Ropivacaine, a local anaesthetic agent, is an enantiomer of bupivacaine with less cardiac 
and neurotoxic effects. It produces intense analgesia with less motor blockade compared 
to bupivacaine which is preferable in these patients for early mobilization.(Ganesan et al. 
2011)  
As compared with racemic bupivacaine, ropivacaine also has clinically relevant 
advantage of a stronger differentiation between sensory and motor blocks, which is 
particularly useful when early mobilization is important to accelerate postoperative 
recovery. Ropivacaine is 40-50% less potent than bupivacaine and levobupivacaine 
because of its lower lipid solubility; however, a reduced potency does not imply that this 
agent is less effective than the other two, and using an equipotency ratio of 1.5 : 1 
between ropivacaine and the two other drugs results in a substantially similar clinical 
profile with a good preservation of motor function.(Leone et al. 2008) 
Various adjuncts like epinephrine, dexamethasone, clonidine, fentanyl, morphine, 
dexmedetomidine etc. have been studied to improve the quality of peripheral regional 
local anaesthetic block with varying success. 


4 
 
Systemic opioids are being used as analgesics after surgery for many years. Pain 
reduction of opioids through central receptors and spinal cord is well‑known. The 
peripheral effects of opioids and their mechanism of action have been studied recently, 
and they have been used as an adjunct drug in peripheral nerve blocks.(Saryazdi et al. 
2015) 
Morphine is routinely administered by intramuscular, intrathecal, or epidural routes for the 
relief of pain. It is thought to produce its effects by an action on specific receptors in the 
dorsal horn of the spinal cord and on central opioid receptors. Reports have suggested 
that morphine injected perineurally in patients with chronic pain may also have a clinicalIy 
significant effect and that its duration of action may be longer than that of systemically 
administered morphine or bupivacaine (Racz et al. 1991). 
Till date, addition of morphine to ropivacaine for fascia iliaca compartment block has not 
been conducted in our setup and patients. Purpose of the current study is to use morphine 
as an adjunct to ropivacaine for USG guided FICB for post-operative analgesia in patients 
undergoing femoral fracture surgeries and assess the duration and quality of pain control 
and the requirement of rescue analgesics. 
 
 
 


5 
 
REVIEW OF LITERATURE  
Morrison et al. studied the impact of postoperative pain on outcomes following hip 
fractures. They found that post-operative pain was associated with increased hospital 
length of stay, delayed ambulation, and long-term functional impairment. Improved pain 
control might decrease length of stay, enhance functional recovery, and improve long-
term functional outcomes. 
Wambold et al. and his team reported that fascia iliaca nerve block provides excellent 
post-operative pain relief after knee surgery and it is easy to perform, safe and effective. 
Lopez et al. reported that fascia iliaca compartment block was simple, inexpensive and 
effective method of prehospital analgesia for femoral shaft fracture. It provided faster and 
more consistent simultaneous blockade of lateral cutaneous and femoral nerve than 3-in-
1 block. A sensory block of the inner part of thigh could be used as early predictive sign 
of optimal pain relief. 
Based on prospective, randomized, double blind study, Cuignet O et al  reported that 
single shot fascia iliaca block is an easy, inexpensive and efficient method for diminishing 
pain during post-operative period in burn patients undergoing skin-grafting. A single block 
had the same morphine sparing-effect as the continuous technique. Patients receiving a 
single block experienced less residual paresia and were more satisfied with their pain-
relief treatment than those who received a continuous infusion.  
Stevens et al. reported that a modified fascia iliaca compartment block with 30 ml 0.5% 
bupivacaine with 1:200,000 adrenaline, 150 microgram clonidine and 9 ml 0.9% saline 
has a significant morphine-sparing effect in unilateral total hip arthroplasty. 


6 
 
Williams et al.  compared ultrasound guided fascia iliaca compartment block with loss of 
resistance technique in 80 patients undergoing either unilateral hip or knee joint 
replacement surgery. They found that ultrasound-guided fascia iliaca block increased the 
frequency of sensory loss in the medial aspect of the thigh and also increased the 
frequency of femoral and obturator motor block. 
In a study done by Ganesan et al., they reported that administration of ropivacaine 0.5% 
as fascia iliaca compartment block, for postoperative analgesia in lower limb orthopaedic 
surgeries, was very effective in providing considerable pain relief in majority of the 
patients in the first 4-6 hrs. Also it was simple to perform without serious adverse effects. 
Öster Svedberg et al.  studied the compatibility of different opioids (morphine, sufentanil 
and fentanyl) with ropivacaine. They found that all combinations at all doses stayed within 
the compatibility criteria. In addition, there were no important differences in the 
enantiomeric purity of ropivacaine with each combination. 
In a prospective, randomized, double blind clinical trial study, Saryazdi et al. compared 
the effects of addition of different opiates (morphine, meperidine, buprenorphine, or 
fentanyl) to lidocaine in duration and quality of axillary brachial plexus block. They found 
that addition of morphine or pethidine to lidocaine was superior to other opioids (i.e. 
fentanyl and buprenorphine) due to better quality and quantity of motor blockade and 
faster onset of the block. 
In a double-blind, randomised controlled cross-over study Dahl.  compared the effects of 
perineuronal injections of morphine with epidural injections with the same amount of 


7 
 
morphine in patients after knee surgery. They found that better pain scores were achieved 
during treatment with epidural morphine. 
Kardash et al. added fentanyl to mepivacaine for supraclavicular brachial plexus block. 
They found that there was no statistically significant difference in sensory or motor block 
characteristics by addition of fentanyl. There was a significantly lower VAS score among 
the patients with fentanyl added to their blocks within the first hour after the operation but 
subsequent VAS scores and total 24-hour patient-controlled analgesia requirements were 
no different. 
Gessel & Donald. found that the addition of morphine 5 mg to interscalene brachial 
plexus block does not improve the quality of intraoperative analgesia, prolong the effect 
of the block or decrease the requirements for analgesia in the first 48 h after operation. 
Bourke & Furman. failed to detect a difference in postoperative visual analog scores, 
motor or sensory block duration with perineural morphine when added to axillary blocks 
performed with lidocaine plus epinephrine when compared to intravenous (IV) morphine 
supplementation. However, they did report a significantly decreased consumption of 
supplemental opioid doses. 
Bazin et al. demonstrated that the addition of opioids to a mixture of bupivacaine and 
lignocaine in brachial plexus block doubles the duration of postoperative pain relief. It 
prolonged the median duration of analgesia after internal fixation of upper extremity 
fractures from 11.5 to 21 hours. 
Sternlo & Hägerdal. found that addition of morphine to 0.5% bupivacaine was not 
associated with prolongation of intercostal nerve block. 


8 
 
Racz et al. showed that analgesia duration with intramuscular (IM) morphine was 
indistinguishable from morphine mixed with local anaesthetic after hand and forearm 
surgery with mixed lidocaine/bupivacaine axillary blocks. 
Keskinbora & Aydinli examined the use of bupivacaine versus bupivacaine plus 
morphine administered via a popliteal catheter for patients with chronic lower extremity 
pain. The study included a short-term single bolus treatment phase where morphine was 
noted to prolong analgesia by approximately three hours compared to bupivacaine alone. 
However, the morphine group experienced significantly greater side effects (nausea and 
somnolence). More than twice as many patients preferred treatment with bupivacaine 
alone, even though they required more rescue analgesia. 
Mays & Lipman concluded that perineural morphine provided statistically longer lasting 
pain relief than did either intramuscular morphine or perineural bupivacaine. 
Atef et. al, concluded that  2mg of morphine added as an adjuvant to the local anaesthetic 
during TAP block significantly reduced postoperative pain intensity after inguinal 
herniorrhaphy. 
 
 
 
 
 
 


9 
 
OBJECTIVES 
Primary Objective 
• To assess the duration and quality of postoperative analgesic effect of morphine as 
an adjunct to ropivacaine in a single shot USG guided FICB in patients undergoing 
ORIF for fracture femur under spinal anaesthesia. 
 
Secondary Objectives 
• To compare the requirement of post-operative rescue analgesics following a single 
shot USG guided FICB with ropivacaine alone and ropivacaine with morphine in 
patients undergoing ORIF for fracture femur under spinal anaesthesia. 
• To compare postoperative sedation score using modified Ramsay Sedation Scale 
between two groups. 
• To compare the postoperative pain scores at 0, 4, 6, 12, 24 h between two groups 
and use of rescue analgesics. 
• To compare the haemodynamics postoperatively between two groups. 
• To compare the occurrence of any postoperative complications (bradycardia, 
hypotension, PONV, respiratory depression) between two groups. 
 
 


10 
 
RESEARCH HYPOTHESIS (Null Hypothesis) 
Morphine added to ropivacaine in USG guided FICB does not prolong the duration of 
analgesia and minimize the requirement of postoperative rescue analgesics following 
femoral fracture surgeries. 
MATERIAL AND METHODS  
a. Type of study design:  
This is a prospective randomized double blind clinical trial. 
It will include patients of American Society of Anaesthesiologists physical status (ASA 
PS) I and II, scheduled for ORIF for proximal femur fractures divided in two equal 
groups. 
b. Population/Participants:  
• Group A - Ropivacaine 0.375% 20ml with NS 2ml for FICB 
• Group B - Ropivacaine 0.375% 20ml with morphine (1mg/ml) 2ml for FICB 
c. Population/Participant’s selection criteria  
I. 
Inclusion criteria:  
All patients undergoing elective femur surgery under spinal anaesthesia  
•  Age group (18-65 years) 
• ASA physical status I and II 
 


11 
 
II. 
Exclusion criteria:  
All patients with 
• Not willing to participate in the study 
• Other painful co-morbidities (neuropathies) 
• Allergy or any contraindication to study medication 
• Psychiatric disorder 
• Coagulopathy   
• Infection at the site of the block  
• Use of other modes of anaesthesia or analgesia besides spinal 
anaesthesia. 
d. Setting: Department of Anaesthesiology and Critical Care, BPKIHS 
e. Probable Study period: One Year 
f. Ethical Clearance:  
Approval of this study will be obtained from the BPKIHS Institutional Review 
Committee and informed written consent for the procedure will be obtained from 
all the eligible patients. Every patient will have the right to withdraw from the study 
at any time. 
g. Conflict of Interest: No conflict of interest 
h. Sampling Technique: Via a computer generated random number sequence 


12 
 
i. Method of Randomization and blinding 
Based on the computer generated random number table, patients will be assigned 
to either Group A or Group B. 
Sequentially numbered white envelopes will be used with study medication 
mentioned inside. The investigator observing and recording the outcome will be 
kept unaware regarding the medication group. At the same time subjects will be 
unaware of the nature of the drug used. The group allocation will be revealed only 
after analysis of the data. 
METHODS (INTERVENTION / PROCEDURE): 
a. Instruments and drugs 
Equipment needed includes the following: 
• Ultrasound machine with linear transducer (6-14 MHz), sterile sleeve, and gel 
• Standard nerve block tray 
• 20-mL syringes 
• 80- to 100-mm, 22-gauge needle 
• Sterile gloves 
Drugs needed include the following: 
• 20 ml of 0.375% ropivacaine 


13 
 
• 2 ml of 1mg/ml morphine 
• 2 ml of normal saline 
b. Follow up of subjects: The subjects will be followed till 24 hours after the surgery.  
c. Anaesthesia technique: 
All recruited patients and their relatives / attendants will be informed regarding the 
study, medication being used and expected co-operation required during pre-
anaesthetic check up in the ward, the evening before surgery. Informed and written 
consent will be obtained for accepting participation in the study. During the visit, 
patient will be familiarized and explained about the use of numeric rating scale 
(NRS) for pain assessment. (0= No pain, 1-3= Mild pain, 4-6= Moderate pain, 7-
10= Severe pain). 
Ramsay sedation scale (RSS) will also be explained in simple language which 
patient can understand. All the patients will be pre-medicated with Tab. Lorazepam 
1-2mg given orally night before and in the morning of surgery. 
On the day of operation, a vein of moderate caliber on the dorsum of the non-
dominant hand will be chosen and an intravenous line (IV) will be opened with an 
18 G IV cannula. Pre hydration will be done with Ringer’s lactate solution 20ml/kg 
just prior to administration of subarachnoid block (SAB). In the operation theatre 
standard monitoring devices will be attached to monitor electrocardiograph (ECG), 
pulse-oximeter (SpO2), non-invasive blood pressure (NIBP) together with heart 
rate (HR). 


14 
 
In the operating table patient will be properly positioned for spinal anaesthesia. 
Spinal anaesthesia will be administered in sitting position using bupivacaine 
(hyberbaric) 0.5% (2.5 - 3 ml). The level of sensory block obtained will be checked 
by using sterile needle. Motor block will be assessed by grading the motor power 
of the muscles (0 to 5).  During intraoperative period all the patients’ ECG, HR, 
SpO2 and NIBP will be monitored as per the institute’s routine protocol. After the 
completion of surgery and application dressing on the surgical wound the patient 
will be positioned supine. The skin will be disinfected and the transducer will be 
positioned to identify the femoral artery and the iliopsoas muscle and fascia iliaca. 
The transducer will be moved laterally until the sartorius muscle is identified. After 
a skin wheal is made, the needle will be inserted in-plane. As the needle eventually 
pierces through the fascia, pop will be felt and the fascia will be seen to "snap" 
back on the ultrasound image. After negative aspiration, 1 to 2 ml of the drug will 
be injected to confirm the proper injection plane between the fascia and the 
iliopsoas muscle. If local anaesthetic spread occurs above the fascia or within the 
substance of the muscle itself, additional needle repositions and injections will be 
made. The drug will be injected in aliquots of 5ml alternating with aspiration. The 
success of the block will be predicted by documenting the spread of the local 
anaesthetic toward the femoral nerve medially and underneath the sartorius 
muscle laterally. This time point will be considered as zero hour for our study. 
Experienced anaesthesiologists not involved in the study will perform the block. 
HR, mean arterial blood pressure(MAP), SpO2, sedation score, NRS for pain will 
be recorded at 0h, 4h, 6h, 12 h and 24h postoperatively. 


15 
 
Sedation will be assessed using Modified Ramsay’s sedation scale (MRSS) from 
1-6 as follows: 
1= anxious, agitated, restless 
2=   co-operative, oriented, tranquil 
3= responds to command only 
4= brisk response to light glabellar tap or loud noise 
5 = sluggish response to light glabellar tap or loud noise 
6= no response  
The pain intensity will be measured regularly at intervals mentioned above by 
Numeric Rating Scale.  
0 
No Pain 
1–3 
Mild Pain (nagging, annoying, interfering little with activities of daily 
living (ADLs)) 
4–6 
Moderate Pain (interferes significantly with ADLs) 
7–10 
Severe Pain (disabling; unable to perform ADLs) 
 
Adverse events observed in the intraoperative and postoperative period, defined 
as follows, will be noted. 
• hypotension (20% decrease relative to baseline MAP) requiring a fluid bolus  


16 
 
• bradycardia (HR <50 bpm) requiring atropine  
• nausea, vomiting  
• pruritis  
• hypoxemia (SpO2<90%) or  
• any need for additional medication.  
Blood loss will be calculated and will be replaced if more than allowable blood loss. 
Pain will be assessed using NRS postoperatively. Patient will be given Injection 
Paracetamol 15mg/kg after the surgery and then 6 hourly in the postoperative 
period. Nursing staff will be directed to administer Inj. Tramadol 50mg IV slowly 
when NRS > 3 (rescue analgesia) and Inj. Ondansetron 4mg if the patient 
complains of nausea or vomiting. The time between the block and the first 
analgesic request will be recorded as duration of analgesia. Total dose of rescue 
analgesics and antiemetics (Tramadol and Ondansetron) consumed in the 
postoperative period will be recorded. 
In the post-operative period in the ward, acceptance of the procedure and 
satisfaction level will be asked to the patient according to Likert scale.  
Likert scale  
1 = Strongly dissatisfied  
2 = Dissatisfied 
3 = Neutral 
4 = Satisfied 
5 = Strongly satisfied 
OUTCOME MEASURES 


17 
 
a. Primary Outcome Measures:  
Duration of analgesia  
b. Secondary Outcome Measures  
Total dose of rescue analgesics required in the postoperative period, numeric 
rating scale (NRS) for pain, Sedation score 
DATA MANAGEMENT AND STATISTICAL ANALYSIS 
a. 
Data handling  
 
Data will be entered in Microsoft Excel 2016 and converted into Statistical 
package for social sciences (SPSS 11.5) for statistical analysis. 
b. Coding  
Alpha numerical code will be used. 
c. 
Monitoring  
Data will be entered after every day of work. 
d. Statistical methods proposed  
• Independent paired t test to compare the mean between two groups. 
• Paired t test to compare the mean values before and after the study drug 
administration within the same group. 
• Chi square test to compare the non-paremetric variables. 
Probability value will be considered significant when p<0.05. 
e. 
Calculation of the sample size 


18 
 
This study will consider 95% confidence interval and 80% power to estimate the 
sample size. For this purpose, taking into account the pre-test results, Group A mean 
(μ1) = 6.6 hours, Group B mean (μ2) = 8.6 hours and combined standard deviation (σ) 
= 2.27.  
Now, using the following formula for sample size estimation 
n =
2σ2 (Zα 2
⁄ + Z𝛽)
2
(μ1 −μ2)2
 
Where, 
Zα 2
⁄ = 1.96 at 95% confidence interval 
Zβ = 0.842 at 80% power 
sample size becomes 32 in one arm. Adding 10% in for bias and data loss, sample 
size becomes 35 in each group. So, considering as above, n = 35 in each group i.e 
total sample size becomes 70.  
 
 
 
REFERENCES  
1. Bazin, J.E. et al., 1997. The addition of opioids to local anaesthetics in brachial 
plexus block : the comparative effects of morphine , buprenorphine and sufentanil. 


19 
 
pp.858–862. 
2. Biebuyk, J.F., 1990. the metabolic response to stress. Anesthesiology, 73, pp.308–
327. 
3. Bourke, D.L. & Furman, W.R., 1993. Improved postoperative analgesia with 
morphine added to axillary block solution. Journal of Clinical Anesthesia, 5(2), 
pp.114–117. 
4. Cuignet, O., Mbuyamba, J. & Pirson, J., The Long-Term Analgesic Efficacy of a 
Single-Shot Fascia Iliaca Compartment Block in Burn Patients Undergoing Skin-
Grafting Procedures. , pp.409–415. 
5. Dahl, A., 1988. Perineuronal morphine : a comparison with epidural morphine. , 
43(October 1987), pp.463–465. 
6. Dalens, B., Vanneuville, G. & Tanguy, A., 1989. Comparison of the Fascia Iliaca 
Compartment Block with the 3-in-1 Block in Children. Anesthesia & Analgesia, 
69(6), p.705-713. 
7. Finlayson, B.J. & Underhill, T.J., 1988. Femoral nerve block for analgesia in 
fractures of the femoral neck. Archives of emergency medicine, 5(3), pp.173–176. 
8. Ganesan, I., Ravi, S. & Krishnamoorthy, K., 2011. Fascia Iliaca Compartment 
block using Ropivacaine 0 . 5 % for Postoperative Analgesia in Lowerlimb 
Orthopaedic Surgeries. , pp.209–212. 
9. Gessel, E.F. Van & Donald, F., 1995. Does the addition of morphine to brachial 
plexus block improve analgesia after shoulder surgery, (August). 
10. Grant, C.R.K. & Checketts, M.R., 2008. Analgesia for primary hip and knee 
arthroplasty: the role of regional anaesthesia. Continuing Education in 


20 
 
Anaesthesia, Critical Care & Pain, 8(2), pp.56–61. 
11. John F. Butterworth IV, David C. Mackey, J.D.W., 2013. Morgan & Mikhail’s 
Clinical Anesthesiology Fifth edition, Lange Medical Books/ Mcgraw – Hill. 
12. Kardash, K., Schools, A. & Concepcion, M., 1995. Effects of Brachial Plexus 
Fentanyl on Supraclavicular Block: A Randomized, Double-blind Study. Regional 
Anesthesia and Pain Medicine, 20(4). 
13. Keskinbora, K. & Aydinli, I., 2009. Perineural morphine in patients with chronic 
ischemic lower extremity pain: efficacy and long-term results. Journal of 
Anesthesia, 23(1), pp.11–18.  
14. Leone, S. et al., 2008. Pharmacology , toxicology , and clinical use of new long 
acting local anesthetics , ropivacaine and levobupivacaine. , (2), pp.92–105. 
15. Lopez, S. et al., 2003. Fascia Iliaca Compartment Block for Femoral Bone 
Fractures in Prehospital Care. Regional Anesthesia and Pain Medicine, 28(3).  
16. Maxwell, L. et al., 2013. Anaesthetic management of patients with hip fractures: 
an update. Continuing Education in Anaesthesia, Critical Care & Pain, 13(5), 
pp.179–183. 
17. Miller, R.D., 2015. Miller’s anesthesia Eighth Edi., 
18. Morrison, R.S. et al., 2003. The impact of post-operative pain on outcomes 
following hip fracture. Pain, 103(3), pp.303–311. 
19. Öster Svedberg, K., McKenzie, J. & Larrivee-Elkins, C., 2002. Compatibility of 
ropivacaine with morphine, sufentanil, fentanyl, or clonidine. Journal of Clinical 
Pharmacy and Therapeutics, 27(1), pp.39–45. 
20. Racz, H. et al., 1991. Evaluation of the Effect of Perineuronal Morphine on the 


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Quality of Postoperative Analgesia After Axillary Plexus Block : A Randomized 
Double-Blind Study. , pp.769–772. 
21. Saryazdi, H. et al., 2015. Comparative evaluation of adding different opiates ( 
morphine , meperidine , buprenorphine , or fentanyl ) to lidocaine in duration and 
quality of axillary brachial plexus block. 
22. Sternlo, J.E. & Hägerdal, M., 1992. Perineuronal morphine in intercostal block. 
Anaesthesia, 47(7), pp.613–615. 
23. Wambold, D., Carter, C. & Rosenberg, A.D., 2001. The Fascia Iliaca Block For 
Postoperative Pain Relief After Knee Surgery. Pain Practice, 1(3), pp.274–277.  
24. Williams, A. et al., 2008. Ultrasound Guided Fascia Iliaca Block : A Comparison 
With the Loss of Resistance Technique. , 33(6), pp.526–531 
 
 
 
 
 
 
 


22 
 
ANNEXURES  
PARTICIPANT RECORD FORM 
Sample no:                                                                             Date: 
Name:                                                                                     ID no: 
ASA PS:                                                                                  Age/Sex: 
Time of start of Anaesthesia:                                                  Weight:   
Duration of operation: 
Time of block administration: 
Measurement of parameters 
 
Parameters 
T    I    M   E 
During surgery 
 
RR 
HR 
SBP 
DBP 
MAP 
SpO2 
NRS MRSS 
0  min. 
 
 
 
 
 
 
 
 
10min 
 
 
 
 
 
 
 
 
30min. 
 
 
 
 
 
 
 
 
Postoperative 
0 h 
 
 
 
 
 
 
 
 
4 h 
 
 
 
 
 
 
 
 
8 h 
 
 
 
 
 
 
 
 
12 h 
 
 
 
 
 
 
 
 
24 h 
 
 
 
 
 
 
 
 
 
Time 
Parameters 
Rescue analgesics (Inj 
Tramadol) 
Rescue antiemetics (Inj 
Ondansetron) 
0-4 hours 
 
 
4-8 hours 
 
 
8-12 hours 
 
 
12-24 hours 
 
 


23 
 
Intra operative complications: 
• Hypotension: 
• Bradycardia: 
• Nausea and vomiting: 
• Respiratory depression: 
• Others: 
• Any medication used: 
Level of SAB at the time of FICB: 
 Time of administration of first dose of rescue analgesia: 
Total duration analgesia with block: 
Total dose of IV Tramadol given: 
Total dose of IV Ondansetron given: 
Postoperative complication (Nausea/ vomiting/ bradycardia/ hypotension/ respiratory 
depression: 
I would like to repeat the procedure if there is a need in the future: Yes/No  
Patient’s satisfaction level (Likert scale- 1 = Strongly dissatisfied, 2 = Dissatisfied, 3 = 
Neutral, 4 = Satisfied, 5 = Strongly satisfied): 
 
 


24 
 
PARTICIPANT INFORMATION SHEET 
B.P. KOIRALA INSTITUTE OF HEALTH SCIENCES 
DHARAN, NEPAL 
POSTOPERATIVE ANALGESIC EFFECT OF MORPHINE ADDED TO ROPIVACAINE 
FOR FASCIA ILIACA COMPARTMENT BLOCK FOLLOWING FEMORAL 
FRACTURE SURGERIES 
 
1. Why are we giving you this paper? 
We will explain this note to you now and we would like you to read it. 
 
2. Who will be conducting this study? 
Dr. Pankaj Baral 
Junior Resident 
Department of Anaesthesiology and Critical Care 
BPKIHS, Dharan, Nepal 
Contact no. 9856037077 
 
3. Why is this study being done? 
The purpose of this study is to assess duration and quality of postoperative 
analgesia and the requirement of postoperative rescue analgesics by using 
morphine as an adjunct to ropivacaine in USG guided FICB in patients undergoing 
ORIF for femur surgeries under spinal anaesthesia. 
 
4. Why are we inviting you to participate in the study? 
There have been no studies designed to assess the duration, quality of 
postoperative analgesia and requirement of postoperative rescue analgesics after 
giving ropivacaine with morphine for fascia iliaca block in patients undergoing 
femoral fracture surgeries under SAB for post-operative pain management. So, you 
are invited to participate in this study. 
 


25 
 
5. What will be happening if you accept to enter this study? 
Basic information about you will be taken. You will be randomized into two groups; 
one group will be given single shot FICB using 20 ml 0.375% ropivacaine with 2ml 
morphine (1mg/ml) after the completion of surgery and the other group will be given 
single shot FICB using 20 ml 0.375% ropivacaine with 2ml normal saline. The total 
requirement of postoperative rescue analgesics, NRS score, duration of analgesia 
and sedation score will be assessed at intervals till 24h. 
 
6. Confidentiality 
All information collected during this study regarding you will be confidential. Reports 
will be generated on the outcome of the study without your name appearing 
anywhere. The participation in the study is voluntary and the honesty of your answer 
will be very important. The findings of this study will be analysed and published in 
peered review journal for dissemination. 
 
7. Are you facing any risk in this study? 
The drugs have been proven to be safe in previous studies. Possible side effect of 
morphine used in this block is excessive sedation postoperatively.  
 
8. Are there any benefits of this study for you?  
This study will help us to determine if the use of morphine as an adjunct to 
ropivacaine in FICB decreases the requirement of postoperative rescue analgesics. 
Your participation in the study is free of charges and you will not be paid for 
participating in the study. 
 
9. How to refuse or give consent? 
You have every right to agree or refuse to participate in this study.  
You will not be penalized or be blamed should you refuse to enter in this study. 
Once you enter this study, we hope off course that you will continue with us for the 
full time period of the study. Even after entry, you are free to withdraw any time you 
feel like and for the same no one will make you pay or give you any other sanctions. 


26 
 
जानकारी पर्ा 
jL=kL= sf]O{/fnf :jf:Yo lj1fg k|lti7fg 
 
 
w/fg, g]kfn 
;dLk:y x8\8L zNolqmof (Femoral Fracture Surgeries) kZrft x'g] b'vfO{ sd ug{sf] nflu FICB df 
Ropivacaine sf nflu Ps ;xfossf ?kdf Morphine sf] k|of]u . 
 
!_ tkfO{nfO{ of] sfuh lsg lbOP{sf] 5 < 
 
o; sfuhdf of] cWoogsf] af/] hfgsf/L 5 h'g k9]/ tkfO{n] o;df efu lng'x'g]5 . 
@_ of] cg';Gwfg s;n] ul//x]sf 5g\ < 
 
8f= k+sh a/fn 
 
h'lgo/ /]l;8]G6 
 
jL=kL= sf]O{/fnf :jf:Yo lj1fg k|lti7fg, w/fg g]kfn 
 
;Dks{ g+M (*%^)#&)&& 
#_ of] cg';Gwfg lsg ul/b}5 < 
 
P]g:y]l;of cGtu{t ;dLk:y x8\8L zNolqmof kZrft x'g] b'vfO{ sd ug{sf] nflu FICB df Ropivacaine 
sf nflu Ps ;xfossf ?kdf Morphine sf] k|of]u u/L zNolqmof kZrft x'g] b'vfO{ / b'vfO{ sd ug{ 
rflxg] cf}ifwLsf] dfqfsf] cWoog ug{sf] nflu ul/+b} 5 . 
$_ tkfO{nfO{ lsg cfdlGqt ul/Psf] 5 < 
;dLk:y x8\8L zNolqmof (Femoral Fracture Surgeries) kZrft x'g] b'vfO{ sd ug{sf] nflu FICB 
df Ropivacaine sf nflu Ps ;xfossf ?kdf Morphine sf] k|of]u u/L zNolqmof kZrft x'g] b'vfO{ 
/ b'vfO{ sd ug{ rflxg] cf}ifwLsf] dfqfsf] cWoog ug{sf] nflu xfd|f] kl/j]zdf s'g} cWoog gePsf]n] . 
 
 


27 
 
%_ o; cWoog cGtu{t s] x'g]5 < 
 
tkfO{nfO{ ;fdfGo hfgsf/L lnOg]5 . sDKo'6/åf/f pTkGg c+ssf] d2tn] b'O{ ;d'x FICB df 
Ropivacaine+Morphine / csf{] ;d'xdf Ropivacaine dfq k|of]u x'g]5 . zNolqmof kZrft zNolqmof 
kl5 b'vfO{sf] cj:yf,b'vfO{ sd ug{ rflxg] cf}ifwLsf] dfqf / a]xf];L kl5 nfUg] lgb|fsf] cj:yfsf] cWoog 
zNolqmofsf] @$ 306f leq ul/G5 .  
^_ uf]klgotf 
 
tkfO{sf] ;a} hfgsf/L uf]Ko /flvg]5 . tkfO{sf] gfd st} pNn]lvt x'g] 5}g . tkfO{sf] ;xeflutf tkfO{sf 
:j–OR5fdf x'g]5 / pQ/ lbbf OdfGbf/Ltf dxTjk"0f{ x'g]5 .  
&_ o; cWoogdf ;fd]n x'gsf nflu ;Defljt hf]lvdx? s] s] x'g < 
 
of] cf}ifwL cg'ejL k|of]ustfsf sfydf ;'/lIft 5g\ . ;fdfGo k|lts'n c;/ afx]s c? cltl/Qm c;/x? 
Go'g 5g\ . Morphine n] lgGb|f nufpg] ;Defjgf x'G5 .  
*_ o; cWoogdf ;fd]n x'g'sf ;Defljt nfex? s] s] x'g < 
 
of] cWoogdf FICB df Ropivacaine sf nflu Ps ;xfossf ?kdf Morphine sf] k|of]uubf{ b'vfO{ sf] 
cjlw / u'0f / zNolqmof kZrft rflxg] b'vfO{ sd ug]{ cf}ifwLsf] dfqf 36\g] jf g36\g] hfgsf/L k|fKt x'G5  
.  
tkfO{+nfO{ o; cWoogdf ;fd]n x'+bf s'g} cfly{s ;xof]u lbOg] 5}g . 
(_ cWoogdf ;fd]n ePkl5 s] tkfO{n] cfkm\gf] ljrf/ ab\lng ;Sg'x'G5 < 
 
o; cWoogdf ;xefuL x'g d~h'/L lbg] glbg] lg0f{o ug{ tkfO{sf] k'/f clwsf/ 5 . ;xefuL x'g grfxg' 
ePdf klg tkfO{nfO{ s'g} ;hfo jf hl/jfgf x'g] 5}g . / cGo pkrf/af6 al~rt ul/g] 5}g . tkfO{ s'g}klg 
;do o; cWoogaf6 aflxl/g ;Sg'x'g]5 .  
 
 
 
 


28 
 
PARTICIPANT INFORMED CONSENT FORM 
Protocol Number: _______________ 
Participant Identification number for the study______________ 
Title of the research: Postoperative analgesic effect of morphine added to ropivacaine for fascia iliaca 
compartment block following femoral fracture surgeries 
Name of the candidate: ______________________________________, aged___________years, 
Address 
_____________________________________________________________. 
Telephone: 
(residence) ______________(mobile) _____________(friend/parents) ___________ Email___________, 
The content of the information sheet dated___________ that was provided has been read carefully by 
me/explained in detail to me, in a language that I comprehend, and have fully understood the contents. I 
confirm that I have had the opportunity to ask questions. 
The nature and purpose of the study and its potential risks/ benefit and expected duration of the study, and 
other relevant details of the study have been explained to me in detail. I understand that my participation is 
voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or 
legal right being affected. 
I understand that the information collected about me from my participation in this research and sections of 
any of my medical notes may be looked at by responsible individuals from BPKIHS. I give permission for 
these individuals to have access to my record. 
I hereby give consent to take part in the above study and allow to perform the procedure and any other 
medical service that may become necessary during the procedure. 
I also consent for medical photographs/ video and I have been informed that these photographs/ video will 
be used without revealing the identity. I understand that these along with the information I provide may be 
used in my medical record, for purpose of publication in textbook or medical journal and dissertation 
purpose, or for medical education. 
The consent form has been signed by me when I was not under the influence of any drugs. 
Patient’s signature _________________ 
Researcher/Doctor’s signature _____________________ 
Date: 
Witness signature __________________ 
If illiterate 
I have witnessed the accurate reading of the consent form to the potential participant, and the 
individual has had the opportunity to ask questions and to understand the nature of study. I confirm 
that the individual has given consent freely. 
Thumb print of participant 
Researcher/Doctor’s signature ________________ 
Date: 
 
Witness signature __________________ 
 


29 
 
मन्जुरीनामा पत्र 
 
 प्रोटोकल नं: _________________________________ 
सहभागी आइ डी नं: ___________________________ 
 
अध्ययनको विषय: सममपस्थ हड्डी शल्यक्रिया पश्र्ात् हुने दुखाई कम गनाको लागग FICB मा Ropivacaine का लागग 
एक सहायकका रुपमा Morphine को प्रयोग ।  
 
सहभागीको नाम:________________________________________________________________  उमेर: _________ 
ठेगाना: _______________________________________________________________________________________ 
टेमलफोन नं:  
घर ______________________________ 
 
मोबाइल ____________________________  
अविभािक ________________________ 
 
इमेल_______________________________ 
 
ममतत_________ मा मलाई ददइएको जानकारी पर्ा राम्ररी पढेको छु/ मैले बुझ्ने भाषामा बुझाइएको छ र मैले बुझेको 
छु । मलाई प्रश्न सोध्ने मौका पतन ददइएको छ । अध्ययनको प्रकृतत, उद्देश्य र जोखखम/लाभ, अध्ययनको अनुमातनत 
समय र बृष्ततत जानकारी मलाई व्याख्या गररएको छ । मेरो सहभागगता स्िैष्छछक हो र म जुनसुकै बेला अध्ययनबाट 
कुनै कारण बबना मेरो स्िास््य उपर्ार र कानुनी अगिकार प्रभावित नभई बादहररन सक्ने छु भन्ने बुझेको छु । 
अध्ययनको िममा मेरो र मेरो उपर्ारको बारेमा मलइएको जानकारी बब वप के आइ एर् एसका ष्जम्मेिार ब्यष्क्तहरुले 
हेना सक्नेछन भन्ने मैले बुझेको छु । मेरो रेकडाहरुमा तनजहरुको पहुुँर्को लागग अनुमतत ददन्छु । म यस अध्ययनमा 
मेरो सहभागगताको, अध्ययनमा गररने काया र स्िास््य सेिाको लागग मन्जुररनामा ददन्छु । 
अध्ययनको िममा मेरा तष्स्िर र र्लगर्त्र मलन पतन म मन्जुर छु र मेरो पररर्य नखुलाई यी तष्स्िर/र्लगर्त्र को 
प्रयोग गररनेछ भन्ने मलाई जानकारी छ । यी संगसंगै मेरो जानकारी मेडडकल रेकडा, क्रकताबमा प्रकाशन गना, मेडडकल 
जनालमा प्रकाशन गना र स्िास््य मशक्षाको लागग प्रयोग गना सक्रकने छ भन्ने मैले बुझेको छु । यो मन्जुररनामा म 
कुनै औषिीको प्रभाि नपरी हस्ताक्षर गदाछु । 
 
 
बबरामीको सही ________________________अनुसन्िानकता/डाक्टरको सही_____________  
ममतत  
साक्षीको सही ___________________________ 
 
तनरक्षरको हकमा 
यो मन्जुरीनामा बबरामीलाई सही तररकाले मेरो अगाडी पढेर सुनाइएको छ । बबरामीलाई अध्ययनको प्रकृततको बारेमा 
बुझ्न र प्रतन सोध्न ददइएको छ । बबरामीले खुला रुपमा यो मन्जुरीनामा गरेको मैले पुष्तट गदाछु ।  
 
बबरामीको औंठा छाप 
अनुसन्िानकता/डाक्टरको सही_____________  
ममतत 
साक्षीको सही ____________________