Quadratus Lumborum Block After Cesarean Section: Analgesic Efficacy of Different Concentrations of Local Anesthetics. A Randomized Clinical Trial
Phase: NA
Conditions: Outcome Measures
Sponsor: Danat Al Emarat Hospital

Quadratus Lumborum Block After Cesarean Section: Analgesic Efficacy of 
Different Concentrations of Local Anesthetics. A Randomized Clinical Trial   
 
Unique Protocol ID: 
RP DAE/2022/102 
 
Date: August 2022 

DAE Research & Ethics Form / March 2020 
Danat Al Emarat Hospital for Women & Children 
RESEARCH ETHICS COMMITTEE (REC) 
 
APPLICATION FORM 
 
 
 
DAE REC will review all applications to ensure that the proposed research meets 
acceptable standards with respect to scientific merit, design, ethical and United Arab Emirates 
cultural propriety, patient safety and convenience, and relevance. Proposals which meet these 
requirements will be approved. Advice will be provided for those projects for which the 
Committee feels there could be improvement.  
 
 
Proposals should be submitted on an application form in an electronic form. The signed 
original form should be provided together with the support documents as detailed on the check 
list provided. Incomplete submissions will be returned to the applicant. Principle investigators 
may be called to the meeting to discuss their proposals. Applicants will be notified as early as 
possible of the Committee’s decision with any appropriate explanations. Brief annual and final 
reports are required for approved proposals. All sections of the application must be completed. 
Enter “not applicable (N/A)” where appropriate.  
 
 
All application forms should be submitted to 
Ms. Sara Bachar 
DAE Research and Ethics Committee Coordinator 
at: research@danatalemarat.ae and sara.bachar@danatalemarat.ae 
 
 
 
 
 

DAE Research & Ethics Form / March 2020 
2 
Title of the project 
 
 
 
 
Abstract (100-150 words) 
 
For Committee use only: 
 
Research Proposal Number/ 
version 
 
Date received 
 
Reviewer 1 
 
Reviewer 2 
 
Review Deadline  
 
Committee Review Deadline  
 
Date of Committee Decision: 
 
Decision: 
 
QLB is an injection of a local anesthetics around the quadratus lumborum muscle. It uses a fascial 
compartment path to extend the distribution of local anesthetics into the posterior abdominal wall and 
paravertebral space. Acute post C-section pain is a leading anesthetic concern for women; a key 
determinant of maternal satisfaction; may lead to persistent postoperative pain; is a predictor of 
postpartum depression; and can reduce early breastfeeding success. Effective postoperative analgesia 
should, therefore, be prioritized to improve outcomes following caesarean delivery. Our study is a 
Double-blinded, randomized and controlled trial. 
A written, informed consent is discussed with and signed by all participants, and they are randomly 
assigned into one of two groups; (Group 1) to receive bilateral QLB with 0.125% bupivacaine 0.2 
ml/kg, (Group 2) to receive bilateral QLB with 0.25% bupivacaine 0.2 ml/kg. For all patients, spinal 
anesthesia is performed with ultrasonography guidance in a standardized manner using hyperbaric 
bupivacaine 15mg and fentanyl 25 μg. 
At the end of the procedure in the supine position, all participants receive bilateral QLBs performs 
under ultrasound guidance and aseptic technique. The internal oblique muscle is identified and 
followed laterally to the lateral interfacial triangle sitting above the quadratus lumborum muscle. 
Results will be reported as 
1. Total number of PCA morphine demands and the actual doses delivered at predetermined time 
intervals (1, 2, 4, 6, 12, 24 and 48 h) after surgery 
2. Record of supplemental and regular analgesics.  
3. Visual analogue score for pain at rest (Static) and with movement (dynamic) defined as the 
elevation of the head and shoulders off the pillow from the supine position), (0, no pain; 10, worst 
pain imaginable). 
4. Opioids-related side effects i.e., sedation scores (Ramsay scale), itching (0, none; 1, mild; 2, 
moderate; 3, severe), nausea (0–3 scale: 0, none; 1, mild; 2, moderate; 3, severe or vomiting), 
5. Block-related complications (i.e., hematoma, organ injury, local anesthetic systemic toxicity, 
sepsis, and block failure). 
Quadratus lumborum block after cesarean section: analgesic efficacy of different 
concentrations of local anesthetics. A Randomized Clinical Trial 

DAE Research & Ethics Form / March 2020 
3 
PROJECT INVESTIGATORS 
The purpose of this section is to document the person(s) responsible for the study. 
 
Name, Affiliation, and Position of Principal Investigator 
    Signature 
  Jinan Jameel Al-Aloosi 
Danat Al Emarat Hospital 
Consultant Anesthesiologist 
 
 
Name and Signature of all investigators: 
 
 
 
 
 
 
Name, Affiliation, and Position 
Signature 
 
Rabiah Noueihed, Danat Al Emarat Hospital 
Consultant Anesthesiologist 
 
 
 
 
 
 
 
 
 
 
 
Approval/Endorsement of Head of Department or Deputy 
             Signature 
 
 
 
 
Name and contact address of Investigator to which correspondence should be sent: 
 
Jinan Ahmed Jameel Al-Aloosi ; jinan.jameel@danatalemarat.ae 
Mob. 0507291195 
 
Rabiah Noueihed ; rabiah.noueihed@danatalemarat.ae 
Mob. 0526925514 
 
 
 
  
 
Study Timeframe 
Estimated study commencement date 
 
 
Estimated study end date 
 
August 2022 
 
February 2023 
 
C. 
DETAILS OF PROPOSED RESEARCH 
Please complete all sections succinctly and cite pertinent supportive references.   
 

DAE Research & Ethics Form / March 2020 
4 
C1. 
Overall objective(s), specific aim(s) and hypotheses. 
QLB is an injection of a local anesthetics around the quadratus lumborum muscle. It uses a fascial 
compartment path to extend the distribution of local anesthetics into the posterior abdominal wall 
and paravertebral space. This central effect can be of vital importance when managing the visceral 
pain after caesarean section. 
 Many studies have shown that the inclusion of quadratus lumborum block to a multimodal 
analgesic regimen would reduce pain scores, opioids consumption, and prolonging time to first 
rescue analgesic after cesarean delivery.  
However, the dose and concentration of the local anesthetic used among the studies are varied, 
and literature search identified no randomized controlled trial which looked at the concentration 
-response of local anesthetic to optimize the concentration resulting in the best pain relief. 
The aim. 
To design a prospective randomized controlled trial to compare the analgesic efficacy of 2 different 
concentration of Bupivacaine to standardize postoperative analgesic protocol used for QLB after 
caesarean section. 
The objective. 
We hypothesized that using the higher concentration (0.25%) of local anesthetic (Bupivacaine) would 
increase the analgesic effect without increasing the side effects and complications. 
C2. 
Rationale & Background (Please include a literature review).  
Caesarean delivery is the most common inpatient surgical procedure performed worldwide; 
improving the perioperative care of parturient has significant global implications [1].  
Acute postpartum pain is a leading anesthetic concern for women [2]; is a key determinant of 
maternal satisfaction [3]; may lead to persistent postoperative pain [4, 5]; is a predictor of 
postpartum depression [6]; and can reduce early breastfeeding success [7]. Effective 
postoperative analgesia should, therefore, be prioritized to improve outcomes following 
caesarean delivery. In an effort to apply the latest evidence-based practices towards improving 
maternal outcomes, Enhanced Recovery after Surgery (ERAS) protocols have been adapted for 
cesarean delivery, with one of its key components being the optimization of post-cesarean 
delivery analgesia via a multimodal, opioid-sparing approach [8,9]. While neuraxial 
administration of opioids has been shown to be a safe and effective means of managing post-
cesarean delivery pain, however, they are commonly associated with adverse effects such as 
nausea, vomiting, sedation, pruritus and have the potential for misuse [10], which have prompted 
the search for alternative non-opioid analgesic adjuncts. Regional anesthetic techniques are 
commonly included in ERAS protocols due to their proven efficacy in improving postoperative 
analgesia and the consequent reduction in nausea and vomiting [8,9]. Truncal nerves block such 
as transversus abdominis plane (TAP) blocks and quadratus lumborum blocks (QLB), are 
increasingly being incorporated into obstetric anesthetic practice to improve analgesic outcomes 
[11–16]. QLB involves local anesthetic infiltration adjacent to the quadratus lumborum muscle, 
which may facilitate the spread of local anesthetic into the thoracic paravertebral space [17]. By 
blocking both somatic nerves and the lower thoracic sympathetic trunk, the QLB could 
theoretically relieve both somatic and visceral pain, providing superior analgesia compared to the 
TAP block, which mainly targets somatic pain [18]. Quadratus lumborum blocks have been 
studied in several obstetric randomized controlled trials, and advocates of this technique postulate 
that it is associated with superior analgesic outcomes when compared with either control or TAP 
blocks [18]. Several studies have used different doses and concentrations of local anesthetics for 
QLB. However, a literature search identified no randomized controlled trials that evaluated the 
optimal concentration of local anesthetics used for QLB after caesarean section (19,20). We 
designed a prospective randomized controlled trial to compare the analgesic efficacy of 2 
different concentrations of Bupivacaine to standardize postoperative analgesic protocol used for 

DAE Research & Ethics Form / March 2020 
5 
QLB after caesarean section. QLB aims to infiltrate local anesthetic into a fascial plane that can 
reach the paravertebral space by dissecting the space behind the quadratus lumborum muscle. 
Blanco et al. performed studies with contrast-enhanced MRI and examined the spread of contrast 
within the fascial plane. The MRI images showed that injection at the posterior border of the 
quadratus lumborum muscle, between the quadratus lumborum and the latissimus dorsi muscles 
(QLB 2), may provide a more predictable spread of local anesthetic into the paravertebral space. 
This method has the advantage of a more superficial point of injection with better ultra-
sonographic resolution. It is also potentially safer because the needle tip is separated from the 
peritoneum by the quadratus lumborum muscle, reducing the risk of intraperitoneal injection and 
bowel injury (18). 
Blanco et al. in his study on 2015 used bupivacaine 0.2 ml/kg at a conc. of 0.125%. 
 
References: 
 
1. Molina G, Weiser TG, Lipsitz SR, et al. Relationship between cesarean delivery rate 
and maternal and neonatal mortality. Journal of the American Medical Association 2015; 
314: 2263. 
2. Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient 
preferences for anesthesia outcomes associated with cesarean delivery. Anesthesia and 
Analgesia 2005; 101: 1182–7. 
3. Yurashevich M, Carvalho B, Butwick AJ, Ando K, Flood PD. Determinants of 
women’s dissatisfaction with anaesthesia care in labour and delivery. Anaesthesia 2019; 
74: 1112–20. 
4. Weibel S, Neubert K, Jelting Y, et al. Incidence and severity of chronic pain after 
caesarean section: a systematic review with meta-analysis. European Journal of 
Anaesthesiology 2016; 33: 853–65. 
5. Landau R, Bollag L, Ortner C. Chronic pain after childbirth. International Journal of 
Obstetric Anesthesia 2013; 22: 133–45. 
6. Eisenach JC, Pan PH, Smiley R, Smiley R, Lavand’homme P, Landau R, Houle TT. 
Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain 
and postpartum depression. Pain 2008; 140: 87–94. 
7. Hirose M, Hara Y, Hosokawa T, Tanaka Y. The effect of postoperative analgesia with 
continuous epidural bupivacaine after cesarean section on the amount of breast feeding 
and infant weight gain. Anesthesia and Analgesia 1996; 82: 1166–9. 
8. Fay EE, Hitti JE, Delgado CM, et al. An enhanced recovery after surgery pathway for 
cesarean delivery decreases hospital stay and cost. Am J Obstet Gynecol 
2019;221:349.e1–9. 
9. Teigen NC, Sahasrabudhe N, Doulaveris G, et al. Enhanced recovery after surgery 
(ERAS) at cesarean to reduce postoperative length of stay: a randomized controlled trial. 
Am J Obstet Gynecol 2020;222:372.e1–372.e10. 
10. Gadsden J, Hart S, Santos AC. Post-cesarean delivery analgesia. Anesth Analg 
2005;101:S62–9. 
11. Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of 
peripheral nerve blocks for cesarean delivery analgesia. Regional Anesthesia and Pain 
Medicine 2020; 45: 52–62. 

DAE Research & Ethics Form / March 2020 
6 
12. Patel SD, Sharawi N, Sultan P. Local anaesthetic techniques for post-caesarean 
delivery analgesia. International Journal of Obstetric Anesthesia 2019; 40: 62–77. 
13. McDonnell JG, O’Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The 
analgesic efficacy of transversus abdominis plane block after abdominal surgery: a 
prospective randomized controlled trial. Anesthesia and Analgesia 2007; 104: 193–7. 
14. Abdallah FW, Halpern SH, Margarido CB. Transversus abdominis plane block for 
postoperative analgesia after Caesarean delivery performed under spinal anaesthesia? A 
systematic review and meta-analysis. British Journal of Anaesthesia 2012; 109: 679–87. 
15. Mishriky BM, George RB, Habib AS. Transversus abdominis plane block for 
analgesia after Cesarean delivery: a systematic review and meta-analysis. Canadian 
Journal of Anesthesia 2012; 59: 766–78. 
16. Fusco P, Scimia P, Paladini G, et al. Transversus abdominis plane block for analgesia 
after cesarean delivery. A systematic review. Minerva Anestesiologica 2015; 81: 195–
204. 
17. Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum block: 
anatomical concepts, mechanisms, and techniques. Anesthesiology 2019;130:322–35. 
18. Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after 
cesarean section: a randomized controlled trial. Eur J Anaesthesiol 2015;32:812–8. 
19. Quadratus lumborum block vs. transversus abdominis plane block for caesarean 
delivery: a systematic review and network meta-analysis* K. El-Boghdadly ,1,2 N. 
Desai,1,2 S. Halpern,3 L. Blake,4 P. M. Odor,5 S. Bampoe ,5 B. Carvalho 6 and P. 
Sultan7 
20. Quadratus lumborum block for postoperative analgesia after cesarean delivery: A 
systematic review with meta-analysis and trial-sequential analysis Hon Sen Tan (MD, 
MMed)a, Cameron Taylor (MD)a, Dan Weikel (MSc)b, Karen Bartonc, Ashraf S. Habib 
(MBBCh, MSc, MHSc, FRCA).  
 
C3. 
Study Procedures 
 
a. Study design, including the sequence and timing of study procedures   
(Distinguish research procedures from routine care).  
It is a Double-blinded, randomized and controlled clinical trial. The participants are the 
patients attend the pre‐assessment anaesthesia clinic and are scheduled for elective caesarean 
section under spinal anesthesia. A written, informed consent is discussed with and signed by 
all participants. Participants are randomly assigned into one of two groups; (Group 1) to 
receive bilateral QLB with 0.125% bupivacaine 0.2 ml/kg, (Group 2) to receive bilateral QLB 
with 0.25% bupivacaine 0.2 ml/kg. For all participants, spinal anesthesia is performed with 
ultrasonography guidance in a standardized manner using hyperbaric bupivacaine 15mg and 
fentanyl 25 μg. Spinal anesthesia is considered successful when a bilateral block to T6, 
assessed by loss of cold (ice cube) and/or touch (blunt pin) are established 5 min after the 
spinal injection. Anesthetic and surgical treatment are performed in the usual manner. At the 
end of surgery, all participants receive paracetamol 1g IV and Dexketoprofen 50 mg IV. 
While in the supine position, all participants receive bilateral QLBs performs under 
ultrasound guidance and aseptic technique. All participants are continuously monitored 
throughout the performance of the block. The internal oblique muscle is identified and 
followed laterally to the lateral interfacial triangle sitting above the quadratus lumborum 

DAE Research & Ethics Form / March 2020 
7 
muscle (Posterior approach of QLB). The optimal point of injection is determined using 
hydrodissection. In the recovery room, all participants are connected to a morphine PCA 
pump set to deliver 1mg intravenous bolus on demand, with a lockout interval of 5 min and 
no background infusion. 
All participants receive regular intravenous paracetamol 1 g 6 hourly, and oral diclofenac 50 
mg at 8-hourly intervals. Intravenous ondansetron 4 mg is used to treat nausea and vomiting. 
Participants with a score of 10 in the modified Aldrete scoring system are considered eligible 
for discharge to the surgical ward. Data collection is continued on the ward for 48 h. 
b. Primary and Secondary Outcome Measures. What will be measured and how (describe 
tests that patients need to undergo?). 
The primary outcome measure of the study is the total number of PCA morphine demands 
and the actual doses delivered at predetermined time intervals (1h, 2h, 4h, 6h, 12h, 24h and 
48h) after surgery. The following variables are measured and documented: heart rate, 
respiratory rate, oxygen saturation and noninvasive blood pressure.  
The secondary outcomes are the visual analogue score for pain at rest (static) and with 
movement (dynamic) defined as the elevation of the head and shoulders off the pillow from 
the supine position), (0, no pain; 10, worst pain imaginable). Residual nerve block (the time 
to mobilization), opioids-related side effects (sedation scores (Ramsay scale), itching (0, 
none; 1, mild; 2, moderate; 3, severe), nausea (0–3 scale: 0, none; 1, mild; 2, moderate; 3, 
severe or vomiting), block-related complications (i.e., hematoma, organ injury, local 
anesthetic systemic toxicity, sepsis and block failure). Record of supplemental and regular 
analgesics. 
c. What data-collecting instruments will be used? (Measurements, questionnaires, 
interviews etc.). Please enclose a copy of these instruments. 
 
d. Study duration and number of study visits required of research participants. 
A single center between November 2022 and April 2023. No visits required after discharge. 
e. Blinding, including justification for blinding or not blinding the trial, if applicable. 
Double-blinded, randomized and controlled clinical trial 
 
C4. 
Subjects 
 
a. Study population with inclusion/exclusion Criteria  
Inclusion criteria are American Society of Anesthesiologists physical status 1 or 2 and a 
normal singleton pregnancy with a gestation of at least 37 weeks who are scheduled for 
elective caesarean section under spinal anesthesia and consented to be enrolled into the study. 
We exclude. 
a. Patient who has contraindications to spinal or regional anesthesia and patients who 
have Allergy/sensitivity/contraindication to study medications. 
b. Patient who has congenital coagulopathy or who use anticoagulants. 
c. Patients with anatomical abnormalities, localized infection 
d. History of chronic pain or regular opioid use  
e. Unable to comprehend or use the verbal rating pain scoring system 
f. Requirement for conversion to general anesthesia after spinal anesthesia or failed 
spinal. 
b.  Subject Numbers. 
98 patients each in group 1 and group 2 
 
C5. 
Study Statistics 

DAE Research & Ethics Form / March 2020 
8 
 
a. Statistical plan including sample size justification and interim data analyses. 
Assuming the mean 48-hour morphine consumption in the group 1 (bilateral QLB with 
0.125% bupivacaine 0.2 ml kg 1) to be 11 mg with standard deviation10 mg [18] and based 
on 33% difference in morphine consumption between the two groups, the sample size 
calculation indicated that 98 participants will be required in each group, with 80% power type 
I error associated with this test for null hypothesis is 5%. 
Data will be collected and entered the computer as numerical or categorical data. Statistical 
analysis will be performed using SPSS for Windows with P < 0.05 set to be statistically 
significant. The values of continuous variables will be presented as mean ± standard deviation 
and the categorical data will be described as count and percentages. Comparisons will be 
performed between the two groups using independent t tests or Mann–Whitney tests, as 
appropriate. Categorical data will be compared through Pearson Chi-square test or Fisher 
exact test. 
b. Describe randomization and/or sampling procedures. 
Participants are allocated randomly by means of computer generation sequencing. The 
allocation sequence with unique study number for each participant will be concealed in 
sequentially numbered, opaque, sealed, and stapled envelopes. This envelope will be opened 
by an anesthetist who was not involved in the study. This Anesthetist prepares the study 
medication as per the allocation and labels the syringe with the unique study number; this 
number will be used to identify the study medication and will be revealed only on completion 
of data collection at the end of the study. The investigators, participants and other healthcare 
providers who are involved in postoperative care, are blinded to the patient group allocation. 
c. Early stopping rules. 
Not Applicable 
 
D. 
ETHICAL CONSIDERATIONS 
 
 
D1.  Risks, discomforts, and safety.  
 
a. Describe risks to the participants, and steps taken to minimize these risks. 
Hypotension can be possibly related to spread of local anesthetic in the paravertebral spaces. 
Local anesthetic toxicity can be due to large volume used specially in cases of bilateral 
blocks. These two complications “Hypotension & Local anesthetic toxicity” can happen 
mainly during the first 30-60 min. after the block, and we are continuously monitoring the 
patient after the procedure in OT and in PACU. Search through systematic review and meta-
analysis showed that QLB considered as a relatively safe technique as local anesthetic 
toxicity has not been reported and the complications related to technical challenges of the 
deeper block and inadequate visualization and hence injury to surrounding structures should 
be kept in mind. Retroperitoneal hematoma, injury to organs and nerve roots are potential 
complications, but systematic review and meta-analysis search demonstrate that no block-
related complications occurred, especially with Posterior approach of QLB, and with 
experienced hands. Long experience in using ultrasound for nerves block for QLB and TAP 
block of the investigators. Infection at the site of injection; full aseptic precautions are used 
to avoid infection or abscess formation. 
 
b. What possible discomfort, inconvenience and possible side effects, costs may be 
experienced by the subjects? 

DAE Research & Ethics Form / March 2020 
9 
Lower extremity weakness has been reported with quadratus lumborum block leading to 
delay in mobilization. Local anesthetic distribution to the nerve roots or branches of lumbar 
plexus through spread in paravertebral spaces or via transversalis fascia is likely responsible 
for weakness of hip flexors (psoas and iliacus) and knee extensors (quadriceps).  Quadriceps 
weakness was reported to be most associated with anterior quadratus lumborum block, but 
less by posterior and lateral approaches respectively. 
c. Plans for reporting unanticipated problems or study deviations. 
 
D2.   Describe the probable benefits for: 
 
a. The participant. Detail compensation for participants and any proposed reductions or 
penalties for not completing the protocol. 
No additional risk or involvement required from the participant; hence no 
compensation is proposed. 
  
b. The institution(s). Hospital. 
Improve patient’s satisfaction, and reduce postoperative opioids consumption, as well as 
postoperative chronic pain incidence. 
            Getting involved in research will benefit hospital’s aim to become a center of    
excellence in research medicine 
c. Society, including the UAE as a country. 
Several studies have used different doses and concentrations of local anesthetics. However, 
a literature search identified no randomized controlled trials that evaluated the optimal 
concentration of local anesthetics used for QLB resulting in the best pain relief after 
caesarean section. This study will help to standardize postoperative analgesic protocol used 
for QLB after caesarean section. 
 
D3.  
Informed Consent 
 
a. What information will be given to subjects and how will it be given? Include copies of 
information letters.  
 
b. From whom and how will informed consent be ensured and obtained? 
The participant are the patients attend the pre‐assessment anesthetic clinic and are scheduled 
for elective caesarean section under spinal anesthesia. Information sheet about the study (in 
Arabic and English languages) will be given to the patients who fulfill the inclusion criteria 
for the study, the procedure will be explained, and all the questions will be answered. The 
consent form then asked to be signed. 
 
D4. 
Confidentiality 
 
a. How and where will the data obtained from the study be stored and secured? 
The study data will be collected and stored in one excel document that will be password 
encrypted. This document will be saved on the principle investigator’s personal computer 
which is password protected. Patients’ information such as MRN number and DOB, will be 
stored safely in the secured excel document. However, during statistical analysis, no 
identifying patient’s information will be included, and the results will be completely 
anonymous. There will be no sharing of information via email or between other devices. 

DAE Research & Ethics Form / March 2020 
10
 
b. How will respect for the patient’s rights (preservation of confidentiality, the possibility 
to withdraw without negative consequences etc.) be ensured?  
The participants will sign a consent stating. 
• 
The participation is voluntary, and participants are free to withdraw at any time of the 
study. 
• 
Withdrawal from the study will not adversely affect their management plan.  
• 
The study results will be completely anonymous, and all their information will be stored 
confidential and in a safe secured place. 
 
D5. 
Has this proposal received ethical approval from any other institution(s)? If yes, 
please provide name of institution(s) and a copy of approval document(s). 
 
No 
 
D6. 
How will you report back to the involved departments/units and to the Research      
Ethics Committee and the Research Review Committee? 
            Study results will be documented in an evaluation report, and a summary presentation will be 
prepared by the research team. 
 
E. 
BUDGET 
 
 
 
E1. 
Describe the envisaged expenses for the study in terms of personnel, 
 
supplies/Equipment, services, etc. 
 
We are performing QLB on most of our patients who are scheduled for caesarean   
section. 
            No additional expenses incurred for the study. 
       
 
E2. 
How are the expenses covered? Describe the funding of the project, including 
possible contributions from industry. Please attach copies of agreements made with 
commercial institutions. 
           Not applicable as no additional cost involved. 
       No commercial funding, all extra time is volunteer by the study group. 
 
F. 
ADDITIONAL COMMENTS AND INFORMATION 
 
     Support for this study was provided solely from institution and departmental resources. 
      Supports are provided from Research ethic committee and quality departments. 
 
 

DAE Research & Ethics Form / March 2020 
11
CHECK LIST FOR Submission of Application 
 
Requirements for approval of a project by DAE Research Ethics Committee 
 
 Documentation requirements for ethical application include: 
o Completed application form 
o Questionnaires  
o Consent form [sample enclosed] 
o Patient information sheets both in Arabic and English. 
o [Short CV relevant to the project (applicants outside DAE)  
 
 
 Requirements for a favorable opinion 
o See attached document 
 
 

DAE Research & Ethics Form / March 2020 
12
GUIDELINES FOR PARTICIPANT  
REQUIREMENTS FOR A FAVORABLE OPINIONi 
 
Before giving a favorable opinion, Al Ain Medical District Human Research Ethics Committee 
should be adequately reassured about the following issues, as applicable: 
 
1.1 
Scientific design and conduct of the study: 
 
a. 
The appropriateness of the study design in relation to the objectives of the study, the 
statistical methodology (including sample size calculation where appropriate) and the 
potential for reaching sound conclusions with the smallest number of research 
participants. 
 
b. 
The justification of predictable risks and inconveniences weighed against the 
anticipated benefits for the research participants, other present and future patients, and 
the concerned communities. 
 
c. 
The justification for use of control arms in trials, (whether placebo or active 
comparator), the randomization and binding process to be used as well as the methods 
used to provide allocation concealment, intention-to-treat analysis and sufficient follow 
up. 
 
d. 
Criteria for prematurely withdrawing research participants in trials. 
 
e. 
Criteria for suspending or terminating the research as a whole in trials. 
 
f. 
The adequacy of provisions made for monitoring and auditing the conduct of the 
research in trials, including the constitution of a data safety monitoring committee 
(DSMC). 
 
1.2 
Recruitment of research participants 
 
a. 
The characteristics of the population from which the research participants will be drawn 
(including gender, age, literacy, culture, economic status and ethnicity) and the 
justification for any decisions made in this respect. 
 
b. 
The means by which initial contact and recruitment is to be conducted. 
 
c. 
The means by which full information is to be conveyed to potential research 
participants or their representatives. 
 
d. 
Inclusion criteria for research participants. 
 
e. 
Exclusion criteria for research participants. 
 
1.3 
Care and protection of research participants 
 
a. 
The safety of any intervention to be used in the proposed research. 

DAE Research & Ethics Form / March 2020 
13
 
b. 
The suitability of the investigator(s)’s qualifications and experience for ensuring good 
conduct of the proposed study. 
 
c. 
Any plans to withdraw or withhold standard therapies or clinical management protocols 
for the purpose of the research, and the justification of such action. 
 
d. 
The health and social care to be provided to research participants during and after the 
course of the research. 
 
e. 
The adequacy of health care and social supervision and psychosocial support for the 
research participants. 
 
f. 
Steps to be taken if research participants voluntarily withdraw during the course of the 
research. 
 
g. 
The criteria for extended access to, the emergency use of, and/or the compassionate use 
of study products in trials. 
 
h. 
The arrangements, if appropriate, for informing the research participant’s general 
practitioner, including procedures for seeking the participant’s consent to do so. 
 
i. 
A description of any plans to make the study product available to the research 
participants following the research. 
 
j. 
A description of any financial costs to research participants. 
 
k. 
The rewards and compensations (if any) for research participants (including money, 
services and/or gifts). 
 
l. 
Whether there is provision in proportion to the risk for compensation/treatment in the 
case of injury/disability/death of a research participant attributable to participation in 
the research; the insurance and indemnity arrangements. 
 
m. 
The nature and size of any grants, payments or other reward to be made to any 
researchers or research hosts. 
 
n. 
Circumstances that might be lead to conflicts of interest that may affect the independent 
judgement of the researcher(s).                                    
 
1.4 
Protection of research participants’ confidentiality  
 
a. 
A description of the persons who will have access to personal data of the research 
participants, including medical records and biological samples. 
 
b. 
The measures taken to ensure the confidentiality and security of personal information 
concerning research participants. 
 
c. 
The extent to which the information will be anonymised. 

DAE Research & Ethics Form / March 2020 
14
 
d. 
How the data/samples will be obtained, and the purposes for which they will be used. 
 
e. 
How long the data/samples will be kept. 
 
f. 
To which countries, if any, the data/samples will be sent. 
 
g. 
The adequacy of the process for obtaining consent for the above. 
 
1.5 
Informed consent process 
 
a. 
A full description of the process for obtaining informed consent, including the 
identification of those responsible for obtaining consent, the timeframe in which it will 
occur, and the process for ensuring consent has not been withdrawn. 
 
b. 
The adequacy, completeness and understandability of written and oral information to be 
given to the research participants, and, when appropriate, their legally acceptable 
representatives. 
 
c. 
Clear justification for the intention to include the research individuals who cannot 
consent, and a full account of the arrangements for obtaining consent or authorization 
for the participation of such individuals. 
 
d. 
Assurances that research participants will receive information that becomes available 
during the course of the research relevant to their participation (including their rights, 
safety and well-being). 
 
e. 
The provisions made for receiving and responding to queries and complaints from 
research participants or their representatives during the course of a research project. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
                                               

DAE Research & Ethics Form / March 2020 
15