Comparison Between Retrolaminar Block Combined With Erector Spinae Plane Block, and Erector Spinae Plane Block Alone for Post-thoracotomy Pain
Phase: NA
Conditions: Post-thoracotomy Pain Syndrome
Sponsor: Cairo University

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  26/7/2022 
    
 
Comparison between Retrolaminar block combined with 
Erector Spinae Plane block, and Erector Spinae Plane block 
alone for post-thoracotomy pain 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents طه 
Title 
Page 3 
Investigators  
Page 3 
Introduction  
Page 4 
Aim of the work 
Page 5 
Objectives  
Page 5 
Hypothesis 
Page 5 
Ethical considerations   
Page 5 
Methodology  
 
I. 
Study design 
Page 5 
II. 
Study setting and location  
Page 5 
III. 
Study population  
Page 5 
IV. 
Eligibility criteria  
 Inclusion criteria 
 Exclusion criteria 
Page 6 
V. 
Study procedures  
 Randomization  
 Study protocol 
 Measured parameters  
 
Page 6 
Page 6, 7, 8  
Page 8 
VI. 
Study outcomes  
 Primary outcomes 
 Secondary outcomes  
Page 9 
Statistical analysis 
 Sample size 
 Statistical analysis 
Page 10 
References  
Page 11, 12 
 
 

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Study Title 
 
Comparison between Retrolaminar block combined with Erector Spinae 
Plane block, and Erector Spinae Plane block alone for post-thoracotomy 
pain. 
 
Investigators 
 
Candidate Details 
Name: Ahmed Osama Mohamed 
Degree: Resident of anesthesiology and surgical ICU and pain 
management 
Phone No: 01272297412-01014429299 
Email: ahmedomoh630@gmail.com 
Principle Investigator 
  
Name: Prof. Dr. Hisham Khedr  
Phone No: 01001622640 
Email: hkhishamkhedr@gmail.com 
Professor of anesthesiology and surgical ICU and pain management 
Co-investigator (A): 
Name Ass. Prof. Dr. Pierre Zarif 
Phone No: 01223647115 
Email: pierrezarif@gmail.com 
Assistant Professor of anesthesiology and surgical ICU and pain 
management 
Co-investigator (B): 
Name: Dr. Sherief Mamdouh 
Phone No: 01141235049 
Email: S25041989@hotmail.com 
Lecturer of anesthesiology and surgical ICU and pain management

 
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Introduction 
Post-thoracotomy pain is a challenging clinical problem that may be 
associated with increased morbidity and mortality. (1) 
The surgical incision produces post-thoracotomy pain (PTP) via damage to 
the ribs and intercostal nerves, inflammation of the chest wall, pleura or pulmonary 
parenchyma cutting, and placement of the intercostal chest tube. Acute PTP inhibits 
the ability to breathe and cough normally. Numerous analgesic techniques are used 
to relieve PTP, including systemic opioids, regional techniques (such as 
paravertebral nerve blockade, intercostal nerve blockade, intrapleural analgesia, and 
epidural opioids with or without local analgesia), cryo-analgesia, and transcutaneous 
electrical nerve stimulation (TENS). (2) 
Emerging research has shown that the novel erector spinae plane block 
(ESPB) can be employed as a simple and safe alternative analgesic technique for 
acute post-surgical, post-traumatic, and chronic neuropathic thoracic pain in adults. 
(3) 
 ESPB was first reported in 2016 for ipsilateral thoracic analgesia. (4)It was 
found to be a safe and effective block that can be performed by an emergency 
physician in the emergency department setting for addressing acute pain due to 
multiple rib fractures. (5) 
Retrolaminar block (RLB) was first reported in 2006 as an alternative 
approach to PVB. RLB is performed with US imaging or the landmark technique. 
(4) The efficacy of continuous RLB has been reported for breast cancer surgery  . (6) 
However, the efficacy of ESPB has been described in a greater number of 
clinical reports than has RLB: a rib fracture, breast surgery, thoracoscopic 
surgery, lumbar spinal surgery, and laparoscopic abdominal surgery. In 
contrast to RLB, most of the literature on ESPB reported the use of the single-
shot technique (80.2%). The local anesthetic was postulated to infiltrate the 
ventral and dorsal rami of the spinal nerve. However, Ueshima et al. reported 
that ESPB could not provide adequate analgesia of the anterior branch of the 
intercostal nerve. (4) 
The rationale of the study is that to the best of our knowledge each of ESPB 
and RLB has limitations regarding sensory block and distribution so our hypothesis 
is combining both will provide more solid block regarding sensory distribution, time 
interval of the block efficacy, and postoperative morphine consumption in patients 
undergoing thoracic surgeries. 

 
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 Few studies evaluated the efficacy of ultrasound (US) guided erector spinae 
plane block on post-thoracotomy analgesia, however for the best of our knowledge 
no one compared the effect of ultrasound (US) guided retrolaminar block combined 
with erector spinae plane block and ultrasound (US) guided erector spinae plane 
block alone in patients undergoing thoracic surgeries. 
Aim of the work 
This work aims to investigate whether adding the RLB to the ESPB would 
intensify the block decreasing the primitive opioid consumption. Using   
20ml for ESPB compared to 10ml ESPB adding to 10ml RLB. 
 
 
 
 
Objectives: 
 
To assess the efficacy of ultrasound (US) guided Retrolaminar block 
combined with Erector Spinae plane block compared to ultrasound (US) guided solo 
Erector Spinae plane block for thoracotomy pain. 
Hypothesis: 
We hypothesize that ultrasound (US) guided Retrolaminar block combined 
with Erector Spinae plane block will provide more post-operative analgesia than 
ultrasound (US) guided Erector Spinae plane block alone for thoracotomy pain. 
 Ethical Considerations 
The study will be conducted after taking approval from the research ethical 
committee; Informed consent will be obtained from the patients. Documentation of 
any complications -if present- will be documented. 
Methodology 
 
I. 
Study design  
This is a randomized controlled, double-blind study. 
II. 
Study setting and location  
The study will be conducted at Kasr Al-Ainy Hospital, Faculty of Medicine, 
Cairo University, cardiothoracic unit. 
III. Study population: 
Patient undergoing open thoracic surgery through a posterolateral thoracotomy. 

 
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IV.    Eligibility Criteria 
1. Inclusion criteria  
 Age from 18–65 years. 
 body mass index (BMI) ranged between 20 and 40 kg/m2 
 ASA I, II patients undergoing open thoracic surgery through a 
posterolateral thoracotomy 
2. Exclusion criteria  
 Patient refusal. 
 Sensitivity or contraindication to local anesthetic drugs. 
 History of psychological disorders and/or chronic pain. 
 Localized infection at the site of the block. 
 Coagulopathies, patients on anticoagulants and antiplatelets, and 
significant liver or renal insufficiency. 
V   Study Procedures  
 
1. Randomization  
Patients will be allocated in a parallel manner into two equal groups: Group 1 
(ESPB (control group): (n = 15) patients will receive preoperative US-guided ESPB 
on the operated side by 20 ml bupivacaine 0.25%. Group 2: US-guided ESPB with 
10 ml bupivacaine 0.25% + the US-guided retrolaminar block 10 ml bupivacaine 
0.25% group: (n = 15) on the operated side. 
Randomization will be accomplished through the use of computer-generated 
random numbers and closed opaque envelopes. Another anesthesiologist who will 
not be involved in the other parts of the study will open the envelopes to enroll 
patients. and both patients and outcome assessors will be blinded to the assignment 
of groups. 
1.  Study Protocol  
Preoperative assessment of all patients comprised of history taking, clinical 
examination, laboratory testing (complete blood count, kidney function tests, liver 
function 
tests, 
prothrombin 
time, 
and 
partial 
thromboplastin 
time), 
electrocardiogram, and chest X-ray. The study protocol will be explained to the 
patients, and their consent will be obtained. All patients will be made familiar with 
the use of the pain score; visual analog scale score (VAS) identifying 0 as no pain 
and ten as the worst possible pain. 
The patients will be continuously monitored in the holding room for heart rate, 
blood pressure, and oxygen saturation (baseline values). An intravenous (IV) 18-

 
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gauge cannula will be inserted. Midazolam 2mg boluses IV will be administered for 
each patient. Patients will receive US-guided ESPB and US-guided ESPB + US-
guided Retrolaminar plain block before induction of GA. 
US-guided ESPB Blocks will be performed with a US machine (Philips HD 
11xe) equipped with an HFL38X high-frequency linear transducer (13–16 MHz). 
With patients in a sitting position, the transducer will be positioned longitudinally 3 
cm lateral to the T5 spinous process. The trapezius, rhomboid major, and erector 
spinal muscles will be revealed superficial to the shadow of the hyperechoic 
transverse process. Then, 3 ml lidocaine 2% will be used to anesthetize the skin. 
Using a 20-gauge block needle inserted in-plane in a cephalad-to-caudad orientation 
to position the tip into the fascial plane on the deep (anterior) side of the erector 
spinae muscle, 20 ml bupivacaine 0.25% will be injected. The needle tip’s placement 
was confirmed by observable fluid spread lifting the erector spinae muscle away 
from the transverse process’s bony shadow. (2)  
 
For the retrolaminar block, an in-plane technique under ultrasound guidance 
will be used to advance the needle towards the posterior surface of the T5 lamina in 
a cephalic to caudal direction until contact with the lamina will be made. After 
confirming contact, the correct spread will be verified by injecting 1.0–2.0 ml of 
saline to create a plane of hypoechoic space on the posterior surface of the T5 
lamina,(7) and 10 ml bupivacaine 0.25% will be injected.  
 The block success will be assessed by a blind observer unrelated to data 
collection. The presence of the cold sensation in T1-T8 dermatomes in the blocked 
side after 30 minutes indicated a failed block, and the patient will be excluded . (9) 
  
GA will be induced for both groups using IV fentanyl 2 μg/kg and propofol 2 mg/kg. 
Tracheal intubation will be facilitated by Atracurium 0.5 mg/kg and will be done 
either by a left-sided double-lumen endobronchial tube (Mallinckrodt’s 35 to 41 F 
according to patient size), or single lumen ETT and a fiberoptic bronchoscope will 
be used to ensure the correct position of the tube. The tidal volume will be adjusted 
to be 6–8 ml/kg, and the respiratory rate will be adjusted to keep the end-tidal 
CO2 between 30 and 40 mmHg.(2) 
Anesthesia will be maintained with inhaled Isoflurane with MAC 1-1.5 in 
oxygen-enriched air (Fio2 will be adjusted to keep peripheral O2 saturation ≥90%) 
and top-up doses of Atracurium (0.1 mg/kg) IV will be administered as required. 
Ringer acetate will be infused to replace their fluid deficit, maintenance, and losses. 
(2)0 

 
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      Additional bolus doses of fentanyl one µg/kg IV will be given if the mean arterial 
blood pressure (MAP) or heart rate (HR) rises above 20% of baseline levels after 
exclusion of all causes leads to an increase of both HR and MAP as awareness and 
fading of neuromuscular blockade.  
One reading of MAP and HR will be taken before induction of GA to be 
defined as a baseline reading and then will be recorded immediately before surgical 
incision and at 30 min intervals intraoperatively. Hypotension will be treated with 
100 ml 0.9% normal saline bolus and 5 mg ephedrine IV in incremental doses to 
maintain MAP above 70 mmHg. Bradycardia (HR <60) will be treated with 0.1 
mg/Kg atropine IV.(2) 
At the end of the surgery, the residual neuromuscular blockade will be 
reversed using 0.07 mg/kg Prostigmin IV, and extubation will be performed after 
complete recovery of the airway reflexes. 
Then, patients will be transferred to the post-operative care unit (PACU) and 
will be observed for two hours. Following that, the patients will be transferred to a 
ward and given 1 g of acetaminophen IV every 8 hours, ketorolac tromethamine 
30mg IM/12h as 2 components of multimodal anesthesia regimen for postoperative 
pain control. (10) 
VAS (at rest and cough), MAP, and HR will be noted immediately on arrival 
to PACU (0 h) and at 2, 4, 6, 12,18, and 24 h postoperatively. Rescue analgesia will 
be provided in the form of IV morphine 3 mg boluses if VAS >3. The time to first 
request rescue analgesia and the total morphine administered during the first 24-hour 
postoperative will be recorded.  
Patient satisfaction (satisfied or not satisfied) will be recorded 24 hours 
postoperative. Adverse events will be reported (PONV, hypotension, bradycardia, 
excessive sedation, and hematoma). 
Measured Parameters: 
 Hemodynamics including MAP and HR throughout the surgery  
 VAS (at rest and cough), MAP, and HR will be noted immediately on arrival to 
ICU (0 h) and at 2, 4, 6, 12,18, and 24 h postoperatively figure (1).
 

 
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Figure1:Visual analog score (8) 
 Post-operative Total amount of morphine consumption in the first 24-hour. 
 Incidence of complications, such as nerve injury, hematoma formation, and 
severe hypotension will be noted. 
VI. 
Study outcomes 
1. Primary outcome  
  Total amount of morphine consumption in the first 24-hour postoperative in 
the two groups.  
2. Secondary outcome(s). 
 Pain score according to VAS score at 30min, 2h, 4h, 8h, 12h, 24h 
postoperative. 
 Heart rate and MAP at 0 , 15min, 30min, 45min, 60min, 90min, 120min, then 
every 1h intraoperative. 
 First request of analgesia postoperative. 
 Opioid requirements intraoperatively. 
 Incidence of complications as hypotension, bradycardia, postoperative 
nausea, vomiting (PONV) and pruritis. 
 

 
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Sample size 
Statistical Analysis 
1) Sample size  
Power analysis was performed using G power software on the level of total 
amount of morphine consumption in the first 24-hour postoperative as it is the 
primary outcome in the current study using a student t-test. 
A previous study showed that total amount of morphine consumption in the 
first 24-hour postoperative , mean(SD) after ESPB was 8=52(4=29) mg. (9) 
Based on assumption that a 50% difference between groups is a clinically 
significant difference and for a power of 0.95 and alpha error of 0.05. 
A minimum of 16 patients was calculated for each group. The sample size will 
be increased to 18 for each group to compensate for possible dropouts. 
  
2) Statistical analysis  
 Microsoft excel 2013 will be used for data entry and the statistical package 
for social science (SPSS version 24) will be used for data analysis.  
 Simple descriptive statistics (arithmetic mean and standard deviation) will be 
used for the summary of normal quantitative data (median and interquartile 
range) for a summary of abnormal quantitative data and frequencies will be 
used for qualitative data. 
 Bivariate relationship will be displayed in cross-tabulations and a Comparison 
of proportions will be performed using the chi-square and Fisher’s exact tests 
where appropriate. 
 T-test and post-hook tests will be used to compare normally distributed 
quantitative data and Kruskal-Wallis for skewed data. 
 P value will be calculated to assess statistical significance, a value less than 
0.05 will be considered statistically significant.

 
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References 
1. Dokhan AL, Abd Elaziz ME, Gaballah KM. Efficacy of paravertebral block 
analgesia for post-thoracotomy pain control. Journal of the Egyptian Society of 
Cardio-Thoracic Surgery. 2016 May 1;24(1):65-72. 
2. Elshal MM, Gamal RM, Ahmed AM, Gouda NM, Abdelhaq MM. Efficacy of 
adding dexmedetomidine as an adjuvant with bupivacaine in ultrasound-guided 
erector spinae plane block for post-thoracotomy pain: Randomized controlled 
study: Dexmedetomidine as an adjuvant in ESPB for PTP. Egyptian Journal of 
Anaesthesia. 2021 Jan 1;37(1):425-31. 
3. Fang B, Wang Z, Huang X. Ultrasound-guided preoperative single-dose erector 
spinae plane block provides comparable analgesia to thoracic paravertebral block 
following thoracotomy: a single-center randomized controlled double-blind 
study. Annals of translational medicine. 2019 Apr;7(8). 
4. Onishi E, Toda N, Kameyama Y, Yamauchi M. Comparison of clinical efficacy 
and anatomical investigation between retrolaminar block and erector spinae plane 
block. BioMed research international. 2019 Mar 28;2019. 
5. Kumar G, Kumar Bhoi S, Sinha TP, Paul S. Erector spinae plane block for 
multiple rib fracture done by an Emergency Physician: A case series. 
Australasian Journal of Ultrasound in Medicine. 2021 Feb;24(1):58-62. 
6. Zeballos JL, Voscopoulos C, Kapottos M, Janfaza D, Vlassakov K. Ultrasound‐
guided retrolaminar paravertebral block. Anesthesia. 2013 Jun;68(6):649-51. 
7. Yang HM, Choi YJ, Kwon HJ, O J, Cho TH, Kim SH. Comparison of injectate 
spread and nerve involvement between retrolaminar and erector spinae plane 
blocks in the thoracic region: a cadaveric study. Anesthesia. 2018 
Oct;73(10):1244-50. 
8. Shukla RH, Nemade SV, Shinde KJ. Comparison of visual analog scale (VAS) 
and the Nasal Obstruction Symptom Evaluation (NOSE) score in the evaluation 
of post septoplasty patients. World Journal of Otorhinolaryngology-Head and 
Neck Surgery. 2020 Mar 1;6(1):53-8. 
9. HASSAN, Mohamed Elsayed; WADOD, Mohamed Abd Alfattah. Serratus 
anterior plane block and erector spinae plane block in postoperative analgesia in 
thoracotomy: A randomized controlled study. Indian Journal of Anesthesia, 
2022, 66.2: 119. 
 

 
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10.  Sobhy MG, Abd El-Hamid AM, Elbarbary DH, Elmeliegy MF. Ultrasound-
guided erector spinae block for postoperative analgesia in thoracotomy patients: 
a prospective, randomized, observer-blind, controlled clinical trial. Ain-Shams 
J Anaesthesiol, 2020:12(1).