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CTRI Number  CTRI/2024/04/065566 [Registered on: 12/04/2024] Trial Registered Prospectively
Last Modified On: 10/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study to compare two different types of block for post surgery pain relief after cesarean section 
Scientific Title of Study   Comparison of postoperative analgesia for patients undergoing cesarean section with ultrasound-guided quadratus lumborum block-2 vs quadratus lumborum block-3 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GMCH/IEC/2023/257  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jasmine 
Designation  Postgraduate  
Affiliation  Government medical college and hospital Chandigarh 
Address  Department of Anaesthesiology and Critical care Fifth Floor D-block Government medical college and hospital Chandigarh 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  7526839775  
Fax    
Email  jasmine1singla@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sukanya Mitra 
Designation  Professor 
Affiliation  Government medical college and hospital Chandigarh 
Address  Department of Anaesthesiology and Critical care Fifth Floor D-block Government medical college and hospital Chandigarh 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121521  
Fax    
Email  drsmitra12@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sukanya Mitra 
Designation  Professor 
Affiliation  Government medical college and hospital Chandigarh 
Address  Department of Anaesthesiology and Critical care Fifth Floor D-block Government medical college and hospital Chandigarh 160030 India

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121521  
Fax    
Email  drsmitra12@yahoo.com  
 
Source of Monetary or Material Support  
Government medical college and hospital,Chandigarh, India 160030 
 
Primary Sponsor  
Name  Government medical college and hospital Chandigarh 
Address  fifth floor D block Government Medical college and hospital Chandigarh 160030 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jasmine  Government Medical college and hospital  Gynaecology Operation theater A block level 3, Area 35, Department of Gynaecology
Chandigarh
CHANDIGARH 
7526839775

jasmine1singla@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Government Medical college and hospital Chandigarh  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Pregnancy 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Quadratus lumborum block Type 2  Quadratus lumborum block Type 2 will be given at the end of cesarean section with 0.3 ml/kg of 0.25 % bupivacaine bilaterally in Group 1 patients and observed for 24 hours 
Comparator Agent  Quadratus lumborum block Type 3  Quadratus lumborum block Type 3 will be given at the end of cesarean section with 0.3 ml/kg of 0.25 % bupivacaine bilaterally in Group 2 patients and observed for 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Age 18 to 45 years, ASA II and III patients, pregnancy beyond 34 weeks, weight < 100 kg 
 
ExclusionCriteria 
Details  Allergy to local anesthetic drugs,obstetric complications (premature rupture of amniotic membranes, premature labor, eclampsia, antepartum hemorrhage, chorioamnionitis, HELLP syndrome), severe systemic diseases, coagulation abnormalities, patients with history of immunosuppression, Patients having intraoperative adverse events like hemorrhage, thromboembolism, bradycardia, allergic reaction etc., weight > 100 kg 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Time to first bolus of rescue analgesia postoperatively in both approaches of quadratus lumborum block   Patient assessed at 2, 4, 6, 12, 24 hours post block for pain score and rescue analgesia consumption 
 
Secondary Outcome  
Outcome  TimePoints 
Assess the static and dynamic pain scores post-operatively  Static and dynamic pain scores will be assessed post-operatively for 24 hours at regular time intervals by asking the patient to flex their legs and by turning to one side 
Total number of PCA demands  All the patients will receive PCA infusion maintained with boluses of fentanyl with 10 micrograms per ml. The patients will be provided with a remote controlled hand-held button and there will be a provision of patient controlled boluses of 1ml of 10 micrograms per ml of fentanyl, with a lockout interval of 10 min when needed. Total number of PCA demands will be noted 
No of PCA doses delivered  Actual doses of PCA are delivered within 24 hours of the operation 
Total amount of rescue analgesia consumed  Inj Diclofenac 75 mg iv will be used as rescue analgesia and total number of doses will be noted. 
Apgar score  Apgar scores at 1 minute and 5 minutes will be noted 
Time of completion of both types of QLB  Total time of completion of QLB 2 and QLB 3 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/04/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/04/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Pain following cesarean section included both somatic and visceral components and it is typically described as emanating from the abdominal wall incision. Intravenous NSAIDS combined with spinal and/or systemic opioids is usually employed for post-cesarean analgesia. Peripheral nerve blocks are the newer techniques in the multimodal analgesia approach and are associated with the least side effects. 

Quadratus lumborum block (QLB) is one such block for postoperative analgesia in cesarean patients. By dividing the area behind the quadratus lumborum muscle, USG QLB-2 refers to the administration of medication between the posterior side of the quadratus lumborum muscle and the medial lamina of the thoracolumbar fascia, which separates the posterior side of the quadratus lumborum from latissimus dorsi and the erector spinae muscles. USG QLB-3 pertains to the administration of medication at the front of the quadratus lumborum muscle, close to the point at which it is attached to the L4 vertebra’s transverse process. 

40 patients will be sampled by continuous sampling and will be allocated into groups by randomisation. 

GROUP 1 (n = 20): This group will receive USG QLB-2 

GROUP 2 (n = 20): This group will receive USG QLB-3 

All the patients will receive PCA infusion after positioning the patient supine. Maintenance of PCA will be started with boluses of fentanyl with 10 micrograms per ml. The patients will be provided with a remote controlled hand-held button and there will be a provision of patient controlled boluses of 1ml of 10 micrograms per ml of fentanyl, with a lockout interval of 10 min when needed. Inj Diclofenac 75 mg iv will be used as rescue analgesia Time of completion of both types of USG QLB, visual analogue scale at rest (VAS-R) and dynamic VAS (VAS-D) (0, no pain; 10 worst pain imaginable) at 0, 2, 6, 12, and 24 hours postoperatively, time for the first rescue analgesia, total number of PCA demands and total number of PCA demands within 24 hours of surgery, total doses of rescue analgesia used within 24 hours of surgery, apgar scores at 1 and 5 minutes and overall maternal satisfaction scores with nerve block (by asking the percentage of relief the patient felt on a 0-100 VAS scale) will be noted and documented


 
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