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CTRI Number  CTRI/2021/03/032403 [Registered on: 30/03/2021] Trial Registered Prospectively
Last Modified On: 26/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to see the analgesic effect of Posterior quadratus lumborum block after cesarean section under spinal anaesthesia.  
Scientific Title of Study   Analgesic efficacy of ultrasound guided posterior quadratus lumborum block after cesarean section under spinal anaesthesia- a comparative intervention study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ankita Bodhankar 
Designation  PG Student 
Affiliation   
Address  Department of Anaesthesiology, Pt. J. N. M. Medical College, Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  8103268885  
Fax    
Email  ankitab0810@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr P J Shah 
Designation  Professor  
Affiliation   
Address  Department of Anaesthesiology, Pt. J. N. M. Medical College, Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  9827276620  
Fax    
Email  prati_jain@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr P J Shah 
Designation  Professor  
Affiliation   
Address  Department of Anaesthesiology, Pt. J. N. M. Medical College, Raipur

Raipur
CHHATTISGARH
492001
India 
Phone  9827276620  
Fax    
Email  prati_jain@rediffmail.com  
 
Source of Monetary or Material Support  
Dr Bhimrao Ambedkar Memorial Hospital, Raipur 
 
Primary Sponsor  
Name  Dr P J Shah 
Address  Department of Anaesthesiology, Pt. J. N. M. Medical College,Raipur, Chhattisgarh 
Type of Sponsor  Other [Self] 
 
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 Ankita Bodhankar  Dr Bhimrao Ambedkar Hospital  Department of Anaesthesiology, Pt JNM medical college, Raipur
Raipur
CHHATTISGARH 		 8103268885

ankitab0810@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Pt. J. N. M. Medical College, Raipur (C.G.)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bilateral posterior quadratus lumborum block  After full aseptic precautions and skin preparations, posterior quadratus block will be performed under ultrasound guidance using linear 7 to 12 MHz ultrasound transducer probe. Probe will be horizontally placed on the anterior-superior iliac crest, and moved in the cranial direction until the external oblique, internal oblique and transversus abdominis will be observed in the form of three layers on the lateral abdominal wall. Then, the probe will be directed posteriorly, and the QL muscle and thoracolumbar fascia will be observed in the area where the three muscular layer ends. A 20-gauge epidural needle/spinal needle will be directed to the posterior of the QL muscle and 20 ml of 0.25% Bupivacaine will be injected bilaterally. 
Comparator Agent  Intravenous tramadol  100mg of intravenous tramadol to be given immediately after the surgery 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. ASA Physical status II-III
2. Elective Caesarean section
3. BMI: 18-30 Kg/m2
4. Height: 140-180 cm
5. Singleton pregnancy with gestational age of atleast 37 weeks.
 
 
ExclusionCriteria 
Details  1. Refuse to participate
2. Allergy to study drug.
3. On any analgesic and anti-inflammatory drugs.
4. Patients with coagulation abnormalities.
5. Infection, lump or deformity at the injection site.
6. Intraoperative requirement of second analgesic.
7. Patients with alcoholic liver disease.
8. Pregnancy induced hypertension.
9. Gestational diabetes mellitus.
10. Spine deformity.
11. Opioid abuse.
12. Patient on Mono Amino Oxidase (MAO) inhibitors.

 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Tramadol consumption in first 24 hours post-operatively.  Tramadol consumption in first 24 hours post-operatively. 
 
Secondary Outcome  
Outcome  TimePoints 
NRS (Numerical Rating Scale) score for pain on movement and at rest postoperatively immediately after recovery, at 1 hr, 3hr, 12hr and 24hr. Duration of analgesia. Post- operative nausea. Patient satisfaction. Time of ambulation.   First 24 hours post- opeartively. 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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   N/A 
Date of First Enrollment (India)   31/03/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a prospective, randomised, single-blind study to analyse the analgesic efficacy of ultrasound guided posterior quadratus lumborum block after caesarean section spinal anaesthesia by comparing with  intravenous(IV) tramadol in 96 parturients of age group 18 to 40 years with ASA physical status grade II- III. It will be conducted at single centre in India. The primary outcome is to calculate Tramadol consumption in first 24 hours post- operatively. 
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