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CTRI Number  CTRI/2023/10/058525 [Registered on: 11/10/2023] Trial Registered Prospectively
Last Modified On: 28/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Other 
Public Title of Study   Comparison of post Caesarean pain relief using Subfascial and Extrafascial approach of Transmuscular Quadratus lumborum block. 
Scientific Title of Study   Comparison of post-operative analgesia using Subfascial and Extrafascial approach of Transmuscular Quadratus lumborum block after lower segment Caesarean section. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hemashree 
Designation  Post Graduate 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology, B L Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9868588596  
Fax    
Email  hemashree342@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mona Arya 
Designation  Professor 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology, B L Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9968604412  
Fax    
Email  monaarya@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Hemashree 
Designation  Post Graduate 
Affiliation  Maulana Azad Medical College 
Address  Department of Anaesthesiology, B L Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi

Central
DELHI
110002
India 
Phone  9868588596  
Fax    
Email  hemashree342@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College and associated Lok Nayak, G.N.E.C. and G.I.P.M.E.R. Hospitals, New Delhi-110002 
 
Primary Sponsor  
Name  Maulana Azad Medical College and associated Lok Nayak, G.N.E.C. and G.I.P.M.E.R. Hospitals 
Address  Maulana Azad Medical College and associated Lok Nayak, G.N.E.C. and G.I.P.M.E.R. Hospitals, Bahadur Shah Zafar Marg, New Delhi-110002 
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 Hemashree  Lok Nayak Hospital  Department of Anaesthesiology, 3rd floor, BL Taneja block, Maulana Azad Medical College and associated Lok Nayak, G.N.E.C and G.I.P.M.E.R. Hospitals, Bahadur Shah Zafar Marg, New Delhi
Central
DELHI 		 9868588596

hemashree342@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maulana Azad Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  GROUP I: Subfascial Approach of Transmuscular Quadrarus lumborum block  After completion of Caesarean section under sub-arachnoid block with 2-2.2 ml of 0.5% Bupivacaine(H), Transmuscular Quadratus lumborum block will be applied using a low frequency convex probe. A 21G 100mm ultrasound block needle will be introduced in the plane of ultrasound and advanced till it reaches anterior thoracic-lumbar fascia and 0.25% of Bupivacaine will be injected between Anterior thoracic-lumbar fascia and Quadratus lumborum muscle. Total duration of block is 10-15 minutes. 
Intervention  Group II: Extrafascial approach of Transmuscular Quadratus lumborum block  After completion of Caesarean section under sub-arachnoid block with 2-2.2 ml of 0.5% Bupivacaine(H), Transmuscular Quadratus lumborum block will be applied using a low frequency convex probe. A 21G 100mm ultrasound block needle will be introduced in the plane of ultrasound and advanced to puncture anterior thoracic-lumbar fascia and 0.25% of Bupivacaine will be injected between Psoas major muscle and Quadratus lumborum muscle.Total duration of block is 10-15 minutes. 
Comparator Agent  Post operative pain severity score at rest and at movement, to be assessed at 24 hours after surgery  Intensity of pain will be assessed using 11 point Numerical rating scale (NRS) ranging from "0"(no pain) to "10"(worst pain). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  1. Pregnant patients with age more than 18 years belonging to American Society of Anaesthesiologist(ASA) physical status-II
2. Singleton pregnancy
3. Period of gestation of at least 37 weeks
4. Parturients scheduled to undergo CS via Pfannenstiel incision 
 
ExclusionCriteria 
Details  1. Category I and II indications of CS
2. Coagulopathy
3. Local infection
4. History of allergy to any study drugs 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Post operative pain severity score at rest & at movement assessed at 24 hours after surgery   To be assessed at 24 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain severity   0 2 4 6 12 hours after surgery 
Time to request for first dose of rescue analgesia  First 24 hours after surgery 
Number of parturients requiring rescue analgesics  First 24 hours after surgery 
Total consumption of rescue analgesia   First 24 hours after surgery 
Lower limb weakness   6 & 12 hours post operatively 
Obstetric quality of recovery obsQR 11   24 hours after Caesarean section 
Number of parturients reporting pruritic, nausea & vomiting   24 hours after Caesarean section 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   16/10/2023 
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="1"
Months="0"
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   Ultrasound guided Transmuscular Quadratus lumborum (TQL) block is a relatively new fascial plane block where local anaesthetic is injected adjacent to Quadratus lumborum muscle with the goal of anaesthetising thoracolumbar nerves. Multiple studies have demonstrated that TQL block is effective for post operative analgesia in parturients. Inadequate pain relief and lower limb weakness adversely affects the recovery of parturients who underwent Caesarean section, thus we found it worthwhile to assess the subfascial and extrafascial approaches of TQL block for post operative analgesia in this patient population.
Pregnant patients of age more than 18 years scheduled to undergo elective Caesarean section under spinal anaesthesia, fulfilling the inclusion criteria will be recruited under the study. After randomisation using computer generated random number table, parturients will be allocated either Group-I (Subfascial) or Group II (Extrafascial). In the operating room, all standard monitors will be attached and lactated Ringer’s solution will be started after taking IV access. Under all aseptic conditions, Subarachnoid block will be given at L3-4 or L4-5 using Quincke needle with 2-2.2ml of 0.5% Bupivacaine(H). After adequate sensory block is achieved, surgery will be started and rest of the intra-operative management will be as per protocol. After completion of surgery, dressing will be applied and TQL block will be given. A low frequency (5-8MHz) broadband convex probe is placed transverse to flank between lower costal margin and iliac crest to provide a view of Shamrock sign(transverse process of L4 and the three muscles Quadratus lumborum, Psoas major and Erector spine). A 21G 100mm Ultrasound block needle will be introduced in the plane of ultrasound beam and advanced till the anterior thoracic-lumbar fascia(ATLF). In Group I, needle tip will not puncture ATLF and drug will be deposited between Quadratus lumborum muscle and ATLF. In Group II, needle tip will puncture ATLF and drug will be deposited between Psoas major and Quadratus lumborum. 20 ml of 0.25% Bupivacaine will be given on each side in both the groups. Patients will be observed for 10-15 minutes and then transferred to post anaesthesia care unit (PACU). All patients will receive Injection Paracetamol 1g IV in PACU and the 8 hourly for 24 hours for pain control. Pain severity will be assessed using Numerical rating scale (NRS) at 0, 2, 4, 6, 12 and 24 hours after surgery. If NRS>3, Injection Diclofenac 75mg will be slow IV as First Rescue Analgesic and if pain still persists, Injection Tramadol 50mg slow IV will be given(Second Rescue Analgesic). Data will be checked for normality. Normally distributed continuous variables will be compared using Unpaired t test while Mann Whitney U test will be used for variables that are not normally distributed. Categorical variables will be analyzed by Chi square test or Fischer’s test. Statistical analysis will be performed by SPSS program for Windows, version 25.0. 
 
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