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CTRI Number  CTRI/2020/03/024315 [Registered on: 27/03/2020] Trial Registered Prospectively
Last Modified On: 15/10/2021
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
Modification(s)  
To study pain relief after nerve block given post caesarean delivery .  
Scientific Title of Study   To study the efficacy of ultrasound guided Quadratus Lumborum block for post operative analgesia after lower segment caesarean section:a randomised prospective controlled 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 Pragya Shukla 
Designation  JR 
Affiliation  SGPGIMS 
Address  Department of Anaesthesiology, sgpgims Lucknow
Department of Anaesthesiology, sgpgims Lucknow
Lucknow
UTTAR PRADESH
226014
India 
Phone  7599296498  
Fax    
Email  pragyashuklakgmc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sandeep Sahu 
Designation  Additional professor 
Affiliation  SGPGIMS 
Address  Department of Anaesthesiology, sgpgims Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904598  
Fax    
Email  drsandeepsahu09@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sandeep Sahu 
Designation  Additional professor 
Affiliation  SGPGIMS 
Address  Department of Anaesthesiology, sgpgims Lucknow

Lucknow
UTTAR PRADESH
226014
India 
Phone  8004904598  
Fax    
Email  drsandeepsahu9@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  Dr Sandeep Sahu 
Address  Additional Professor, Department of Anaesthesiology, sgpgims, lucknow 
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 Sandeep Sahu  SGPGI ,LUCKNOW  department of maternal and reproductive health, second floor, PMSSY BLOCK, SGPGIMS,LUCKNOW 226014
Lucknow
UTTAR PRADESH 
8004904598

drsandeepsahu09@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethical committee,sgpgi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O754||Other complications of obstetric surgery and procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Quadratus Lumboum Block Group  Quadratus Lumborum block will be given in pregnant females after their lower segmant caesarean section. 
Comparator Agent  Wound Infiltration Group  Lower Segmant caesarean section wound will be infiltrated by same drug (as used in nerve block ) in patients after lower segment caesarean section surgery 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Adult female patients, ASA physical status I or II, with normal singleton pregnancy with a gestation of atleast 37 weeks who are scheduled for lower segment caesarean section under spinal anaesthesia will be included in the study. 
 
ExclusionCriteria 
Details  Patient refusal to partipate, coagulation disorders, signs of local or systemic infection, , patients with acute or chronic renal disease, spinal deformities, ASA grade 3 or 4 ,patients who used anticoagulants or were unable to comprehend or use the verbal rating pain scoring system or PCA pump . 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of USG guided Quadratus lumborum block (USG-QL) in reducing pain (static and dynamic) after LSCS  At 0 (zero) hours,4 hours,8 hours,12 hours,16 hours,20 hours and finally 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
1.Duration of analgesia in both groups,
2.Pain- by NRS score
3.Total analgesic consumption : measure 24 hr fentanyl demands and doses delivered by patient controlled analgesia(PCA)
4.Rescue analgesia : Injection Tramadol ( need, freq, quantity)
5.Satisfaction score: of patient
6.Complications : Incidence of Post operative nausea and vomiting ,level of sedation
7.To study the side effects and complications related to ultrasound guided quadratus lumborum block if any.
 
At 0 (zero) hours,4 hours,8 hours,12 hours,16 hours,20 hours and finally 24 hours 
 
Target Sample Size
Modification(s)  
Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "67"
Final Enrollment numbers achieved (India)="67" 
Phase of Trial
Modification(s)  
N/A 
Date of First Enrollment (India)   01/04/2020 
Date of Study Completion (India) 23/01/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   1. Kerai S, Saxena KN. Quadratus lumborum block for post-caesarean analgesia. Indian J Anaesth. 2017;61(4):364. doi:10.4103/ija.IJA_220_17 2. Nair A. Bilateral quadratus lumborum block for post-caesarean analgesia. Indian J Anaesth. 2017;61(4):362–363. doi:10.4103/ija.IJA_204_17 3. Sebbag I, Qasem F, Dhir S. Bloqueio do quadrado lombar guiado por ultrassom para analgesia pós cesariana: série de casos [Ultrasound guided quadratus lumborum block for analgesia after cesarean delivery: case series]. Rev Bras Anestesiol. 2017;67(4):418–421. doi:10.1016/j.bjan.2017.03.002 4. Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015;32(11):812–818. doi:10.1097/EJA.0000000000000299  
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
As pain is ranked highest among undesirable clinical outcomes associated with caesarean section and it interferes with both mother and new born care ,so we are doing this study to see the role of levobupivacaine (which is used world wide for nerve blockade ) and efficacy in reducing post operative analgesia after caesarean section and we will also compare it with wound infiltration of same drug.Although IT and epidural morphine remain the most popular form of acute pain control for Caesarean pain, more than 70% of patients require additional analgesia. Furthermore, the sideeffect profile should not be underestimated; as many as 87% of patients experience pruritus and up to 70% experience urinary retention. Nausea and vomiting have also been well-established side effects, leading to significant discomfort for a new mother trying to provide acute infant care. Although nonsteroidal anti-inflammatory drugs and acetaminophen are helpful opioid-sparing multimodal adjuncts, the role of regional anaesthesia in improving Caesarean pain requires additional exploration. An IV PCA pump with demand dosing of opioids (fentanyl) provides effective pain relief after LSCS surgeries. However there are very limited studies on the assessment of analgesic efficacy and side effects of Quadratus lumborum block after caesarean section , as it confer major advantage over IVPCA alone because the regimen including background infusion increases total drug dosage and side effects without significantly improving analgesic efficacy. So, we designed a prospective, randomized study to evaluate the efficacy and side effects of quadratus lumborum block with levoboupivacaine in patients undergoing LSCS and taking patients with wound infiltration with same drug and as control group .We wish to compare between these two groups and conclude the best amongst the two. Following approval by the Institutional Ethics Committee, study would be completed in the period of 2 years. After taking written and informed consent from the patient, this study would be conducted in adult pregnant females with normal singleton pregnancy with a gestation of atleast 37 weeks undergoing lscs under spinal anaesthesia. Spinal anaesthesia will be administered with 27 G pencil tip needle, 2.0 ml heavy bupivacaine Patients will be immediately placed in supine position and spinal anaesthesia will be considered successful when a bilateral block to T6 , assessed by loss of cold(spirit swab) and touch (blunt pain ) discrimination will be established While in supine position ,patients will receive bilateral QLB at the end of surgrey .QLB will be performed under USG guidance using broad band (5-8MHz) convex probe .After cleaning abdomen with povidone iodine ,probe will be placed at ASIS and moved cranially until three abdominal wall muscles are clearly identified The needle will be inserted in plane from medial(anterior)to lateral (posterior).The optimal point of injection will be determined using hydrodissection . Assessment of pain will be done by a 11 point numerical rating scale (NRS); 0= no pain, 10 = worst imaginable pain.
Patients who met the inclusion criteria during the pre-anaesthetic check up will be randomly assigned into two equal groups of 30 each with the help of a computer generated table of random numbers; each group will receive post operative iv pca infusion with a solution containing 10 μg ml-1 fentanyl at a rate required by the patient.
QL BLOCK Group: USG guided QL block  with 0.25 % 20 -30ml levobupivacaine and IV Paracetamol 8 hourly, up to 24 hours postoperatively.  
 
 CONTROL Group:    wound infiltration with 0.25 % 20-30 ml levobupivacine  and IV Paracetamol , 8 hourly up to 24 hours postoperatively. 
  
 
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