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CTRI Number  CTRI/2024/01/061837 [Registered on: 25/01/2024] Trial Registered Prospectively
Last Modified On: 13/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   study comparing the efficacy of post operative pain control with use of injection in spinal fluid with pain control drug vs usg guided regional pain control injection near surgical site in muscles in LSCS patients operated under spinal anaesthesia 
Scientific Title of Study   A Prospective randomised comparative study evaluating the analgesic efficacy of intrathecal fentanyl, ultrasound guided TAP block AND ultrasound guided Quadratus Lumborum Plane block in patients undergoing lower segment cesarean 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 Apoorva Naik 
Designation  Consultant anaesthesiologist  
Affiliation  Karwar medical college 
Address  Main OT complex, ground floor, District Hospital attached to Karwar institute of medical sciences, Karwar 581301

Uttara Kannada
KARNATAKA
581301
India 
Phone  9972195395  
Fax  -  
Email  anaik868@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Apoorva Naik 
Designation  Consultant anaesthesiologist  
Affiliation  Karwar medical college 
Address  Main OT complex, ground floor, District Hospital attached to Karwar institute of medical sciences, Karwar 581301

Uttara Kannada
KARNATAKA
581301
India 
Phone  9972195395  
Fax  -  
Email  anaik868@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Apoorva Naik 
Designation  Consultant anaesthesiologist  
Affiliation  Karwar medical college 
Address  Main OT complex, ground floor, District Hospital attached to Karwar institute of medical sciences, Karwar 581301

Uttara Kannada
KARNATAKA
581301
India 
Phone  9972195395  
Fax  -  
Email  anaik868@gmail.com  
 
Source of Monetary or Material Support  
District hospital attached to Karwar institute of medical sciences, MG Road, Karwar, Uttar Kannada district , Karnataka -581301 
 
Primary Sponsor  
Name  Dr Apoorva 
Address  District hospital, Karwar 
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 Apoorva  Karwar District hospital   Ground floor main OT complex, District hospital attached to Karwar institute of medical sciences, Karwar 581301
Uttara Kannada
KARNATAKA 		 9972195395

anaik868@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
karwar institute of medical sciences institutional ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intrathecal fentanyl versus tap block versus qlblock  Intrathecal fentanyl 25mcg during spinal anaesthesia using 2ml of bupivacaine hyperbaric versus usg guided tap block using 0.25% local anaesthetic bupivacaine 20 ml each on either side or ql block with 0.25% local anaesthetic bupivacaine 20ml on either side at end of LSCS and efficacy observed for 24 hours. One time intervention lasting about 5 minutes . 
Comparator Agent  Usg guided TAP or QL block after LSCS before shifting out of OT  Usg guided TAP block bilateral or usg guided QL block bilateral using 0.25% bupivacaine 20 mL on either side at the end of surgery and the intervention is single time lasting about 5 minutes and its effect observed for 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  64.00 Year(s)
Gender  Female 
Details  Asa2 pregnant patients 
 
ExclusionCriteria 
Details  Co morbid illnesses, contraindication spinal
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Post op analgesia using the VAS score for pain and if more than 4 rescue analgesics given IV   Post op analgesia at 0,1,2,4,6,12,18,24 hours using VAS score 
 
Secondary Outcome  
Outcome  TimePoints 
Post operative nausea & vomiting, post operative sedation of patient APGAR score of newborn born out of LSCS  Post operative nausea, vomiting & sedation noted at 0,1,2,6,12,18,24 hours. APGAR SCORE of baby at 0,1,3,5 minutes after birth. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   30/01/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  30/01/2024 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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   We have decided to analyse the efficacy of post-operative analgesia with intrathecal fentanyl when compared to USG guided TAP and QL blocks. Post operative analgesia plays an important role in speedy post surgical recovery , wound healing, early mobilisation and improving overall patient well being and surgical outcome. We are of the opinion that USG guided blocks are much safer and better options for post operative analgesia when compared to intrathecal route and have no side effects. Duration of analgesia is much longer not needing any other intravenous pain control measures. Hence with this hypothesis we have decided to analyse their efficacy in post LSCS patients by this comparative study. 
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