| CTRI Number |
CTRI/2024/03/063802 [Registered on: 07/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of MTAPA and OSTAP( two techniques of nerve blocks),to reduce pain, after laparoscopic gallbladder surgeries . |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) VS oblique subcostal transversus abdominis plane block(OSTAP) in laproscopic cholecystectomy -A randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rahul Katyal |
| Designation |
Post diploma DNB trainee |
| Affiliation |
Northern Railway Central Hospital |
| Address |
Department of anaesthesiology, Northern railway central hospital, Basant Lane, New delhi
New Delhi
Central DELHI 110055 India |
| Phone |
8360129948 |
| Fax |
|
| Email |
katyalrahul6@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Sushil krishnan |
| Designation |
Assistant Chief Health Director |
| Affiliation |
Northern Railway Central Hospital |
| Address |
Department of anaesthesiology, Northern Railway Central Hospital, Basant Lane, New delhi
Central DELHI 110055 India |
| Phone |
9717630552 |
| Fax |
|
| Email |
dr.sushilkrishnan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sushil krishnan |
| Designation |
Assistant chief health director |
| Affiliation |
Northern Railway Central Hospital, |
| Address |
Department of anaesthesiology, Northern Railway Central Hospital, Basant Lane, New Delhi
Central DELHI 110055 India |
| Phone |
9717630552 |
| Fax |
|
| Email |
dr.sushilkrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Northern railway central hospital, basant lane, new delhi |
|
|
Primary Sponsor
|
| Name |
Northern railway central hospital |
| Address |
Northern railway central hospital, basant lane, new delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rahul katyal |
Department of anaesthesiology, Northern Railway Central Hospital, Basant Lane, New Delhi |
Northern railway central hospital, Basant lane New Delhi
DELHI Central DELHI |
8360129948
katyalrahul6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee, northern railway central hospital, IEC-NRCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
oblique subcostal [OSTAP] block |
Ultrasound guided oblique subcostal [OSTAP] block using 0.5ml/kg of 0.2% Ropivacaine |
| Intervention |
ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) |
ultrasound guided modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) using 0.5ml/kg of 0.2% Ropivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 -75 years old, with American Society of Anaesthesiologists Physical Status grades [ASA] 1-3, scheduled for elective laparascopic cholecystectomy. |
|
| ExclusionCriteria |
| Details |
Known allergy or intolerance to injection Ropivacaine.Infection at the injection site of the block.Opioid consumption in last 24 hours. Coagulopathy.Known case of Psychiatric illness.Body mass index (BMI) ≥ 40kg /m2. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the 24 hour cumulative post-operative analgesic consumption [Tramadol] between the M-TAPA block, and the OSTAP block after laparascopic cholecystectomy . |
Comparison of total tramadol consumption in 24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NRS pain score |
30min 1 hour 2 hour 4 hour 8hour 24 hour |
| Time to first rescue analgesia |
Time taken to give first rescue analgesia |
| Comparison of QoR - 15 scale between the two groups |
24 hours post operative |
Comparison of thoracoabdominal areas with sensory block(T3 -L1)
|
2 Hours following surgery |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/03/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Laparoscopic cholecystectomy leads to somatic pain from the supraumbilical abdominal area and also visceral pain due to pneumoperitoneum and surgical manipulation.Pain managment in these patients is very important for enhanced recovery after surgery.Ultrasoundguidance and anatomic studies have led to the description of many new interfascial plane blocks.One of the most commonly used blocks is oblique transverse abdominisplane block[OSTAP] to relief post operative pain relief in laparoscopic abdominal surgeries.The thoracoabdominalnerves block through perichondrial approach[M-TAPA] is one of the newer blocks that is used nowadays for postoperative analgesia in laparoscopic abdominal surgeries. Early studies seem to indicate that M-TAPA hasadvantage over OSTAP. We will be conducting a double blinded, randomized control trial to compare the analgesic efficacy of ultrasound guided modified thoracoabdominal nerve block through perichondrial approach versus oblique subcostaltransversus abdominis plane block for laparoscopic cholecystectomy. Total of 60 patients will be randomly allocated into two equal groups of 30 patients each.The M-TAPA or OSTAP Blocks will be administered following general anesthesia with endotracheal intubation by the standard institutional protocol. We will note the 24 hour post-operative analgesic consumption [Tramadol ] ; the time of first rescue analgesic administration, and the NRS pain scale at 30 min ; 1 hour ; 2 hour ; 4 hour ; 8 hour and 24 hour will be noted .QoR-15 questionnaire scores both before and after the operation will recorded.Comparison of thoracoabdominal areas(T3-L1) with sensory block 2hours following surgery will be noted. |