| CTRI Number |
CTRI/2025/04/085237 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing post-operative pain control of ultrasound-guided bilateral modified thoracoabdominal nerves block through perichondrial approach and ultrasound-guided bilateral external oblique intercoastal plane block in patients undergoing laparoscopic cholecystectomy : A Randomized Clinical Trial |
|
Scientific Title of Study
|
Comparison of Post-operative Analgesic Efficacy of the Ultrasound-guided Bilateral Modified Thoracoabdominal Nerves Block through Perichondrial Approach (M-TAPA) and Ultrasound-guided Bilateral External Oblique Intercoastal Plane Block (EOIPB) in Patients Undergoing Laparoscopic Cholecystectomy : A Randomized Clinical 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 |
Dr Abid K Dodamani |
| Designation |
Post Graduate Trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur, India - 795004
Imphal West
MANIPUR
795004
India |
| Phone |
7259252091 |
| Fax |
|
| Email |
kdabid105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
L Chaoba Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal West, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur -795004
Imphal West
MANIPUR
795004
India |
| Phone |
9436022521 |
| Fax |
|
| Email |
drchaoba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
L Chaoba Singh |
| Designation |
Professor |
| Affiliation |
Regional Institute of Medical Sciences, Imphal West, Manipur |
| Address |
Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur -795004
Imphal West
MANIPUR
795004
India |
| Phone |
9436022521 |
| Fax |
|
| Email |
drchaoba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur 795004 |
|
|
Primary Sponsor
|
| Name |
Abid K Dodamani |
| Address |
Regional Institute of Medical Sciences, Imphal West, Manipur 795004 |
| Type of Sponsor |
Other [Self] |
|
|
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 Abid K Dodamani |
Regional Institute of Medical Sciences |
Elective surgery Operative theatre complex (OT 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur
Imphal West
MANIPUR |
7259252091
kdabid105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, RIMS |
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 |
| Intervention |
External Oblique Intercostal Plane Block |
Study participants will be randomized into two groups. Interventional group receiving external oblique intercostal plane block after induction and before surgery. |
| Comparator Agent |
Modified thoraco-abdominal nerves block through perichondrial approach |
Study participants will be randomized into two groups. Comparator group receiving modified thoraco-abdominal nerves block through perichondrial approach after induction and before surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of age group 18-65 years.
2) Patients of American Society of Anaesthesiologists (ASA) physical status I or II |
|
| ExclusionCriteria |
| Details |
1) Patients with active block injection site infections.
2) Patients on anticoagulants or clinically significant coagulopathy.
3) Patients with history of hypersensitivity to amide group of local anaesthetic agents.
4) Patients receiving opioids for chronic analgesic therapy.
5) Patients with preoperative use of any pain reliever within 24 hours.
6) Patients with alcohol use or drug use (daily usage for the past 1 month).
7) Patients with body mass index (BMI) more than 30kgm-2 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total analgesic consumption in the first 24 hours of the postoperative period |
1st 24 hours of post-operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparing the VRS scores at rest and movement in the first 24 hours of the postoperative period |
VRS scores will be assessed at rest and movement in the first 24 hours of the postoperative period |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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)
|
30/04/2025 |
| 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 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 is one of the most frequently performed procedures and has a short postoperative hospital stay. Even though laparoscopic cholecystectomy results in less postoperative pain than open cholecystectomy, severe pain is a common complaint, particularly in the first 24 hours. The effectiveness of ultrasound-guided inter-fascial plane blocks has recently come to the fore in the field of regional anaesthesia and pain management. This study will be a randomized double-blinded clinical study to compare the postoperative analgesic efficacy of ultrasound guided bilateral modified thoracoabdominal nerve block through perichondrial approach and ultrasound-guided bilateral external oblique intercostal plane block in patients undergoing elective laparoscopic cholecystectomy. After approval from the research ethics board of RIMS, Imphal, a total number of 58 patients (18-65 years, ASA I and II, BMI < 30kg/m2) will be randomized into one of the two groups (n=29) after taking written informed consent from the patients. Following anaesthesia induction and patient intubation, group M-TAPA will receive a modified thoracoabdominal nerve block through a perichondrial approach with 20ml of inj. Ropivacaine 0.25% bilaterally and group EOIPB will receive an external oblique intercostal plane blocks with 20ml of Inj. Ropivacaine 0.25% bilaterally. Postoperatively patients will be shifted to PACU, where the assessment of VRS scores, will be recorded at designated periods. Total analgesic consumption up to 24 hours, and time of first rescue analgesia will be recorded. Data will be recorded in a proforma tabulated in the EXCEL software and analyzed using IBM SPSS Version 26 software. A p-value of less than 0.05 will be taken as statistically significant. |