| CTRI Number |
CTRI/2024/07/071473 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare between ultrasound guided erector spinae plane block and oblique subcostal transversus plane block pain control in patients after laparoscopic cholecystectomy |
|
Scientific Title of Study
|
Comparative study of the efficacy of ultrasound guided erector spinae plane block and oblique subcostal transversus abdominis plane block for post operative analgesia after 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 Subu Kobing |
| Designation |
Post graduate trainee |
| Affiliation |
RIMS Imphal |
| Address |
Department of Anaesthesiology
RIMS
Imphal A sector Naharlagun, Near Rajdhani petrol pump
Distt Papumpare
State Arunachal Pradesh Imphal West MANIPUR 795004 India |
| Phone |
6909021993 |
| Fax |
|
| Email |
kobingsubu@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Kh Maniram Singh |
| Designation |
Professor |
| Affiliation |
RIMS Imphal |
| Address |
Department of Anaesthesiology
RIMS
Imphal Department of Anaesthesiology
RIMS
Imphal Imphal West MANIPUR 795004 India |
| Phone |
8259055986 |
| Fax |
|
| Email |
drmram6@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Subu Kobing |
| Designation |
Post graduate trainee |
| Affiliation |
RIMS Imphal |
| Address |
Department of Anaesthesiology
RIMS
Imphal A sector Naharlagun
Near Rajdhani petrol pump
Distt Papumpare
State Arunachal Pradesh Imphal West MANIPUR 795004 India |
| Phone |
6909021993 |
| Fax |
|
| Email |
kobingsubu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal
Manipur
795004
India |
|
|
Primary Sponsor
|
| Name |
SUBU KOBING |
| Address |
Regional Institute of Medical Sciences
Imphal
Manipur
795004
India |
| 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 SUBU KOBING |
Regional Institute of Medical Sciences Imphal West,Manipur |
Elective surgery Operation theatre complex (OT number 1 to 8) Department of Anaesthesiology
Regional Institute of Medical Sciences
Imphal West
Manipur
795004
India Imphal West MANIPUR |
6909021993
kobingsubu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board,Regional Institute of Medical Sciences,Imphal,Manipur |
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 |
NIL |
NIL |
| Comparator Agent |
Ultrasound-guided Erector Spinae Plane block |
Study Participants will be divided into two groups. Intervention Group A will be given Erector Spinae Plane Block at the level of T9 vertebra with 40ml of 0.25% Levobupivacaine after Laparoscopic Cholecystectomy and patients will be followed up for 24 hours after the intervention. |
| Intervention |
Ultrasound-guided Oblique Subcostal Transversus Abdominis Plane Block |
Study Participants will be divided into two groups. Intervention Group B will be given Oblique Subcostal Transversus Abdominis Plane Block with 40ml of 0.25% Levobupivacaine just below the costal margin after Laparoscopic Cholecystectomy and the patient will be followed up for 24 hours after the intervention |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age 18-70 years with ASA(American Society of Anaesthesiologists)Grade 1 and Grade 2
2.Patients with BMI between 18-30 |
|
| ExclusionCriteria |
| Details |
1.Patients refusal
2.Patients with known allergy to local anaesthesia
3.Patients with bleeding diathesis,presence of severe kidney,hepatic disease,on anticoagulants,pre-existing cardiovascular disease,chronic opioid consumption,severe or advanced psychiatric illness.
4.Patients with previous upper abdominal surgery,any deformity in spine
5.Patients with infection at the regional block site |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate for pain using Numerical Rating Score(NRS) |
Outcome will be assesed at 0 hour,3rd,6th,9th,12th,18th and 24th hour after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate total analgesic consumption and time to first rescue analgesia and postoperative nausea and vomiting |
Outcome will be assesed from the time of intervention and data will be collected at the end of 24 hour |
|
|
Target Sample Size
|
Total Sample Size="86" Sample Size from India="86"
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)
|
10/08/2024 |
| 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="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
|
Laparoscopic Cholecystectomy is a minimally invasive surgery, which is the procedure of choice for the majority of patients with gallbladder pathologies. Intraoperative access is provided with small keyhole entries on abdominal wall. Laparoscopic Cholecystectomy causes moderate to severe postoperative pain which has different components; incisional pain from the trocar site(somatic pain),and local visceral pain(deep abdominal pain).Many patients also suffer from shoulder pain which is due to subdiaphragmatic irritation, transmitted by phrenic nerve referred to C4 dermatome. Multimodal approaches with NSAIDS, dexamethasone, gabapentinoids, opioids, local anesthetic infiltration to port sites, epidural analgesia have been tried to attenuate postoperative pain after Laparoscopic Cholecystectomy. Inadequate postoperative pain control has many consequences ,including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, increased healthcare costs etc. Hence, adequate Postoperative Pain Management(POPM) should be major issue and challenge for the anesthesiologists. Ultrasound-guided oblique subcostal transversus abdominis plane block(OSTAP) blocks somatic pain fibers and the deeper fibers of the anterior and lateral cutaneous branches of the 9th to 11th thoracic intercostal nerves. Ultrasound-guided erector spinae plane block (ESPB) is a relatively new technique used for analgesia. It targets the ventral rami, dorsal rami, and rami communicantes of the spinal nerves and thus results in the blockage of both somatic and visceral pain. Our study aimed to compare these two blocks using low concentration of Local anesthetic (0.25% Levobupivacaine). |