| CTRI Number |
CTRI/2025/02/080148 [Registered on: 07/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of relief of pain after operation between two types of regional anaesthesia technique (external oblique intercostal block versus oblique subcostal transversus abdominis plane block) for a special type of cut in the abdominal wall known as modified Makuuchi incision |
|
Scientific Title of Study
|
External oblique intercostal block vs Oblique subcostal transversus abdominis plane block for postoperative pain management in surgeries with modified Makuuchi incision- A Randomised Controlled Study (OBLIQUES |
| Trial Acronym |
- |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Angshuman Rudrapal |
| Designation |
Associate Consultant |
| Affiliation |
Tata Medical Center |
| Address |
Department of Onco-anaesthesia, Tata Medical Center, 14, Major Arterial Road, New Town, Kolkata-700160
-
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
7980006561 |
| Fax |
|
| Email |
angshunitya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Angshuman Rudrapal |
| Designation |
Associate Consultant |
| Affiliation |
Tata Medical Center |
| Address |
Department of Onco-anaesthesia, Tata Medical Center, 14, Major Arterial Road, New Town, Kolkata-700160
-
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
7980006561 |
| Fax |
|
| Email |
angshunitya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Angshuman Rudrapal |
| Designation |
Associate Consultant |
| Affiliation |
Tata Medical Center |
| Address |
Department of Onco-anaesthesia, Tata Medical Center, 14, Major Arterial Road, New Town, Kolkata-700160
-
North Twentyfour Parganas
WEST BENGAL
700160
India |
| Phone |
7980006561 |
| Fax |
|
| Email |
angshunitya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Onco-anaesthesia,Tata Medical Center, 14,Major Arterial Road, New Town, Kolkata-700160 |
|
|
Primary Sponsor
|
| Name |
Angshuman Rudrapal |
| Address |
Department of Onco-anaesthesia,
Tata Medical Center, 14,Major Arterial Road, New Town, Kolkata-700160 |
| 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 |
| Angshuman Rudrapal |
Tata Medical Center |
Operation theatre, Phase 1, Department of Onco-anaesthesia, Tata Medical Center, 14,Major Arterial Road, New Town, Kolkata-700160
North Twentyfour Parganas
WEST BENGAL |
7980006561
angshunitya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center- Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
External Oblique Intercostal (EOI) block |
Ultrasound guided identification of plane between External oblique and Intercostal muscles, just medial to anterior axillary line, will inject 15 ml 0.2% Ropivacaine and then introduce the catheter and inject 5 ml 0.2% Ropivacaine through the catheter. In the post operative period 0.2% Ropivacaine 5-6 ml/hour will be given as continuous infusion till 72 hours after surgery. And then the catheter will be removed. |
| Comparator Agent |
Oblique Subcostal TAP (OSTAP) block |
Ultrasound guided identification of plane between internal oblique and transversus abdominis muscle in subcostal area, will inject 15 ml 0.2% Ropivacaine and then introduce the catheter and inject 5 ml 0.2% Ropivacaine through the catheter. In the post operative period 0.2% Ropivacaine 5-6 ml/hour will be given as continuous infusion till 72 hours after surgery. And then the catheter will be removed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective abdominal surgeries with modified Makuuchi incision or reversed L- shaped incision.
2. American Society of Anaesthesiology Physical Score (ASA-PS) score of I - III
|
|
| ExclusionCriteria |
| Details |
Patients requiring postoperative mechanical ventilation.
Contraindications to spinal anaesthesia
Contraindications to study medication
Documented obstructive sleep apnea
Patients with life threatening arrhythmias
Patients with left ventricular ejection fraction less than 40%
Coagulopathy
Pre Existing neurological illness
Significant liver dysfunction (liver enzymes more than 3 times normal)
Significant renal dysfunction (creatinine more than 2 times normal)
Psychiatric illness
Opioid abuse
Patients receiving systemic opioids for chronic pain within last 30 days
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 24 hours intravenous morphine consumption in mg |
24 hours intravenous morphine consumption in mg |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. 48-hours and 72-hours intravenous morphine consumption in mg
2. QOR-15 score at postoperative day 1 and postoperative day 3
3. Postoperative rescue fentanyl requirements in mcg in the first 48 hours
4. Numeric Rating Scale (NRS)
5. Modified Ramsay Sedation Score
6. NRS on first ambulation
7. NRS on coughing
8. Postoperative respiratory depression
9. Time to enteric resumption
10. Time to ambulation
11. Time to flatus pass
12. Postoperative nausea and vomiting at the above mentioned time points
13. Postoperative pruritus at the above mentioned time points
14. Patient satisfaction score
15. Length of hospital stay
|
At rest on arrival at the ICU (T0); 3 hours (T1); 6 hours (T2); 12 hours (T3); 24 hours(T4); 48 hours (T5); 72 hours (T6)
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="2"
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
|
The modified Makuuchi incision involves a vertical midline cut that meets a horizontal incision at the umbilical level involving T6-T10 dermatomes. The horizontal incision takes a reversed L-shape, following the contour of the abdominal skinfold, ending at the midpoint between the lowest rib and the anterior superior iliac spine. This incision is often employed for upper abdominal surgeries like radical cholecystectomy, hepatectomy, Whipple’s procedure and radical nephrectomy. The institutional practice is to give bilateral oblique subcostal TAP block in these surgeries for postoperative analgesia as a part of an enhanced recovery protocol. This blocks the anterior cutaneous branches but spares the lateral cutaneous branches of T6-T10 intercostal nerves and hence does not cover the horizontal part of the incision. The external oblique intercostal block (EOIB),initially described by Elsharkawy et al, is a novel fascial plane block indicated for upper abdominal procedures. It blocks the anterior and lateral cutaneous branches of the T6–T10 intercostal nerves and can be performed easily under ultrasound guidance due to the superficial location of the fascial plane between the external oblique and intercostal muscles. To our knowledge, analgesic efficacy of EOIB vs OSTAP in surgeries involving modified Makuuchi incision has not been investigated yet in a randomised controlled trial. So, this single centre, randomised, double-blind controlled trial has been designed to investigate the analgesic efficacy of EOIB vs OSTAP in surgeries involving modified Makuuchi incision. 35 patients will be analysed in each group. Eligible patients undergoing elective abdominal surgeries with modified Makuuchi incision or reversed L- shaped incision will be included in our study. Our primary outcome is the 24 hour postoperative morphine consumption, while secondary outcomes include 48-hours and 72-hours intravenous morphine consumption in mg, QOR-15 score at postoperative day 1 and postoperative day 3, Postoperative rescue fentanyl requirements in mcg in the first 48 hours, Numeric Rating Scale (NRS) of static and dynamic pain, Modified Ramsay Sedation Score at various time intervals, complications like postoperative respiratory depression, PONV, pruritus, time to enteric resumption, ambulation and flatus pass, patient satisfaction score, length of hospital stay.
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