| CTRI Number |
CTRI/2024/06/069184 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A research study comparing pain relief effectiveness between two drugs nalbuphine versus ketamine used along with levobupivacaine in subcostal transversus abdominis plane block during laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
Comparison of analgesic efficacy between Nalbuphine versus Ketamine as an adjunct to Levobupivacaine in USG guided Subcostal Transversus Abdominis Plane block in Laparoscopic Cholecystectomy. |
| 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. Sourav Acharya |
| Designation |
Junior Resident PG Student |
| Affiliation |
AIIMS Raebareli |
| Address |
Department of Anaesthesia
2nd floor
Main hospital building
AIIMS Raebareli
Dalmau road Munshiganj
Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
9937635454 |
| Fax |
|
| Email |
sourav1acharya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Surendra Kumar Jangid |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Department of Anaesthesia
2nd floor
Main hospital building
AIIMS Raebareli
Dalmau Road Munshiganj
Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8560919243 |
| Fax |
|
| Email |
dr.skjangid@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Surendra Kumar Jangid |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Raebareli |
| Address |
Department of Anaesthesia
2nd floor
Main hospital building
AIIMS Raebareli
Dalmau Road Munshiganj
Raebareli
Rae Bareli
UTTAR PRADESH
229405
India |
| Phone |
8560919243 |
| Fax |
|
| Email |
dr.skjangid@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Raebareli, Uttar Pradesh, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Raebareli |
| Address |
Department of Anaesthesia
2nd floor
Main hospital building
AIIMS Raebareli
Dalmau Road Munshiganj
Raebareli Uttar Pradesh |
| Type of Sponsor |
Government medical college |
|
|
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 Sourav Acharya |
AIIMS Raebareli |
Department of Anaesthesia
2nd floor
Main hospital building
AIIMS Raebareli
Dalmau road Munshiganj
Raebareli Uttar Pradesh
Rae Bareli
UTTAR PRADESH |
9937635454
sourav1acharya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, AIIMS RAEBARELI |
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 |
LK Group - Patient allotted group LK will receive 18 ml of 0.5% Levobupivacaine & 2 ml Ketamine as study drug in Subcostal TAP block. |
USG guided Subcostal TAP block with Levobupivacaine with Ketamine on either side. The study drug will be prepared using 18ml of 0.5% levobupivacaine with 2 mL Ketamine.
Following skin disinfection, high frequency linear transducer probe will be positioned alongside the lower margin of rib cage & maneuvered. The target for needle insertion will be the fascial plane between the posterior rectus sheath & transversus abdominis muscle. After satisfactory imaging, a 22G, 10-cm sterile nerve stimulator puncture needle of will be inserted above the rectus abdominis muscle close to midline & advanced from lateral to medial in an in-plane technique. The end point of the injection is the spread of local anesthetic in the fascial plane between the posterior rectus sheath & the anterior margins of transversus abdominis muscle. Hydro dissection using 2 ml of normal saline will be used to identify the correct plane, following which 20 ml of the prepared study drug will be deposited, and the block will be repeated on the opposite side. Postoperative pain will be assessed using the Numerical Rating Scale [NRS] on a scale from 0 [no pain] to 10 [worst possible pain]. NRS scores will be noted from the PACU, and then at 30 minutes, 1, 2, 4, 6, 12, & 24 hours postoperatively. NRS score 4 will be considered significant.
Duration 24 hours |
| Comparator Agent |
LN Group - Patient allotted group LN will receive 18 ml of 0.5% Levobupivacaine & 2 ml Nalbuphine as study drug in Subcostal TAP block. |
USG guided Subcostal TAP block with Levobupivacaine with Nalbuphine on either side. The study drug will be prepared using 18ml of 0.5% levobupivacaine with 2 mL Nalbuphine.
Following skin disinfection, high frequency linear transducer probe will be positioned alongside the lower margin of rib cage & maneuvered. The target for needle insertion will be the fascial plane between the posterior rectus sheath & transversus abdominis muscle. After satisfactory imaging, a 22G, 10-cm sterile nerve stimulator puncture needle of will be inserted above the rectus abdominis muscle close to midline & advanced from lateral to medial in an in-plane technique. The end point of the injection is the spread of local anesthetic in the fascial plane between the posterior rectus sheath & the anterior margins of transversus abdominis muscle. Hydro dissection using 2 ml of normal saline will be used to identify the correct plane, following which 20 ml of the prepared study drug will be deposited, and the block will be repeated on the opposite side. Postoperative pain will be assessed using the Numerical Rating Scale [NRS] on a scale from 0 [no pain] to 10 [worst possible pain]. NRS scores will be noted from the PACU, and then at 30 minutes, 1, 2, 4, 6, 12, & 24 hours postoperatively. NRS score 4 will be considered significant.
Duration 24 hours |
| Intervention |
SUBCOSTAL TRANSVERSUS ABDOMINIS PLANE BLOCK |
The enrolled patients will be randomly allocated via computer generated randomization into two groups. Patients will receive USG guided Subcostal transversus abdominis plane block with study drug on either side by an experienced anesthesiologist not involved in the assessment of post-operative pain based on allotment from sealed envelopes. Post-operative pain will be assessed using the Numerical Rating scale (NRS) on a scale from 0 (no pain) to 10 (worst pain). NRS scores will be noted from the PACU, and then at 30 minutes, 1, 2, 4, 6, 12, & 24 hours postoperatively. NRS score 4 will be considered significant. Intravenous Tramadol 1 mg/kg in 100ml NS infusion will be given as rescue analgesia whenever a patient complained of pain and the NRS score 4. The time of the first request for rescue analgesia and total Tramadol consumption in the first 24 hours postoperative period will be recorded.
Duration - 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patient of ASA grade 1 and 2 aged from 18-60 years with BMI of 18.5 to 29.9 kg/m2 who are undergoing elective Laparoscopic Cholecystectomy surgery will be included. |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Pregnancy
3. BMI above 30 kg/m2
4. Cerebrovascular disease
5. Systemic infection
6. Inability to understand the study protocol
7. Allergy to local anesthetics
8. Psychiatric condition that may affect patient evaluation
9. Coagulopathy
10. Intraoperative major events (cardiovascular, neurological)
11. Infection at site of injection
12. Any Hepatic disorder
13. Any Renal disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To compare the duration of analgesia between the groups after administration of Subcostal TAP block.
-To assess the time until 1st dose of rescue analgesia between the groups.
-To quantify the amount of rescue analgesia required 24 hours post the administration of block.
|
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -To compare the hemodynamic parameters between the groups. |
24 hours |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
08/07/2024 |
| 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="6"
Days="1" |
|
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
|
This study is a randomized control, double blinded trial comparing the analgesic efficacy of nalbuphine versus ketamine as an adjunct to levobupivacaine in USG guided subcostal transversus abdominis plane block in laparoscopic cholecystectomy that is being conducted in AIIMS Raebareli. The primary outcome is to compare the duration of analgesia, the time until rescue analgesia & the amount of rescue analgesia between the two subgroups & to compare any hemodynamic parametric differences between the two groups. |