| CTRI Number |
CTRI/2025/02/080918 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| 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
|
Comparing the effectiveness of regional nerve block under ultrasound guidance where one group of patients is given
Ketamine with bupivacaine and second
group is given dexamethasone with bupivacaine is patient undergoing total
laproscopic hysterectomy for post operative pain relief. |
|
Scientific Title of Study
|
Effectiveness of Ultrasound guided- Transverse Abdominis Plane Block using Ketamine with Bupivacaine versus Dexamethasone with Bupivacaine for post operative analgesia in patient undergoing Total Laproscopic Hysterectomy- a prospective randomized double blinded study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sara Zubair |
| Designation |
Post graduate student |
| Affiliation |
Institute of medical science and sum hospital |
| Address |
Department of Anesthesiology,IMS and SUM hospital,Siksha O Anusandhan University,Bhubaneswar,Khordha
Khordha
ORISSA
751003
India |
| Phone |
7738401492 |
| Fax |
|
| Email |
szubair17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Diptimayee Mallik |
| Designation |
Professor |
| Affiliation |
Institute of medical science and sum hospital |
| Address |
Department of Anesthesiology,IMS and SUM hospital,Siksha O Anusandhan University,Bhubaneswar,Khordha
Khordha
ORISSA
751003
India |
| Phone |
9861159151 |
| Fax |
|
| Email |
dr.diptimayee2010@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sara Zubair |
| Designation |
Post graduate student |
| Affiliation |
Institute of medical science and sum hospital |
| Address |
Department of Anesthesiology,IMS and SUM hospital,Siksha O Anusandhan University,Bhubaneswar,Khordha
Khordha
ORISSA
751003
India |
| Phone |
7738401492 |
| Fax |
|
| Email |
Szubair17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ims and Sum hospital, Kalinganagar,Bhubaneswar, Odisha, India , 751003 |
|
|
Primary Sponsor
|
| Name |
IMS and SUM hospital,Siksha O Anusandhan University,Bhubaneswar,Khordha |
| Address |
Institute of medical science and sum hospital, K8,Kalinganagar,Bhubaneswar,Odisha,751003 |
| Type of Sponsor |
Private 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 |
| Sara Zubair |
Ims and sum hospital |
Department of anaesthesia,Ims and SUM hospital,Siksha O Anusandhan university, k8 kalinganagar, Bhubaneswar, odisha , 751003
Khordha
ORISSA |
7738401492
szubair17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,IMS and SUM Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N998||Other intraoperative and postprocedural complications and disorders of genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
Injection Dexamethasone 8mg diluted with 5 ml normal saline as an additive give with 5ml of injection 0.5% bupivacaine (total volume of drug 10 ml on each side) in transverse abdominis plane block in patient undergoing total laproscopic hysterectomy gives prolonged and intense post operative pain relief.
Total volume of drug given is 20 ml in each patient. Route of administration is USG guided TAP block. |
| Intervention |
Ketamine |
Injection Ketamine (0.5 mg/kg) diluted with normal saline as an additive with 5 ml of injection 0.5% bupivacaine (total volume 10 on each side)given in transverse abdominis plane block in patient undergoing total laproscopic hysterectomy gives better post operative pain relieve and early ambulation. Total volume of drug used is 20 ml per patient. Route of administration USG guided TAP block. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Patients of age 30-70yrs
Patients under ASA I and ASA II
Patient undergoing elective total laproscopic hysterectomy
|
|
| ExclusionCriteria |
| Details |
Patient’s refusal to participate in the study
Patient taking anticoagulants
Have an allergy or contraindication to the drug used
Alcohol or drug abuse
Have infection near the block site
Have clinically significant neurological, cardiovascular, renal or hepatic disease.
ASA III-IV patients
Having mental disorder which interferes with visual analogue scale (VAS) evaluation were excluded from the study
|
|
|
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 |
To measure the duration of post operative analgesia and time required for primary dose of rescue analgesic after surgery.
To compare nad assess pain scores with bupivacaine plus ketamine versus bupivacaine plus dexamethasone post surgery surgery. |
Pain scores at 0, 2, 6, 8, 12, 24 hours post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Vital monitoring( heart rate, BP & spO2) during intra operative period.
Patient satisfaction score(excellent, good, fair, poor)
Side effects or any complications. |
Vital monitoring (HR, BP, spo2)at 0,5,10,15,30,60,90,120 minutes intra operatively post intubation.
Patient satisfaction score at 0, 2, 4,6, 12,24 hours post extubation. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
24/02/2025 |
| 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="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
|
This prospective, randomized, double-blind, comparative study will assess the efficacy of ultrasound-guided transverse abdominis plane (TAP) blocks with ketamine or dexamethasone as adjuvants to 0.5% bupivacaine in 60 patients undergoing total laparoscopic hysterectomy. The patients, aged 30–70 years (ASA grade I and II), will be divided into two groups of 30 each: - Group BD: TAP block with 0.5% bupivacaine + ketamine (0.5 mg/kg), total 20 mL.
- Group BK: TAP block with 0.5% bupivacaine + dexamethasone (8 mg), total 20 mL.
Procedure Overview: - Patients will be prepared with standard preoperative protocols, including IV access, standard monitors, and administration of premedications (ondansetron, pantoprazole, glycopyrrolate, midazolam, fentanyl, propofol, and vecuronium).
- After intubation, the TAP block will be performed bilaterally under ultrasound guidance by an experienced anesthesiologist.
- Surgery will proceed under general anesthesia with isoflurane, nitrous oxide, oxygen, and intermittent vecuronium. Pain management intraoperatively includes fentanyl boluses and diclofenac.
Postoperative Monitoring: - Patients will be monitored for pain using VAS scores and tramadol consumption.
- Ondansetron will be given for vomiting, and tramadol for pain (VAS > 4).
- At 24 hours, patients will rate pain relief satisfaction on a 4-point scale.
The study aims to compare pain relief, tramadol consumption, and patient satisfaction between the two groups. |