| CTRI Number |
CTRI/2025/12/099175 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| 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 the effect of Tramadol versus Nalbuphine as adjuvants to Ropivacaine in transversus abdominis plane block for post-operative analgesia. |
|
Scientific Title of Study
|
A prospective, randomized study to compare the efficacy of Tramadol versus Nalbuphine as adjuvants to Ropivacaine in transversus abdominis plane block for post-operative analgesia in patients undergoing elective abdominal hysterectomy under spinal anesthesia. |
| 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 Shirali Deliwala |
| Designation |
PG student |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9714130502 |
| Fax |
|
| Email |
shiralideliwala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Patel |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jatin Patel |
| Designation |
Professor |
| Affiliation |
Smt. Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9879368363 |
| Fax |
|
| Email |
dr_jatinpatel@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Wagodhia ,
Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Center |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760 India |
| 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 |
| Dr Jatin Patel |
Dhiraj Hospital |
2nd Floor,General ot
complex,Anesthesia
Department,Dhiraj
hospital,Smt. Bhikiben
Kanjibhai Shah Medical
Institute and Research
Centre ,Sumandeep
vidyapeeth Wagodhia ,
Pipariya, Vadodara Wagodhia
, Pipariya, Vadodara, Gujarat - 391760
Vadodara
GUJARAT
Vadodara
GUJARAT |
9879368363
dr_jatinpatel@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Committee |
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 |
Inj Nabluphine + Inj ropivacaine |
Inj. Ropivacaine (0.2%) 40ml + Inj. Nalbuphine
0.2mg/kg, total drug will be diluted upto 50ml using normal saline and
25ml drug is given on each side bilaterally in transverse abdominus plane block for post operative analgesia in patients undergoing elective abdominal hysterectomy, under spinal anaesthesia |
| Intervention |
Inj tramadol + inj ropivacaine |
Inj. Ropivacaine (0.2%) 40ml + Inj. Tramadol
1mg/kg, total drug will be diluted upto 50ml using normal saline and 25ml
drug is given on each side bilaterally in transverse abdominus plane block for post operative analgesia in patients undergoing elective abdominal hysterectomy, under spinal anaesthesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving consent
Patient with asa grade 1,2
Patient posted for elective abdominal hysterectomy surgery under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
Patient not giving consent
Patient with asa grade 3,4,5
Patient who is having comorbidities like diabetes and hypertension |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of tramadol vs nalbuphine as an adjuvant to ropivacaine in transverse abdominis plane block |
0 to 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time at which rescue analgesia is given and post operative hemodynamic response |
0 to 24 hours |
|
|
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)
|
30/12/2025 |
| 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 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
|
Elective abdominal hysterectomy often results in significant postoperative pain, making effective analgesia essential for recovery. Regional anesthesia, particularly spinal anesthesia and the transversus abdominis plane (TAP) block, offers advantages such as reduced systemic drug use, fewer side effects, and improved postoperative comfort. TAP block provides analgesia by depositing local anesthetics in the neurofascial plane to block T7–L1 nerves. Ropivacaine is preferred for its safety and selective sensory block. Adjuvants like tramadol and nalbuphine enhance and prolong analgesia with fewer adverse effects. This study compares their effectiveness in postoperative pain control, hemodynamic stability, and sedation in abdominal hysterectomy patients. |