| CTRI Number |
CTRI/2025/08/093761 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To study the effect of addition of adjuvants- buprenorphine vs nalbuphine , to ropivacaine for giving spinal anaesthesia in below umbilicus surgeries |
|
Scientific Title of Study
|
EFFECT OF ADDITION OF BUPRENORPHINE VS NALBUPHINE TO 0.75 PERCENT HYPERBARIC ROPIVACAINE FOR THE SUBARACHNOID BLOCK IN INFRA-UMBILICAL SURGERIES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Roopkamal Kaur Dhami |
| Designation |
Pg student |
| Affiliation |
Adesh Institute Of Medical Sciences And Research |
| Address |
Room No.7 Ground floor,Adesh Institute of Medical sciences and research Department of Anaesthesiology & Intensive care Bathinda Punjab 151001 India
Hoshiarpur
PUNJAB
151001
India |
| Phone |
9877404570 |
| Fax |
|
| Email |
roopkamaldhami33@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mridul Madhav Panditrao |
| Designation |
head of department ,Department of Anaesthesiology and Intensive care, AIMSR, Bathinda |
| Affiliation |
Adesh Institute of Medical sciences and Research(AIMSR), Bathinda |
| Address |
Department of Anaesthesiology & Intensice care, Adesh Institute of
Medical sciences and Research Bathinda Bathinda Punjab 151001
India
Bathinda
PUNJAB
151001
India
Bathinda
PUNJAB
151001
India |
| Phone |
8699921884 |
| Fax |
|
| Email |
drmmprao1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mridul Madhav Panditrao |
| Designation |
head of department ,Department of Anaesthesiology and Intensive care, AIMSR, Bathinda |
| Affiliation |
Adesh Institute of Medical sciences and Research(AIMSR), Bathinda |
| Address |
Department of Anaesthesiology & Intensice care, Adesh Institute of
Medical sciences and Research Bathinda Bathinda Punjab 151001
India
Bathinda
PUNJAB
151001
India
Bathinda
PUNJAB
151001
India |
| Phone |
8699921884 |
| Fax |
|
| Email |
drmmprao1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Adesh Institute of medical Sciences and Research , Bathinda , Bhucho Kalan , pincode -151001 , Punjab , India |
|
|
Primary Sponsor
|
| Name |
Adesh University |
| Address |
Adesh Institute Of Medical Sciences And Research , Bathinda, pincode-151001, Punjab , 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 |
| Roopkamal Kaur Dhami |
Adesh Institute of medical sciences and Research, Bathinda |
Department of
Anaesthesiology and
intensive care, Adesh
institute of medical
sciences and research
(AIMSR) Bhucho Khurd
Barnala road Bathinda
151001
Bathinda
PUNJAB
Bathinda
PUNJAB |
9877404570
roopkamaldhami33@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Adesh University |
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 |
Nalbuphine with Ropivacaine vs buprenorphine with ropivacaine |
Comparison of addition of intrathecal 800 mcg of nalbuphine to ropivacaine vs addition of intrathecal 60 mcg of buprenorphine to 0.75 percent ropivacaine; for subarachnoid block in infra-umblical surgeries. To compare their effects on analgesia, sensory and motor blockade, hemodymanic parameters .
Total duration of study - 18 months |
| Intervention |
Subarachnoid block / spinal anaesthesia |
To see effect of addition of intrathecal buprenorphine vs nalbuphine to hyperbaric 0.75 percent ropivacaine ,on duration of analgesia , motor and sensory blockade, hemodynamic parameters and side effects if any . Total duration of study 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II patients of all genders
Patients posted for elective surgeries below umbilicus. |
|
| ExclusionCriteria |
| Details |
Contraindications to spinal anaesthesia (coagulopathy, local infection, severe
hypovolemia)
History of allergy to study medications
Significant cardiovascular, respiratory, renal, or hepatic dysfunction
Pregnancy or lactation
Patients on chronic analgesic therapy
Patients with psychiatric disorders
|
|
|
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 compare the characteristics of sensory and motor blockade as well as the total duration of
effective analgesia across all three groups. |
T0- 15min
T1- 30 min
T2-45 min
T3-60 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hemodynamic parameters (SBP, DBP, MAP, HR, SPO2 & RR) at baseline & at 5, 10,
15, 30, 60, 90, & 120 minutes after spinal anaesthesia.
|
Baseline
After preloading
After SAB
2 min
5 min
10 min |
| Sedation score using Ramsay sedation scale. |
Time Sedation Score
Baseline
15 min
30 min
60 min
90 min
120 min
End of surgery |
Incidence of side effects like nausea & vomiting (PONV), pruritus, respiratory
depression, hypotension, bradycardia. |
During perioperative period |
Patient satisfaction score on a 5-point Likert scale (1=very dissatisfied, 5=very satisfied)
using a specially designed questionnaire. |
Are you satisfied with Pre Anaesthetic Checkup visit?
1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very Satisfied
2. Was the advice given for pre-op preparation adequate ?
1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very
Satisfied
3. What was your experience in intra-op period (the spinal anaesthesia
experience)?
1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very
Satisfied
4. Was the pain relief adequate in immediate post-op period ?
1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very
Satisfied
5. What was your overall experience ?
1 Very Dissatisfied 2 Dissatisfied 3 - Neutral 4 Satisfied 5 Very
Satisfied |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
20/09/2025 |
| 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="1"
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
|
Subarachnoid block , also known as spinal anaesthesia , is a regional anaesthesia technique that involves the injection of a local anaesthetic into the subarachnoid space. This technique provides effective intraoperative anaesthesia and contributes significantly to postoperative pain management , which remains a critical component of enhanced recovery protocols in modern surgical practice. Ropivacaine has emerged as a suitable alternative local anaesthetic for subarachnoid blocks , offering reliable sensory and motor blockade with a favourable safety profile compared to other local anaesthetic. Buprenorphine , a partial mu receptor agonist and kappa receptor antagonist ,offers unique pharmacological advantages , high potency, long duration of action, less potential for respiratory depression , minimal dependency and abuse potential. Similarly nalbuphine a synthetic opioid agonist-antagonist acting primarily on kappa-receptors and partially inhibiting mu-receptors ,has gained attention for its ability to provide effective analgesia with potentially fewer side effects than pure mu-agonists. Recent studies have demonstrated the efficacy of both buprenorphine and nalbuphine as intrathecal adjuvants, but comparative studies directly evaluating their relative benefits in combination with ropivacaine are scarce. Given the evolving landscape of multi-modal analgesia and the move away from pure mu-agonists like fentanyl because of their side effects ,there is increasing interest in partial agonist drugs like nalbuphine and buprenorphine . |