| CTRI Number |
CTRI/2024/08/072624 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
17/08/2024 |
| 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
|
Comparing Pain Relief of Nalbuphine and Butorphanol with Ropivacaine in Abdominal and Leg surgeries |
|
Scientific Title of Study
|
Comparison of the analgesic efficacy of nalbuphine versus butorphanol as an adjuvant to 0.75 percentage hyperbaric ropivacaine in lower abdominal and lower limb 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 |
Dr Mridula T V |
| Designation |
Post Graduate |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Karnataka Institute of Medical Sciences,Vidyanagar,Hubballi,Dharwad
Dharwad
KARNATAKA
580021
India |
| Phone |
9544083429 |
| Fax |
|
| Email |
mridulaatv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jyothi B |
| Designation |
Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Karnataka Institute of Medical Sciences,Vidyanagar,Hubballi,Dharwad
Dharwad
KARNATAKA
580021
India |
| Phone |
9886187056 |
| Fax |
|
| Email |
drjyothib1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Jyothi B |
| Designation |
Professor |
| Affiliation |
Karnataka Institute of Medical Sciences |
| Address |
Department of Anaesthesiology,Karnataka Institute of Medical Sciences,Vidyanagar,Hubballi,Dharwad
Dharwad
KARNATAKA
580021
India |
| Phone |
9886187056 |
| Fax |
|
| Email |
drjyothib1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Karnataka Institute of Medical Sciences,Vidyanagar,Hubballi,Dharwad,Karnataka 580021,India
|
|
|
Primary Sponsor
|
| Name |
DR MRIDULA T V |
| Address |
Department of Anaesthesiology,Karnataka Institute of Medical Sciences,Vidyanagar,Hubballi,Dharwad-580021 |
| 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 |
| DR Mridula T V |
Karnataka Institute of Medical Sciences |
Room number 206,Department of Anaesthesiology,Vidyanagar,Hubballi,Dharwad-580021
Dharwad
KARNATAKA |
9544083429
mridulaatv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Karntaka Institute of Medical Sciences,Hubballi |
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 |
GROUP B (0.75% hyperbaric ropivacaine and butorohanol) |
0.75% hyperbaric ropivacaine 2.2 ml (16.5 mg)+0.5 ml (25 µg) of butorohanol(B) + 0.3 ml normal saline intrathecally once.
Post operative analgesic efficacy assessed over 20 hours |
| Intervention |
GROUP N(0.75% hyperbaric ropivacaine and nalbuphine) |
0.75% hyperbaric ropivacaine 2.2 ml (16.5 mg)+0.8 ml (0.8mg) of nalbuphine (N) intrathecally once.
Post operative analgesic efficacy assessed over 20 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status 1 and 2
2. BMI range of 18.5 to 24.9 |
|
| ExclusionCriteria |
| Details |
1.Infection at the site
2.Spinal deformity such as kyphoscoliosis
3.Bleeding disorders
4.Allergic reaction to study drugs
5.Patients on tranquilizers,hypnotics,sedatives and other psychotropic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative analgesic duration |
Pain assessment 2 hourlies until 12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The onset of sensory and motor blockade
|
Assessed immediately after spinal injection then, every 3 minutes until 15 minutes, then every 10 minutes upto 1 hour, then every 30 minutes upto 2 hours and then hourly till the end of the surgery |
| Duration of sensory blockade |
Assessed 2 hourlies until 12 hours of post surgery |
| Duration of motor blockade |
Assessed 2 hourlies until 12 hours of post surgery |
|
|
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 2 |
|
Date of First Enrollment (India)
|
28/08/2024 |
| 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="0"
Months="10"
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
|
Effective post operative analgesia is an important factor for the early ambulation.This is a type of prospective ,randomised double blinded study in which comparison of analgesic efficacy of nalbuphine and butorphanol as an adjuvant to 0.75% hyperbaric ropivacaine in patient undergoing lower abdominal and lower limb surgeries.Totally there are 2 groups each containing 30 persons and total sample size is 60. |