| CTRI Number |
CTRI/2025/02/081012 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Comparison of Ropivacaine with Tramadol vs. Ropivacaine with Nalbuphine for Pain Management in Lower Abdominal Surgeries |
|
Scientific Title of Study
|
An Observational study of comparison of Isobaric Ropivacaine 0.75% with Tramadol and Isobaric Ropivacaine 0.75% with Nalbuphine intrathecally 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 |
Dr Suhani Jain |
| Designation |
Resident doctor |
| 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 |
9404565560 |
| Fax |
|
| Email |
suhanijain.dr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Chauhan |
| 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 |
9099014672 |
| Fax |
|
| Email |
dr.dinesh77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Chauhan |
| 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
GUJARAT
391760
India |
| Phone |
9099014672 |
| Fax |
|
| Email |
dr.dinesh77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Smt Bhikiben Kanjibhai Shah Medical Institute and Research
Center,wagodhia,pipariya,vadodara,india pincode-391760 |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Center |
| Address |
Wagodhia , Pipariya, Vadodara, Gujarat , India Pincode- 391760 |
| 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 Dinesh Chauhan |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
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 |
9099014672
dr.dinesh77@gmail.com |
|
|
Details of Ethics Committee
|
| 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 |
Patients receiving Isobaric Inj.Ropivacaine 0.75% 3.5 ml with 1mg Inj.Nalbuphine(0.1ml) diluted till 0.5 ml with sterile NS. |
level of sensory block will be assessed at 2 and 5 min post injection and 5-min intervals till 15 minutes.
using Bromage scale,Time of onset and Duration of motor block will be recoreded
duration of analgesia will be calculated from time of intrathecal injection to the time when visual analogue scale was more than and equal to 4 |
| Comparator Agent |
patients receiving isobaric Inj.Ropivacaine 0.75% 3.5ml with inj.tramadol(25mg)0.5 ml |
level of sensory block will be assessed at 2 and 5 min post injection and 5-min intervals till 15 minutes.
using Bromage scale,Time of onset and Duration of motor block will be recoreded
duration of analgesia will be calculated from time of intrathecal injection to the time when visual analogue scale was more than and equal to 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to sign informed consent.
ASA I & ASA Ill patients undergoing infraumbilical surgeries.
Patients in the age between 18- 65 years.
No known history of allergy, sensitivity or other form of reaction to local anesthetics of the ester and amide type and to opioids
|
|
| ExclusionCriteria |
| Details |
Patient refusal.
Allergy to any drugs.
History of seizure disorder.
Known allergy to trial drug.
Patients with neurological disorders and neuropathies or receiving medications known to influence neuromuscular junction.
ASA III, IV, Patients.
Any contraindication to Spinal Anaesthesia (local site infection, spine deformity, clotting abnormalities)
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| This observational study will help us to evaluate whether Ropivacaine with Tramadol or Ropivacaine with Nalbuphine intrathecally is better for infra-umbilical surgeries |
level of sensory block assessed at 2 and 5 min post injection and at 5 min interval till 15 minutes.
onset of sensory block and duration of sensory block.
assessment of motor blockae using bromage scale,time of onset(time from from intrathecal injection to chieve grae 1 motor block)and Duration of sensory block(time from intrathecal injection to reurn of sensation at L1)
assessment of motor blockade using time of onset and duration of motor block |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/03/2025 |
| 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="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
An Observational study of comparison of Isobaric Ropivacaine 0.75% with Tramadol and Isobaric Ropivacaine 0.75% with Nalbuphine intrathecally in infra-umbilical surgeries
AIM:The aim of this study is to compare the effect of addition of nalbuphine 1 mg to isobaric ropivacaine 0.75% and tramadol 25mg to isobaric ropivacaine 0.75% on onset and duration of sensory and motor blockade, hemodynamic stability, duration of postoperative analgesia and complications if any in patients undergoing infra-umbilical surgeries
OBJECTIVES: The objectives are: 1) To compare onset of sensory and motor blockade 2) To compare duration of sensory and motor blockade 3) To compare the changes in pulse rate, blood pressure, oxygen saturation and respiratory rate 4) To compare duration of analgesia 5) To compare side effects/complications if any 6) To compare number of rescue analgesia required in 24 hours
STUDY AREA: SBKS MEDICAL INSTITUTE AND RESEARCH CENTRE, SUMANDEEP VIDYAPEETH, PIPARIA, WAGHODIA, VADODARA, GUJARAT. DESIGN OF STUDY: Observational study
GROUP T- Patients receiving Isobaric Inj.Ropivacaine 0.75% 3.5 ml + Inj tramadol(25mg) 0.5 ml GROUP N- Patients receiving Isobaric Inj.Ropivacaine 0.75% 3.5 ml +1 mg Inj. Nalbuphine(0.1 ml)diluted till 0.5 ml with Sterile NS.
LIKELY OUTCOME /BENEFITS OF STUDY This observational study will help us to evaluate whether Ropivacaine with Tramadol or Ropivacaine with Nalbuphine intrathecally is better for infra-umbilical surgeries. We will be able to know which drug is better in view of post-operative analgesia with minimum hemodynamic stability and less side effects.
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