| CTRI Number |
CTRI/2026/02/103184 [Registered on: 06/02/2026] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two different doses of Nalbuphine as an adjuvant to Caesarean Section. |
|
Scientific Title of Study
|
Comparison of two different doses of Nalbuphine as an adjuvant to 0.75% Hyperbaric Ropivacaine for postoperative analgesia in parturients undergoing lower segment caesarean section under subarachnoid block. A randomized double-blinded controlled 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 |
Dr Kamini Kumari |
| Designation |
Resident Doctor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia
R.N.T Medical College ,Udaipur
Near Chetak Circle ,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9606321880 |
| Fax |
|
| Email |
kumari.kamini1302@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajeev Navariya |
| Designation |
Associate Professor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia
R.N.T.Medical College ,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9099908770 |
| Fax |
|
| Email |
drrajeevnavaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajeev Navariya |
| Designation |
Associate Professor |
| Affiliation |
R.N.T Medical College |
| Address |
Department of Anaesthesia
R.N.T.Medical College ,Udaipur
Udaipur
RAJASTHAN
313001
India |
| Phone |
9099908770 |
| Fax |
|
| Email |
drrajeevnavaria@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.N.T Medical College , Udaipur 313001 ,Rajasthan ,India |
|
|
Primary Sponsor
|
| Name |
RNT Medical College |
| Address |
Near Chetak Circle ,Udaipur 313001, India |
| Type of Sponsor |
Government 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 Kamini Kumari |
Maharana Bhupal Hospital |
Department of Anaesthesia,R.N.T Medical College , Udaipur
Udaipur
RAJASTHAN |
9606321880
kumari.kamini1302@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ith Reply No of Ethics Committees= 1 Name of Committee Ethics Committee registered with DHR /CDSCO or not Ethics Committee Registration No. Approval Status Date of Approval Approval Document Is IEC? IEC RNT MEDICAL COLLEGE RESEARCHER AND CONTROLLER UDAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal 15 mg of 0.75 percent Hyperbaric Ropivacaine in Lower Segment Caesarean Section under Subarachnoid Block . |
Intrathecal 15 mg of 0.75 percent Hyperbaric Ropivacaine in Lower Segment Caesarean Section under Subarachnoid Block . |
| Intervention |
Intrathecal Nalbuphine 0.4 mg with 15 mg of 0.75 percent hyperbaric Ropivacaine in Lower Segment Caesarean Section under Subarachnoid Block. |
Intrathecal Nalbuphine 0.4 mg with 15 mg of 0.75 percent hyperbaric Ropivacaine in Lower Segment Caesarean in Subarachnoid Block. |
| Intervention |
Intrathecal Nalbuphine 0.8 mg with 15 mg of 0.75 percent
Hyperbaric Ropivacaine in Lower Segment Caesarean Section under Subarachnoid Block. |
Intrathecal Nalbuphine 0.8 mg with 15 mg of 0.75 percent Hyperbaric Ropivacaine in Lower Segment Caesarean Section under Subarachnoid Block. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
Term parturients aged 18–35 years with ASA physical status II, scheduled for elective uncomplicated lower segment caesarean section under subarachnoid block, and willing to provide written informed consent will be included in the study. |
|
| ExclusionCriteria |
| Details |
Parturients refusing to participate, those with ASA physical status III or above, body mass index more than 35 kg/m², known hypersensitivity to local anaesthetics or Nalbuphine, presence of cardiac, renal or hepatic disease, pre-existing neurological disorders or peripheral neuropathy, those on anticoagulant therapy or having coagulation abnormalities, infection at the site of lumbar puncture, or any contraindication to subarachnoid block will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome of the study is the duration of postoperative analgesia |
AT BASELINE 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24
HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary outcomes include assessment of the onset of sensory block, onset of motor block, highest level of sensory block achieved, two-segment regression time of sensory block, duration of sensory block, & duration of motor block. Postoperative pain will be evaluated using the Visual Analogue Scale (VAS). Neonatal outcome will be assessed using APGAR scores at 1 & 5 minutes after delivery. Haemodynamic parameters such as heart rate, systolic blood pressure, diastolic blood pressure & mean arterial pressure will be monitored. The incidence of side effects including nausea, vomiting, hypotension, bradycardia, pruritus, sedation & respiratory depression will also be recorded. |
AT BASELINE 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24
HOURS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/02/2026 |
| 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
|
This randomized double-blinded controlled study aims to compare the analgesic efficacy of two different doses of intrathecal Nalbuphine (0.4 mg and 0.8 mg) used as an adjuvant to 0.75% hyperbaric Ropivacaine in parturients undergoing elective lower segment caesarean section under subarachnoid block. A total of 105 parturients will be randomly allocated into three groups to receive either hyperbaric Ropivacaine alone or in combination with Nalbuphine. The primary outcome is the duration of postoperative analgesia, while secondary outcomes include sensory and motor block characteristics, postoperative pain scores, haemodynamic stability, neonatal outcome assessed by APGAR scores, and the incidence of adverse effects. The study intends to identify the optimal dose of intrathecal Nalbuphine that provides effective and prolonged analgesia with minimal side effects. |