| CTRI Number |
CTRI/2025/07/091103 [Registered on: 17/07/2025] Trial Registered Prospectively |
| Last Modified On: |
16/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of two drugs Clonidine and Nalbuphine added to Ropivacaine in spinal anesthesia for better pain relief during surgeries |
|
Scientific Title of Study
|
Comparative evaluation of intrathecal clonidine and nalbuphine as an adjuvant to hyperbaric ropivacaine in subarachnoid block |
| 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 Anubhuti Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and
Research Sharda University Greater Noida Gautam Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9667661309 |
| Fax |
|
| Email |
dr.anubhuti97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish Kumar Agarwal |
| Designation |
Professor |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and
Research Sharda University Greater Noida Gautam Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9838706199 |
| Fax |
|
| Email |
manish.agarwal@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anubhuti Singh |
| Designation |
Post Graduate Resident |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and
Research Sharda University Greater Noida Gautam Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9667661309 |
| Fax |
|
| Email |
dr.anubhuti97@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Medical Sciences and Research Sharda University Gautam Buddha Nagar
Uttar Pradesh 201306 India |
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research and Sharda Hospital Greater Noida |
| Address |
School of Medical Sciences and Research Sharda University Gautam
Buddha Nagar Uttar pradesh 201306 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 Anubhuti Singh |
School of Medical Sciences and Research |
Block 2F Department of
Anaesthesiology Sharda
University, Knowledge Park
III, Greater Noida, Gautam
Buddha Nagar, Uttar
Pradesh – 201306 India
Gautam Buddha Nagar
UTTAR PRADESH
Gautam Buddha Nagar
UTTAR PRADESH |
9667661309
dr.anubhuti97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of Medical Sciences and Research Sharda University Greater Noida |
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 |
| Intervention |
Intrathecal Clonidine and Nalbuphine with Hyperbaric Ropivacaine
|
Group RC (Clonidine group): Injection hyperbaric ropivacaine 0.75%, 3.7 ml + clonidine 30 µg (0.2 ml)
Group RN (Nalbuphine group): Injection hyperbaric ropivacaine 0.75%, 3.7 ml + nalbuphine 2 mg (0.2 ml)
Group RS (Control group): Injection hyperbaric ropivacaine 0.75%, 3.7 ml + normal saline 0.2 ml
Total duration of intervention is 18 months |
| Comparator Agent |
Intrathecal Clonidine and Nalbuphine with Hyperbaric Ropivacaine |
Group RC (Clonidine group): Injection hyperbaric ropivacaine 0.75%, 3.7 ml + clonidine 30 µg (0.2 ml) Group RN (Nalbuphine group): Injection hyperbaric ropivacaine 0.75%, 3.7 ml + nalbuphine 2 mg (0.2 ml) Group RS (Control group): Injection hyperbaric ropivacaine 0.75%, 3.7 ml + normal saline 0.2 ml
Total duration of intervention is 18 months |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled for surgery under subarachnoid block
ASA physical status I and II
Patients who give informed consent
|
|
| ExclusionCriteria |
| Details |
Morbid obesity
Patient with history of adverse response to study drugs
Patient with pre-existing neurological or spinal disease, cardiovascular disease, renal, hepatic or any other systemic disease
Contraindications for spinal anaesthesia like: Raised ICP, local site infections & spinal deformities like kyphosis and scoliosis
Pregnant females
Coagulopathy or bleeding diathesis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time of onset of sensory and motor blockade (assessed using pinprick method and Modified Bromage scale respectively) |
Time of onset of sensory and motor blockade upto 24 hours postoperatively (assessed using pinprick method and Modified Bromage scale respectively) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration of sensory and motor blockade assessed by pin prick, Visual Analog Score (VAS) and modified Bromage scale respectively.
Changes in vitals parameters-heart rate (HR), noninvasive blood pressure (NIBP), and oxygen saturation (SPO2) intra operatively.
Requirement of first rescue analgesic in postoperative period in the first 24 hours. |
Assessed every 1 min until onset, then every 10 min post 2 hours until full recovery
Baseline, then every 5 minutes intraoperatively and every 15 minutes post-op for 3 hours
Monitored continuously up to 24 hours post-op |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
01/08/2025 |
| 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 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
|
This prospective, randomized, double-blind controlled trial aims to compare the effects of intrathecal clonidine and nalbuphine as adjuvants to 0.75% hyperbaric ropivacaine in patients undergoing infraumbilical surgeries under spinal anaesthesia.
A total of 75 adult patients (ASA I–II) aged 18–60 years will be randomly assigned into three groups: Group RC: Ropivacaine + Clonidine (30 mcg) Group RN: Ropivacaine + Nalbuphine (2 mg) Group RS: Ropivacaine + Normal Saline (control)
Primary outcome includes onset time of sensory and motor blockade. Secondary outcomes include duration of block, hemodynamic parameters, time to first rescue analgesic, and incidence of adverse effects. Patients will be monitored intraoperatively and for 24 hours postoperatively. The study will be conducted at Sharda Hospital, Greater Noida over 18 months. |