| CTRI Number |
CTRI/2025/09/094695 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
11/09/2025 |
| 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
|
A clinical study comparing the effects of two drugs, Nalbuphine and Pentazocine, when used with spinal anaesthesia for operations below the waist |
|
Scientific Title of Study
|
A Comparative study: Intrathecal Nalbuphine versus Intrathecal Pentazocine as adjuvant to 0.5% Hyperbaric Bupivacaine for infraumbilical surgeries under 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 |
Swathi Kilari |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8885664433 |
| Fax |
|
| Email |
kilariswathi423@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shital K Madavi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9921838568 |
| Fax |
|
| Email |
msheetal025@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shital K Madavi |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College, Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Anaesthesiology, Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9921838568 |
| Fax |
|
| Email |
msheetal025@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College, Sawangi Meghe, Wardha, 442001 |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Medical College |
| Address |
Sawangi Meghe, Wardha, Maharashtra, India, 442001 |
| 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 Swathi Kilari |
Jawaharlal Nehru Medical College |
Department of Anaesthesiology Jawaharlal Nehru Medical College Sawangi Meghe Wardha
Wardha
MAHARASHTRA |
8885664433
kilariswathi423@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research (Deemed to be 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 |
| Intervention |
Nalbuphine |
Nalbuphine acts as a kappa receptor agonist and µ-opioid receptor antagonist, offering significant analgesia with minimal side effects such as respiratory depression, pruritus, and nausea. |
| Comparator Agent |
Pentazocine |
Pentazocine primarily stimulates kappa receptors and exerts partial agonist or antagonist effects on µ-receptors, modulating pain at the spinal cord level. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving informed consent
ASA grade one or two
Patients scheduled for elective lower abdominal, perineal, or lower limb surgeries |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study
ASA grade three and above
Patients with uncontrolled or labile hypertension, Diabetes Mellitus, psychiatric disorders, history of chronic low back pain, evidence of hepatic or renal dysfunction, known hypersensitivity to local anaesthetics or opioids |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesia provided by intrathecal nalbuphine and pentazocine when used as adjuvants to 0.5% hyperbaric bupivacaine |
time(in minutes) to first rescue analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the onset time and duration of sensory and motor block between the two adjuvant groups.
|
Onset of sensory block: Time interval (in minutes) from the completion of intrathecal drug injection to the complete loss of pinprick sensation at the surgical dermatome level
Onset of motor block: Time (in minutes) from intrathecal injection to the patient’s inability to lift the extended lower limb against gravity
Duration: Time(in minutes) from intrathecal injection to the first patient-reported pain score of VAS more than 3 |
To assess and compare intraoperative and postoperative hemodynamic parameters (heart rate, blood pressure) in both groups.
|
Intraoperative parameters: Every 10 minutes
Postoperative parameters: 0, 6, 12 and 24 hours |
| To evaluate the incidence of adverse effects such as nausea, vomiting, hypotension, bradycardia, pruritus, and respiratory depression associated with each adjuvant. |
Noted till 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
22/09/2025 |
| 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="2"
Months="0"
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 is a prospective randomized double blinded study for a 2 year period to compare the effect of intrathecal nalbuphine and intrathecal pentazocine as adjuvants to 0.5 percent hyperbaric bupivacaine in patients undergoing infraumbilical surgeries under subarachnoid block. This study includes the comparison between the onset of time and duration of sensory and motor block between the two groups, assessment of intraoperative and postoperative hemodynamic parameters between the groups and evaluate the incidence of adverse effects. |