| CTRI Number |
CTRI/2025/07/090810 [Registered on: 14/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative study of nalbuphine versus dexmedetomidine as adjuvant to 0.75% hyperbaric ropivacaine in patients undergoing lower limb surgeries under spinal anaesthesia |
|
Scientific Title of Study
|
COMPARATIVE STUDY OF NALBUPHINE VS DEXMEDETOMIDINE AS ADJUVANT TO 0.75% HYPERBARIC ROPIVACAINE IN PATIENTS UNDERGOING LOWER LIMB SURGERIES UNDER SPINAL ANAESTHESIA |
| Trial Acronym |
NADIR Trial |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saima Z |
| Designation |
Postgraduate Student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, K.R. Road, Fort
Bangalore
KARNATAKA
560002
India |
| Phone |
08825588415 |
| Fax |
|
| Email |
saimazaheer89@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjunatha S M |
| Designation |
Assistant Professor |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, K.R. Road, Fort
Bangalore
KARNATAKA
560002
India |
| Phone |
9958811408 |
| Fax |
|
| Email |
someshwaram18@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saima Z |
| Designation |
Postgraduate Student |
| Affiliation |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, K.R. Road, Fort
Bangalore
KARNATAKA
560002
India |
| Phone |
08825588415 |
| Fax |
|
| Email |
saimazaheer89@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore Medical College and Research Institute |
|
|
Primary Sponsor
|
| Name |
Bangalore Medical College and Research Institute |
| Address |
Department of Anaesthesiology,
Bangalore Medical College and Research Institute,
K.R. Road, Fort, Bengaluru – 560002 |
| 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 Saima Z |
Bangalore Medical College and Research Institute |
Department of Anaesthesiology, Bangalore Medical College and Research Institute, K.R. Road, Fort
Bangalore
KARNATAKA |
08825588415
saimazaheer89@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| InstitutionalEthicsCommittee, Bangalore Medical College and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. Dexmedetomidine 5 mcg |
Intrathecal injection of 5 mcg Dexmedetomidine as an adjuvant to 0.75% hyperbaric Ropivacaine.Patients will be observed postoperatively for 6 hours to assess duration of analgesia. |
| Intervention |
Inj. Nalbuphine 0.5 mg |
Intrathecal injection of 0.5 mg Nalbuphine as an adjuvant to 0.75% hyperbaric Ropivacaine.Patients will be observed postoperatively for 6 hours to assess duration of analgesia and related parameters. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.ASA physical status I and II
2. Patients aged 18 to 65 years
3. Elective lower limb surgeries under spinal anaesthesia
4. Written informed consent obtained |
|
| ExclusionCriteria |
| Details |
1.Allergy to study drugs
2. Coagulopathy or anticoagulant therapy
3. Severe hepatic or renal or cardiac diseases
4. Local infection at injection site
5. Neurological deficits or spine deformities
6. Pregnancy or lactation
7. Refusal to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of effective analgesia (time from intrathecal injection to first request for rescue analgesia) |
At time of first request for rescue analgesia, up to 6 hours post intrathecal injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory blockade |
From intrathecal injection to loss of pinprick sensation at T12 dermatome
|
| Onset and duration of motor blockade |
Time to achieve Bromage score 3 and duration until return to score 0 |
|
|
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 4 |
|
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="0"
Months="8"
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 is a prospective randomized controlled trial to compare the efficacy of intrathecal Nalbuphine and Dexmedetomidine as adjuvants to 0.75% hyperbaric Ropivacaine in patients undergoing lower limb surgeries under spinal anaesthesia. The study aims to evaluate duration of effective analgesia, onset and duration of sensory and motor block, hemodynamic parameter, incidence of adverse effects. A total of 60 adult patients will be enrolled and randomized into two groups. |