| CTRI Number |
CTRI/2025/05/087623 [Registered on: 26/05/2025] Trial Registered Prospectively |
| Last Modified On: |
25/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of bupivacaine and bupivacaine with nalbuphine in ultrasound-guided popliteal nerve block - A double blinded randomized control study |
|
Scientific Title of Study
|
A comparative study on Bupivacaine with Normal Saline versus Bupivacaine with Nalbuphine in ultrasound guided popliteal blocks - A double blinded randomized control 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 Jeevakaarunya K M |
| Designation |
DNB Resident |
| Affiliation |
Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation) |
| Address |
Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation)
Operation theatre,1st floor,Department of Anaesthesia ,Shanthi colony ,Anna Nagar,Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
7867031139 |
| Fax |
|
| Email |
sibirangasamy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jeyakumar V |
| Designation |
Consultant (Department of Anaesthesia) |
| Affiliation |
Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation) |
| Address |
Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation)
Operation theatre,1st floor,Department of Anaesthesia ,Shanthi colony ,Anna Nagar,Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
9677069286 |
| Fax |
|
| Email |
Jaya_kumar380@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jeevakaarunya K M |
| Designation |
DNB Resident |
| Affiliation |
Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation) |
| Address |
Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation)
Operation theatre,1st floor,Department of Anaesthesia ,Shanthi colony ,Anna Nagar,Chennai
Chennai
TAMIL NADU
600040
India |
| Phone |
7867031139 |
| Fax |
|
| Email |
sibirangasamy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rangarajan Memorial Hospital( Sundaram Medical Foundation)9C,4th Avenue,AH Block,Shanthi colony,Anna nagar , Chennai , Tamil Nadu 600040 |
|
|
Primary Sponsor
|
| Name |
Jeevakaarunya k m |
| Address |
6/18, AJ Block ,5th street,Shanthi colony,Anna Nagar 600040 |
| Type of Sponsor |
Other [Post graduate thesis study] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Rangarajan Memorial Hospital Sundaram Medical Foundation |
1st Floor,Operation theatre,Shanthi colony,Anna Nagar,Chennai,Tamil Nadu 600040 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jeevakaarunya K M |
Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation) |
Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation)
1st Floor,Operation theatre,Shanthi colony,Anna Nagar,Chennai,Tamil Nadu 600040
Chennai
TAMIL NADU |
7867031139
sibirangasamy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Rangarajan Memorial Hospital (Sundaram Medical Foundation) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: G578||Other specified mononeuropathies of lower limb, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine with nalbuphine |
Patient enrolled in Group B will receive 20ml of .5% bupivacaine with 1 ml (10 mg) of nalbuphine
Route of administration- perineural
Duration- 24 hours |
| Comparator Agent |
Bupivacaine with normal saline |
Patient enrolled in group A will receive 20ml of 0.5% bupivacaine and normal saline
Route of administration- perineural Duration
Duration-24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I, II and III of either sex
2. Aged between 18-75 years
3. Admitted for below knee surgeries |
|
| ExclusionCriteria |
| Details |
1. Patient refusal and cognitive disorders
2. Patients with known hypersensitivity or contraindications to the study drugs
3. Infection at the site of block
4. Patients with advanced renal disease , hepatic or cardiac diseases
5. Patients with severe coagulopathy
6. Pregnant patients
7. Patients with Neuropathic disorder of the affected limb |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory block |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of motor block |
1 year |
| To access the time of first rescue analgesic requirement |
1 year |
| Patient satisfaction |
1 year |
| Complications of popliteal block |
1 year |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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 3 |
|
Date of First Enrollment (India)
|
05/06/2025 |
| 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="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 double-blinded randomized controlled study will be conducted to compare the efficacy of bupivacaine with nalbuphine versus bupivacaine with normal saline in ultrasound-guided popliteal nerve blocks for below-knee surgeries. A total of 58 patients aged 18 to 75 years with ASA physical status 1 to 3 will be randomly assigned to two groups. Group A will receive 20 ml of 0.5 percent bupivacaine with 1 ml normal saline, while Group B will receive 20 ml of 0.5 percent Bupivacaine with 10 mg nalbuphine. The primary objective will be to compare the onset and duration of sensory block, while secondary objectives will include motor block characteristics, time to first rescue analgesia, patient satisfaction, and block-related complications. Sensory and motor block onset and duration will be assessed using standardized methods, and pain will be monitored using the Visual Analogue Scale. This study aims to determine whether the addition of nalbuphine provides superior postoperative analgesia without additional side effects, thereby potentially improving pain management protocols for lower limb surgeries .
|