| CTRI Number |
CTRI/2025/04/084723 [Registered on: 15/04/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Inj Nalbuphine vs Inj Tramadol given in addition to 0.2 percent Ropivacaine via epidural route for pain relief after operation in patients undergoing orthopedic surgeries involving lower limb. |
|
Scientific Title of Study
|
A prospective study to compare epidural nalbuphine versus epidural tramadol as an adjuvant to 0.2 percentage ropivacaine for post operative analgesia in lower limb orthopaedic surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akashi Shah |
| Designation |
Resident doctor |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and research centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre Pipira Waghodia Vadodra
Vadodara
GUJARAT
391730
India |
| Phone |
08980009010 |
| Fax |
|
| Email |
akashishah7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sara Mary Thomas |
| Designation |
Professor and HOD |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
Vadodara
GUJARAT
391760
India |
| Phone |
09646500158 |
| Fax |
|
| Email |
sara.cinosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sara Mary Thomas |
| Designation |
professor and HOD |
| Affiliation |
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Anaesthesia Department, General Ot Complex, 2nd Floor, Dhiraj
Hospital, Smt.Bhikiben Kanjibhai Shah Medical Institute and
Research Centre, Waghodiya, Piparia ,Vadodara,GUJARAT,391760
Vadodara
GUJARAT
391730
India |
| Phone |
08980009010 |
| Fax |
|
| Email |
akashishah7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Anaesthesia Department General Ot Complex 1st Floor Dhiraj Hospital
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Piparia Wagodiya Vadodara GUJARAT India |
|
|
Primary Sponsor
|
| Name |
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
| Address |
Piparia Wagodiya Vadodara GUJARAT 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 |
| Akashi Shah |
Dhiraj Hospital Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre |
Dhiraj Hospital
Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Piparia Wagodiya Vadodara GUJARAT India - 391760
Vadodara
GUJARAT |
8980009010
akashishah7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sumandeep vidyapeeth institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M16||Osteoarthritis of hip, (2) ICD-10 Condition: M17||Osteoarthritis of knee, (3) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (4) ICD-10 Condition: S70-S79||Injuries to the hip and thigh, (5) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
To Inj Ropivacaine (0.2 percent) 9 ml, Inj Nalbuphine 10 mg ( 1ml) is added (Total 10ml) given via epidural route . |
The VAS is assessed every half hourly after surgery. When VAS is more than equal to 4 then epidural dose is administered. The VAS is noted at the time of administration of drug and every hour after the administration of the drug till the VAS becomes 4 again or 10 hours, whichever is earlier. |
| Comparator Agent |
To Inj Ropivacaine (0.2 percent) 9 ml, Inj Tramadol 50 mg ( 1ml) is added (Total 10ml) given via epidural route. |
The VAS is assessed every half hourly after surgery. When VAS is more than equal to 4 then epidural dose is administered. The VAS is noted at the time of administration of drug and every hour after the administration of the drug till the VAS becomes 4 again or 10 hours, whichever is earlier. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient willing to sign the written informed consent.
2) Patients belonging to American Society of Anaesthesiologists (ASA) Grade I or II.
3) Male or female patients between age 18-60 years.
4) Patients undergoing elective lower limb orthopedic surgeries under spinal anesthesia.
|
|
| ExclusionCriteria |
| Details |
1) Patients unwilling to participate in the study.
2) Patients belonging to ASA Grade III or more.
3) Pregnant or lactating woman.
4) History of known allergy to study drug.
5) Patients having any vertebral anomalies.
6) Patients who needs supplementation of general anaesthesia.
7) Any contraindication to Epidural Anaesthesia (local site infection, coagulation disorder, raised intacranial pressure, hemodynamic instability, neurological disorders,).
8) Children less than 18 years
9) Adults more than 60 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
This observational study will help us to know between epidural nalbuphine and epidural tramadol which as adjuvant to 0.2% ropivacaine provides better postoperative analgesia
with minimal side effects in patients undergoing lower limb orthopaedic surgeries. |
postoperatively,the study drug will be administered via epidural route when VAS more than equal to 4.
* The VAS before administration of drug is considered as "Base Line".
* VAS is noted immediately after administration of drug
* VAS is noted at 1st, 2nd, 3rd, 4th and so on till 10th hour after the administration of the drug via epidural route. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the hemodynamics of the two groups |
Blood Pressure, Pulse rate & Oxygen Saturation will be measured
1) at the time of administration of the drug as Baseline.
2) at 15 mins
3) at 30 mins
4) at 1 hour
5) at 2 hour
6) at 3 hour
7) at 4 hour
8) at 5 hour
9) at 6 hour
10) at 7 hour
11) at 8 hour
12) at 9 hour
13) at 10 hour
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
22/04/2025 |
| 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 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 observational study aims to compare the postoperative analgesic efficacy of epidural buprenorphine and epidural tramadol in lower limb orthopedic replacement surgeries. Conducted at Dhiraj Hospital, Vadodara, the study involves 60 patients aged 18–60 years, classified as ASA Grade I or II, undergoing elective lower limb orthopedic replacement surgeries under spinal anesthesia. Participants are randomly divided into two groups: Group N (receiving epidurally 0.5% ropivacaine 9ml with nalbuphine 10mg) and Group T (receiving epidurally 0.5% ropivacine 9ml with 50 mg tramadol), both diluted with normal saline to a total volume of 10 ml. The study evaluates the onset, duration, and quality of analgesia, as well as hemodynamic changes between the groups. Exclusion criteria include ASA Grade III or higher, pregnancy, allergies to study drugs, vertebral anomalies, and contraindications to epidural anesthesia. Informed consent is obtained from all participants. The procedure is administered by an anesthesiologist unrelated to the study, ensuring unbiased results. The findings are expected to determine which drug offers superior postoperative analgesia with fewer side effects, providing valuable insights for optimizing pain management in patients undergoing such surgeries. This research seeks to enhance clinical outcomes and patient comfort in postoperative care. |