| CTRI Number |
CTRI/2025/08/092983 [Registered on: 13/08/2025] Trial Registered Prospectively |
| Last Modified On: |
12/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing efficacy and safety of two drugs, tramadol and buprenorphine, given through a catheter in epidural space in lower spine for post operative pain relief. |
|
Scientific Title of Study
|
Efficacy and safety of tramadol versus buprenorphine administrated epidurally for postoperative pain relief - a prospective comparative 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 |
Kousika Narasimhan |
| Designation |
First year PG resident |
| Affiliation |
Apollo KH hospital |
| Address |
Apollo KH hospital
NH 48, Chennai-Banglore highway, Melvisharam Ranipet, kanchipuram-Vellore Road, Melvisharam, Tamilnadu 632509
Vellore
TAMIL NADU
632509
India |
| Phone |
9952456765 |
| Fax |
|
| Email |
narasimhankousi17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr B Jalakandan |
| Designation |
Senior consultant and HOD of Anaesthesiology |
| Affiliation |
Department of Anesthesia, Apollo KH Hospital |
| Address |
Apollo KH hospital
NH 48, Chennai-Banglore highway, Melvisharam Ranipet, kanchipuram-Vellore Road, Melvisharam, Tamilnadu 632509
Vellore
TAMIL NADU
632509
India |
| Phone |
9994976064 |
| Fax |
|
| Email |
dr_jalakandan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr B Jalakandan |
| Designation |
Senior consultant and HOD of Anaesthesiology |
| Affiliation |
Department of Anesthesia, Apollo KH Hospital |
| Address |
Apollo KH hospital
NH 48, Chennai-Banglore highway, Melvisharam Ranipet, kanchipuram-Vellore Road, Melvisharam, Tamilnadu 632509
Vellore
TAMIL NADU
632509
India |
| Phone |
9994976064 |
| Fax |
|
| Email |
dr_jalakandan@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Apollo KH hospital NH 48, Chennai-Banglore highway, Melvisharam Ranipet, kanchipuram-Vellore Road, Melvisharam, Tamilnadu 632509 India |
|
|
Primary Sponsor
|
| Name |
Apollo KH hospital |
| Address |
Apollo KH hospital
NH 48, Chennai-Banglore highway, Melvisharam Ranipet, kanchipuram-Vellore Road, Melvisharam, Tamilnadu 632509 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 B Jalakandan |
Operation Theatre complex, Department of anesthesiology, Apollo KH Hospital, Melvisharam |
Apollo KH hospital
NH 48, Chennai-Banglore highway, Melvisharam Ranipet,
kanchipuram-Vellore Road, Melvisharam, Tamilnadu 632509
India
Vellore
TAMIL NADU |
9994976064
dr_jalakandan@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KHIHS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M20-M25||Other joint disorders, (2) ICD-10 Condition: M175||Other unilateral secondary osteoarthritis of knee, (3) ICD-10 Condition: N83||Noninflammatory disorders of ovary, fallopian tube and broad ligament, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Epidural Buprenorphine |
2 mcg per kilograms of body weight in 10 ml normal saline.
Used as analgesic. |
| Intervention |
Epidural Tramadol |
1 mg per kilograms of body weight in 10 ml normal saline.
Used as an analgesic. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to give written informed consent
American society of Anaesthesiologist class 1 and class 2
Patients undergoing elective and emergency surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal for combined spinal epidural anaesthesia
Pregnant and lactating women
Patient with hepatic and renal dysfunction
Patients allergic to tramadol or buprenorphine
Patients with COPD
Local infection at epidural site
Vertebral anomalies
Coagulopathies
Neurological diseases
Psychiatric illness
BMI more than 35 kg/m²
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative pain relief in visual analouge scale |
At baseline, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes, 360 minutes. 12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset of pain relief, time interval from administration of drug to beginning of noticeable pain relief in minutes. |
Calculated from baseline in minutes. |
Duration of pain relief.
From administration of first dose of drug till requirement of second dose of drug. |
At baseline, 30 minutes, 60 minutes, 90 minutes, 120 minutes, 180 minutes, 240 minutes, 300 minutes, 360 minutes. 12 hours & 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
01/09/2025 |
| 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="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
|
Efficacy and safety of tramadol versus buprenorphine administered epidurally for postoperative pain relief- a prospective randomized comparative study METHODOLOGY: During pre-anesthetic assessment, detailed history will be collected and the clinical
examination will be done. Relevant investigations will be obtained for each patient. The patients will
be explained about the epidural technique with catheter in situ. Patients will be explained about usage
of linear visual analogue scale for assessment of the intensity of pain. A written informed consent will
be obtained from each patient. All the patients will be kept in nil by mouth as per ASA guidelines,
prior to the surgery. All patients will be randomized into two groups, (Group T Tramadol group (n=25)
and Group B Buprenorphine group(n=25)) by lots.
All the patients in both the groups will be premedicated with Tab. Alprazolam 0.25mg per oral,
night before the scheduled day of surgery. An appropriately sized cannula will be used to secure
intravenous access. On the day of surgery, in operating room, pulse oximeter, electrocardiogram, and
non-invasive blood pressure will be connected to the patient and the baseline values will be recorded.
All the emergency drugs and airway equipment’s will be kept ready. After positioning the patient in
sitting position, under strict aseptic precautions, 18 G Tuohy epidural needle will be introduced at L1-
L2 or L2- L3 interspace and space will be confirmed using loss of resistance technique. Epidural
catheter will be inserted and fixed at the skin level as such 5cm of the catheter stays in the epidural
space. A test dose of 3ml of 2% lignocaine with adrenaline will be given to ensure that epidural catheter
is not intravascular or intrathecal. Following epidural catheter placement, all patients will be given spinal anesthesia for the
surgical procedure one interspace below epidural puncture site using 23G or 25G Quincke spinal
needle and appropriate dose of 0.5% bupivacaine heavy will be given. Sensory and motor block levels
will be assessed
Sensory block will be assessed using pinprick test to determine the level of dermatome
blocked.
Motor block will be assessed by the Bromage scale. Intraoperative epidural top up will be activated with local anesthetic once spinal effect
regresses two levels below the initial level. At the end of surgery, patients will be shifted to recovery room. Upon arrival to recovery room,
pulse rate, respiratory rate, peripheral oxygen saturation, blood pressure, pain score will be assessed
and recorded. Epidural dose of opioid will be given according to group allotted, when the patient complaints
of pain (VAS score >3)
Group T (tramadol group) will receive single dose 1mg per kg of tramadol in 10ml of normal
saline and group B (buprenorphine group) will receive single dose of 2 mcg per kg of buprenorphine
in 10ml of normal saline, via epidural catheter.
Following the first epidural opioid dose, patients will be assessed for pain intensity (VAS score) onset,
duration of analgesia, hemodynamic parameters ( heart rate, systolic blood pressure, diastolic blood pressure, percentage saturation of oxygen, respiratory rate) , adverse effects such as nausea, vomiting, pruritus, urinary retention at intervals of 0 mins, 30 mins,
1st hour, 1hour 30mins, 2nd hour, 3rd hour, 4th hour, 5th hour, 6th hour, 12th hour and 24th hour.
Duration of analgesia is assessed from the administration of first dose of drug till requirement of second dose of drug. Then study is abandoned |