Comparing Epidural Buprenorphine vs Epidural Tramadol for management of pain after operation in patients undergoing replacement surgeries

A Prospective study to compare epidural buprenorphine versus epidural tramadol for post operative analgesia in lower limb orthopedic replacement surgeries. - nil

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/084623

Enrollment

Registered

2025-04-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Group B(Buprenorphine group): Group B(Buprenorphine group) will receive Inj.buprenorphine 100mcg diluted with Normal saline to make a total volume of 10ml given via epidural route afte

Eligibility

Inclusion criteria

Inclusion criteria: 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 range of 18 and 60 years. 4)Patients undergoing elective lower limb orthopedic replacement surgeries under spinal anaesthesia.

Exclusion criteria

Exclusion criteria: 1)Patients unwilling to participate in the study. 2) Patients belonging to ASA Grade III or more. ? Pregnant or lactating woman. 3)History of known allergy to study drug. 4)Patients having any vertebral anomalies. 5)Patients who needs supplementation of general anaesthesia. 6)Any contraindication to Epidural Anaesthesia (local site infection, coagulation disorder, raised intacranial pressure, hemodynamic instability, neurological disorders).

Design outcomes

Primary

Measure	Time frame
This observational study will help us to know between epidural buprenorphine and epidural tramadol which drug provides better postoperative analgesia with minimal side effects in patients undergoing lower limb replacement surgeries.Timepoint: 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 12th hour after the administration of the drug via epidural route.	—

Measure

Time frame

This observational study will help us to know between epidural buprenorphine and epidural tramadol which drug provides better postoperative analgesia with minimal side effects in patients undergoing lower limb replacement surgeries.Timepoint: 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 12th hour after the administration of the drug via epidural route.

—

Secondary

Measure	Time frame
to compare the hemodynamics of the two groups.Timepoint: vitals will be taken at baseline,15mminutes, 30 minutes, 60 minutes, 120 minutes, 240 minutes. Baseline vitals will be marked before epidural injection.	—

Countries

India

Contacts

Public ContactDr Sara Mary Thomas

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

sara.cinosh@gmail.com9646500158

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026