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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.

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 - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/084723
Enrollment
80
Registered
2025-04-15
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: M16- Osteoarthritis of hip Health Condition 2: M17- Osteoarthritis of knee Health Condition 3: S80-S89- Injuries to the knee and lower leg Health Condition 4: S70-S79- Injuries to the hip and thigh Health Condition 5: S90-S99- Injuries to the ankle and foot

Interventions

Intervention1: 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 m

Sponsors

Smt Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Lead Sponsor

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 18-60 years. 4) Patients undergoing elective lower limb orthopedic surgeries under spinal anesthesia.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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.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 10th hour after the administration of the drug via epidural route.

Secondary

MeasureTime frame
to compare the hemodynamics of the two groupsTimepoint: 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

Countries

India

Contacts

Public ContactDr Sara Mary Thomas

Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre

sara.cinosh@gmail.com09646500158

Outcome results

None listed

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