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Comparing Two Pain Medications to Improve Pain Relief in Leg Surgery

A comparative study of intrathecal Nalbuphine and Buprenorphine as an adjuvant to 0.5% hyperbaric Bupivacaine in lower limb orthopedic surgeries - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096062
Enrollment
120
Registered
2025-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: S729- Unspecified fracture of femur Health Condition 2: S829- Unspecified fracture of lower leg Health Condition 3: S999- Unspecified injury of ankle and foot Health Condition 4: S00-T88- Injury, poisoning and certain other consequences of external causes

Interventions

Intervention1: Nalbuphine: Intrathecal Nalbuphine 0.4mg will be used as an adjuvant to hyperbaric bupivacaine Control Intervention1: Buprenorphine: Intrathecal Buprenorphine 60mcg will be used as an a

Sponsors

Dr Sanjana M B
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients willing to give informed written consent 2. American Society of Anaesthesiologists physical status grade I II aged between 18- 60 years 3. Patients weighing 50-80kgs, Patients of height 150-170cms with BMI of 22.2 to 27.7 4. Scheduled to undergo lower limb orthopaedic surgeries

Exclusion criteria

Exclusion criteria: 1. Allergy to local anaesthetics 2. Infection at the site of injection 3. Coagulopathy 4. Chronic pain syndromes 5. Prolonged opioid medication 6. Chronic liver disease, chronic renal disease, and cognitive impairment 7. Combined spinal epidural anaesthesia 8. Surgeries exceeding 6 hours 9. Surgeries that are converted to general anesthesia 10. Morbid obesity (BMI more than 40) 11. Pregnancy, parturients and nursing mothers

Design outcomes

Primary

MeasureTime frame
To assess the duration of analgesiaTimepoint: Post operative pain will be assessed every 60 mins for 4 hours from onset of analgesia

Secondary

MeasureTime frame
1.To assess the onset of sensory & motor blockade 2.To assess the duration of motor blockade 3.To compare the hemodynamics 4.To assess the side effects encountered if anyTimepoint: Hemodynamic parameters will be assessed at 0, 1, 3, 5, 10, 15, 30, 60, 90, 120, 180 mins

Countries

India

Contacts

Public ContactDr Soumya Rohit

Bangalore Medical College and Research Institute

dr.soumyarohit@gmail.com9611106641

Outcome results

None listed

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