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Compare Nalbuphine and Buprenorphine in spinal anaesthesia for post operative pain relief.

Comparison of Nalbuphine versus Buprenorphine as an intrathecal adjuvant to hyperbaric Bupivacaine for post operative analgesia in lower limb surgeries.

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/01/030672
Enrollment
46
Registered
2021-01-21
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: Intrathecal adjuvants: 1mg of Nalbuphine along with 15mg of 0.5% hyperbaric Bupivacaine as a single dose will be given intrathecally before surgery. Intervention2: Intrathecal adjuvants

Sponsors

university college of medical sciences and GTB hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients belonging to ASA grade 1 and 2 who are undergoing orthopedic lower limb surgery with height >150cm and <180cm.

Exclusion criteria

Exclusion criteria: Patients with contraindication to spinal anaesthesia of body weight >120kg with known allergy to study drug. Patient with history of chronic pain or long term opioid use. Patient refusal. Multiple fractures preventing proper assessment of anaesthesia.

Design outcomes

Primary

MeasureTime frame
Duration of post operative analgesia.Timepoint: pain will be assessed every 30 minutes for first 2 hours, at 4th, 8th, 12th and 24th hour respectively.

Secondary

MeasureTime frame
Post operative pain assessment and total analgesic requirement.Timepoint: For 24 hours.;Time of onset, intensity and duration of mootor block.Timepoint: onset is time taken to reach modified bromage grade 3. Duraton is time taken to reach modified bromage grade 0.;Time of onset, maximum level, time to achieve maximum level and duration of sensory block.Timepoint: onset is time taken for block to reach T10 segment.

Countries

India

Contacts

Public ContactDr Jobin C Mathai

University college of medical sciences and GTB hospital

sujatac462@gmail.com9625900800

Outcome results

None listed

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