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Evaluation of Intrathecal Nalbuphine versus Buprenorphine as Adjuvant to 0.5 percent Hyperbaric Levobupivacaine in Lower Limb Orthopaedic Surgeries: A Prospective Randomized Double-Blinded Study

Evaluation of Intrathecal Nalbuphine versus Buprenorphine as adjuvant to 0.5 percent Hyperbaric Levobupivacaine in Lower limb Orthopaedic Surgeries A Prospective Randomized Double Blinded Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/07/113893
Enrollment
84
Registered
2026-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

None listed

Interventions

Intervention1: Nil: Nil Intervention2: Intrathecal nalbuphine added to 0.5 percent hyperbaric levobupivacaine.: Intrathecal nalbhuphine added to 0.5 percent hyperbaric Levobupivacaine. Approximate

Sponsors

Akshath H S
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patient willing to be part of the study. 2. Age group 18-60 of either sex. 3. ASA Class 1 and 2 4. BMI less than 35 5. Lower limb surgeries

Exclusion criteria

Exclusion criteria: 1.Patient refusal. 2.Patients with significant coagulopathies and other contraindications for subarachnoid block. 3.Patients allergic to drugs. 4.Duration of surgery more than 120 minutes.

Design outcomes

Primary

MeasureTime frame
To compare the onset and duration of sensory and motor blockade of 3ml of 0.5 percent Levobupivacaine with buprenorphine 90 mcg or nalbuphine 1.5 mg in subarachnoid block for lower limb surgeries.Timepoint: From intrathecal injection until first request for rescue analgesia or VAS is more than or equal to 4 VAS assessed at 30 minutes, 1, 2, 4, 6, 8, 12, and 24 hours postoperatively—

Secondary

MeasureTime frame
1. To compare the duration postoperative analgesia. 2. To compare the hemodynamic changes. 3. To compare the adverse effects. Timepoint: Every 30 seconds after intrathecal injection until T10 level is achieved Every 2 minutes for the first 10 minutes Every 30 seconds until Modified Bromage Score 3 30 minutes, 1, 2, 4, 6, 8, 12, & 24 hours postoperatively—

Countries

India

Contacts

Public ContactDr Mohammad Anwar Hussain

SDM College of Medical Sciences and Hospital

dranwarh17@gmail.com9902839315

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026