Intrathecal Nalbuphine Versus Intrathecal Tramadol in Subarachnoid Block for Lower Limb Orthopaedic Surgeries

Comparison of Intrathecal Nalbuphine Versus Intrathecal Tramadol as Adjuvants in Subarachnoid Block for Lower Limb Orthopaedic Surgeries

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07294352

Enrollment

Registered

2025-12-19

Start date

2026-01-01

Completion date

2026-08-01

Last updated

2026-09-11

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

Conditions

Adjuvants, Anesthesia, Subarachnoid Block

Keywords

Subarachnoid block, Adjuvants

Brief summary

This study compares the use of intrathecal nalbuphine versus intrathecal tramadol as adjuvant agents to local anaesthetics in subarachnoid block for lower-limb orthopaedic surgeries. The primary objective is to determine whether there is a meaningful difference between the two drugs in terms of quality and duration of intraoperative and postoperative analgesia. Secondary outcomes include onset and efficacy of sensory and motor block, time to first rescue analgesia, incidence of adverse effects, and perioperative hemodynamic stability. By evaluating these parameters, the study aims to identify which adjuvant provides superior analgesic benefits with fewer side effects in patients undergoing lower-limb orthopedic procedures.

Detailed description

The effectiveness of Intrathecal Nalbuphine 1mg versus Intrathecal Tramadol 20mg as adjuvant to 0.5% hyperbaric bupivacaine in Subarachnoid block for orthopaedic surgeries of the lower limbs is studied. Primary outcomes of the study are onset of sensory block, onset of motor block, intraoperative hemodynamic stability and postoperative analgesia measured on visual analog scale. Secondary outcomes were incidence of side-effects and the need for rescue analgesia.

Interventions

DRUGIntrathecal tramadol with spinal anesthsia

intrathecal tramadol 20mg with Hyperbaric 0.5% bupivacaine

DRUGIntrathecal nalbuphine and spinal anesthesia

intrathecal nalbuphine 1mg with 0.5% Hyperbaric Bupivacaine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

* ASA Physical Status 1 and 2 Undergoing surgical correction of lower limb fracture

Exclusion criteria

* hypersensitivity to opioids or local anesthetics patient refusal

Design outcomes

Primary

Measure	Time frame	Description
Duration of spinal anesthesia	up to 24 hours post operatively	Time until first rescue analgesia at VAS \<4. (Visual Analog scale measures subjective pain intensity on a continuous scale. Score 0 means no pain while 10 means most pain possible)

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026