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

CMH Lahore Medical College and Institute of Dentistry

Status: Not yet enrolling

Conditions: Adjuvants, Anesthesia; Subarachnoid Block

Treatments: Drug: Intrathecal nalbuphine and spinal anesthesia; Drug: Intrathecal tramadol with spinal anesthsia

Study type: Interventional

Funder types: Other

Identifiers

NCT07294352

566/2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Tramadol group

Active Comparator group

Description:

Intrathecal tramadol 20mg + bupivacaine 0.5%

Treatment:

Drug: Intrathecal tramadol with spinal anesthsia

Intrathecal nalbuphine

Experimental group

Description:

Intrathecal nalbuphine 1 mg + bupivacaine 0.5%

Treatment:

Drug: Intrathecal nalbuphine and spinal anesthesia