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

NCT ID: NCT07294352

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-08-01

Brief Summary

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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

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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.

Conditions

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Adjuvants, Anesthesia Subarachnoid Block

Keywords

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Subarachnoid block Adjuvants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tramadol group

Intrathecal tramadol 20mg + bupivacaine 0.5%

Group Type ACTIVE_COMPARATOR

Intrathecal tramadol with spinal anesthsia

Intervention Type DRUG

intrathecal tramadol 20mg with Hyperbaric 0.5% bupivacaine

Intrathecal nalbuphine

Intrathecal nalbuphine 1 mg + bupivacaine 0.5%

Group Type EXPERIMENTAL

Intrathecal nalbuphine and spinal anesthesia

Intervention Type DRUG

intrathecal nalbuphine 1mg with 0.5% Hyperbaric Bupivacaine

Interventions

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Intrathecal tramadol with spinal anesthsia

intrathecal tramadol 20mg with Hyperbaric 0.5% bupivacaine

Intervention Type DRUG

Intrathecal nalbuphine and spinal anesthesia

intrathecal nalbuphine 1mg with 0.5% Hyperbaric Bupivacaine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CMH Lahore Medical College and Institute of Dentistry

OTHER

Sponsor Role lead

Responsible Party

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Khadija Zubair

Dr. Khadija Zubair

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Khadija Zubair, MBBS

Role: CONTACT

Phone: +923211403262

Email: [email protected]

References

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Sharma A, Chaudhary S, Kumar M, Kapoor R. Comparison of nalbuphine versus fentanyl as intrathecal adjuvant to bupivacaine for orthopedic surgeries: A randomized controlled double-blind trial. J Anaesthesiol Clin Pharmacol. 2021 Oct-Dec;37(4):529-536. doi: 10.4103/joacp.JOACP_270_18. Epub 2022 Jan 6.

Reference Type BACKGROUND
PMID: 35340949 (View on PubMed)

Other Identifiers

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566/2024

Identifier Type: -

Identifier Source: org_study_id