Comparison of Analgesic Efficacy of Intrathecal Levobupivacaine With and Without Oral Tizanidine in Lower Limb Surgeries: A Prospective Randomized Study

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-20

Study Completion Date

2025-08-20

Brief Summary

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Tizanidine, alpha-2 adrenergic receptor agonist, provides analgesic and hemodynamic benefits, which could enhance the efficacy of local anaesthetics. This randomized controlled trial examines the effectiveness of oral tizanidine as an adjunct to intrathecal levobupivacaine for spinal anaesthesia in lower limb surgeries

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Detailed Description

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Conditions

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Tizanididne Levobupicaine Lower Limb Surgery Pain, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Tizanidine group

Group T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery

Group Type EXPERIMENTAL

Tizanidine

Intervention Type DRUG

Group T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery

placebo

No active drug will be given per oral

Group Type PLACEBO_COMPARATOR

Tizanidine

Intervention Type DRUG

Group T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery

Interventions

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Tizanidine

Group T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients aged 18 to 60 years with an ASA grade of I-II, who were scheduled for elective lower limb surgeries with a duration of less than 2 hours and 30 mins.

Exclusion Criteria

* Patients with certain conditions such as pregnancy, coagulopathy, cerebrovascular disease, systemic infections, inability to understand the study protocol, allergy to local anaesthetics, psychiatric disorders affecting evaluation, infection at the injection site, kidney and liver diseases, myelopathy or peripheral neuropathy, spinal stenosis, prior spinal surgeries, raised intracranial pressure, multiple sclerosis, spina bifida, those receiving thromboprophylaxis and refusal to participate in the study were excluded.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No