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

A

All India Institute of Medical Sciences

Status and phase

Completed
Phase 4

Conditions

Levobupicaine
Pain, Chronic
Lower Limb Surgery
Tizanididne

Treatments

Drug: Tizanidine

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

64 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

64 participants in 2 patient groups, including a placebo group

Tizanidine group
Experimental group
Description:
Group T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery
Treatment:
Drug: Tizanidine
placebo
Placebo Comparator group
Description:
No active drug will be given per oral
Treatment:
Drug: Tizanidine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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