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

NCT07310628 | Completed Phase 4

• 1 other identifier: 15
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tizanididne; Levobupicaine; Lower Limb Surgery; Pain, Chronic

Keywords

tizanidine

Outcome Measures

Primary Outcomes (1)

• Onset of action

  The duration of the sensory block was measured using the two-segment regression method, while the time until the first need for pain relief after surgery was used to determine the duration of analgesia. The modified Bromage scale was used to assess motor block. (0 = Ability to flex hips, knees, and ankles without paralysis; 1 = the ability to move the knees but not extend the legs; 2 = ability to flex at the ankles but not the knees; 3 = unable to move any part of the lower limb). The time between the injection and the highest Bromage score was used to determine the onset time of motor block.

  intraoperative period after the spinal anaesthesia was given

Secondary Outcomes (1)

• pain score

  intraoperative and post operative period up to 24 hours

Study Arms (2)

Tizanidine group

EXPERIMENTAL

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

Drug: Tizanidine

placebo

PLACEBO COMPARATOR

No active drug will be given per oral

Drug: Tizanidine

Interventions

Tizanidine DRUG

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

Tizanidine group; placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead
• All India Institute of Medical Sciences, Raebareli, UP: collaborator

Study Sites (1)

Adabala Vijay Babu

Raebareli, Uttar Pradesh, 229405, India

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

tizanidine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ABabu

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 30, 2025
• Study Start: August 20, 2022
• Primary Completion: July 10, 2025
• Study Completion: August 20, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (1)