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

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

Study Overview

• Status: Completed
• Conditions: Pain, Chronic; Lower Limb Surgery; Tizanididne; Levobupicaine
• Intervention / Treatment: Drug: Tizanidine

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Uttar Pradesh
    • Raebareli, Uttar Pradesh, India, 229405
      • Adabala Vijay Babu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score	Intraoperatively patients' Visual Analog Scale (VAS) scores were assessed. Post operatively VAS score will be assessed in PACU every 4th hourly up to 24 hours . The time to the first analgesic requirement was recorded, with tramadol (100 mg) administered when VAS scores exceeded 4. VAS score 0 is no pain and 10 is intense pain.	intraoperative and post operative period up to 24 hours

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences
• Collaborators: All India Institute of Medical Sciences, Raebareli, UP

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2022
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): August 20, 2025

Study Registration Dates

• First Submitted: November 19, 2025
• First Submitted That Met QC Criteria: December 20, 2025
• First Posted (Estimated): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: tizanidine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain; tizanidine
• Other Study ID Numbers: 15 (Tishreen_University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: if needed the data needed will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No