TizanididnePhase 4NCT07310628
Comparison of Analgesic Efficacy of Intrathecal Levobupivacaine With and Without Oral Tizanidine in Lower Limb Surgeries: A Prospective Randomized Study
A Phase 4 study testing Tizanidine in people with Tizanididne and Levobupicaine, run by All India Institute of Medical Sciences at 1 site in India.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tizanididne, Levobupicaine, Lower Limb Surgery
- What is being tested?
- Tizanidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIndia
- Study dates
- 20 Aug 2022to 20 Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this 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
- Conditions
- Tizanididne, Levobupicaine, Lower Limb Surgery, Pain, Chronic
- Being tested
- Tizanidine
- Keywords
- tizanidine
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TizanidineDrug
Group T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery
| Study group | Role | What they receive |
|---|---|---|
| Tizanidine group | Experimental | Group T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery Receives: Drug: Tizanidine |
| placebo | Placebo comparator | No active drug will be given per oral Receives: Drug: Tizanidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: intraoperative period after the spinal anaesthesia was given
Secondary outcomes (1)
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.
Measured: intraoperative and post operative period up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start20 Aug 2022
- Primary completion10 Jul 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TizanididneStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Science, Raebareli
- Responsible party
- Principal investigator, ADABALA VIJAY BABU, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310628
- Sponsor's protocol ID
- 15
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: if needed the data needed will be shared
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Intrathecal Levobupivacaine With and Without Oral Tizanidine in Lower Limb Surgeries: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07310628
- Acronym / sponsor ID
- 15
- Conditions
- Tizanididne, Levobupicaine, Lower Limb Surgery, Pain, Chronic
- Keywords
- tizanidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- All India Institute of Medical SciencesUniversity, hospital or other
- Collaborators
- All India Institute of Medical Science, Raebareli
- Study start
- 20 Aug 2022 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 30 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tizanidine group | Experimental | Drug: TizanidineGroup T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery |
| placebo | Placebo comparator | Drug: TizanidineNo active drug will be given per oral |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TizanidineGroup T received 3 ml of 0.5% hyperbaric levobupivacaine and 4 mg of oral tizanidine 1 hour before surgery | Drug | Tizanidine group, placebo |
Primary outcome
Onset of action
Time frame: intraoperative period after the spinal anaesthesia was given
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.
1 secondary outcome
pain score
Time frame: intraoperative and post operative period up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Yes. if needed the data needed will be shared
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tizanidine in people with Tizanididne and Levobupicaine, run by All India Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Onset of action (time frame: intraoperative period after the spinal anaesthesia was given). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.