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A Study to compare the effects of anti hypertensive Clonidine and butorphanol (an opioid) In Lower Limb Surgery Under Anaesthesia through injection at lower back.

A prospective randomized double blind comparative study between levobupivacaine with clonidine and levobupivacaine with butorphanol in lower limb orthopaedic surgery under epidural anaesthesia.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034200
Enrollment
100
Registered
2021-06-11
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: ADMINISTRATION OF LEVOBUPIVACAINE WITH CLONIDINE OR ADMINISTRATION OF LEVOBUPIVACAINE WITH BUTORPHANOL IN LOWER LIMB ORTHOPAEDIC SURGERY UNDER EPIDURAL ANAESTHESIA.: Administration of l

Sponsors

Midnapore medical college and hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with ASA grade I and II. 2. Age group between 18 â?? 60 years 3. Patients with height between 150 to 180 cm and body weight between 50 to 80 kg, BMI between 18 to 24.9 kg/m2 4. Cases undergoing lower limb orthopaedic surgeries under epidural anaesthesia.

Exclusion criteria

Exclusion criteria: 1. Refusal of the patient to give consent. 2. Patients with ASA III and above. 3. Local infection at the site of injection. 4. Patient needed conversion to general anaesthesia after giving epidural block. 5. History of allergy or hypersensitivity to study drugs. 6. Patients with any neuropathy or neurological disorder. 7. Pregnant and lactating patients. 8. Psychiatric disorder. 9. Any patient with cardio respiratory disorder. 10. Any patient with hepato-renal disorder. 11. Any patient with endocrine disorder.

Design outcomes

Primary

MeasureTime frame
To evaluate sensory block and motor block between levobupivacaine with butorphanol and levobupivacaine with clonidine. Timepoint: Onset of sensory block and time taken to reach maximum level will be noted. Highest level will be determined in the mid-clavicular line bilaterally by insensitivity to cold alcohol swab tested every 5 mins till highest level is achieved , then every 15 mins till two segment regression of sensory block. Degree of motor block will be assessed by Modified Bromage score till achievement of highest motor level.

Secondary

MeasureTime frame
1.To compare post- operative analgesia between levobupivacaine with butorphanol and levobupivacaine with clonidine 2.Time taken for first request for rescue analgesia after giving epidural block (VAS score 4) 3.Hemodynamic changes in intraoperative and post- operative period. 4.To evaluate any adverse effects if any. Timepoint: Haemodynamic parameters will be monitored intraoperatively every 5 mins for first 30 mins, then every 10 mins till end of the surgery and also post operatively every 2 hour for first 6 hours and thereafter every 4 hours till 24 hours. Sedation will be assessed by Ramsay sedation score. Post operative analgesia will be evaluated using VAS score at every 2 hours till 6 hours,then every 4 hours till 24 hours post operatively .

Countries

India

Contacts

Public ContactARUN KUMAR MANDI

Midnapore medical college and hospital

debasish77bhar@gmail.com8617753967

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026