Use of two different drungs as adjuvant to levobupivacaine for spinal anaesthesia in lower limb surgeries.

Completed

• Conditions: Injuries to the hip and thigh, (2) ICD-10 Condition: S80-S89||Injuries to the knee and lower leg, (3) ICD-10 Condition: S90-S99||Injuries to the ankle and foot,

• Registration Number: CTRI/2019/02/017756
• Lead Sponsor: IMS BHU

Brief Summary

The study will be conducted in Department of Anaesthesiology, IMS, BHU,Varanasi after obtaining written and informed consent and institutional ethical approval. After CTRI registration, 135 patients undergoing lower limb surgeries, age 18 to 60 years will be included. Patients will be excluded from study if patients with local infection or significant coagulopathy, severe cardiopulmonary disease, long term opioid use or with peripheral neuropathies and patient refusal. Patient will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelop technique into three equal groups.

Group (L) will receive 15 mg 0.5% hyperbaric Levobupivacaine plus 0.5 ml 0.9 N Normal saline intrathecally.

Group (N) will receive 15 mg 0.5% hyperbaric Levobupivacaine plus 0.8 mg nalbuphine intrathecally.

Group (M)  will receive 15 mg 0.5% hyperbaric Levobupivacaine plus 100 mg magnesium sulphate intrathecally.



After subarachnoid blockade the patients will be placed in supine position.

The dermatome level of sensory blockade will be evaluated bilaterally along the midclavicular line by using analgesia to pinprick with a short bevelled 27- guage needle. Motor block will be evaluated in the lower limb according to  a Modified Bromage scale. Motor and sensory block will be recorded at 1,3,5,10,15,20,30 and 60 minutes as well as every 60 minute thereafter until resolution of the block.

Onset time to level of sensory block, time to maximum sensory block, time to two segment regression of sensory block, time to full recovery of sensory block and time for recovery of motor block will be recorded.

The study will end at 24 hour of subarachnoid blockade after all data has been obtained.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-03
• Study Completion: 2020-07-31
• Last Update Posted: 2021-03-06

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 135

Inclusion Criteria

ASA Grade 1, 2 Patients scheduled to have various lower limb sugeries.

Exclusion Criteria

• Patient who refuse to participate in study.
• Patients not opting for subarachnoid block as anaesthetic technique.
• Patients with local infection or significant coagulopathy.
• Patients with severe cardiopulmonary disease.
• Patients with blood volume deficit.
• Patients with allergy to local anaesthetics or study drugs.
• Patients with Peripheral Neuropathies,scoliosis.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Level of Sensory blockade	Minutes 1,3,5,10,15,20,30 and 60.

Secondary Outcome Measures

Name	Time	Method
Full recovery of Sensory blockade	Hours 6 and 12.

Trial Locations

Locations (1)

Trauma Centre; 🇮🇳 Varanasi, UTTAR PRADESH, India

Trauma Centre

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Savita kumari

Principal investigator

9807777367

savi568smile@gmail.com