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Clinical Trials/CTRI/2023/05/052154
CTRI/2023/05/052154Not yet recruitingNot Applicable

Comparative evaluation of intrathecal hyperbaric levobupivacaine and ropivacaine with fentanyl as adjuvant in elective infraumbilical surgery

Department of Anaesthesiology1 site in 1 country100 target enrollmentStarted: January 5, 2023Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
100
Locations
1
Primary Endpoint
onset and duration of sensory block

Study Overview

Brief Summary

The present study will be conducted in department of Anaesthesiology, GGS medical college and hospital Faridkot on 100 patients scheduled for infraumbilical surgeries under spinal anaesthesia. The patients will be divided into two groups as under:-

Group L- patiens will receive 3.5 ml of drug containing o.5% levobupivacaine and 25 mcg of fentanyl.

Group R- patiens will receive 3.5 ml of drug containing o.75% Ropivacaine and 25 mcg of fentanyl.

After administration of study drug onset of sensory and motor blockade will be assessed. Segmental sensory level of anaesthesia will be assessed by patient s response to pin prick every 2 min till 20 min and then every 10 min till highest level is achieved. time of onset of sensory block will be noted. Time of sensory block regression will be assessed from maximum block height attained to regression till L1 dermatome. Duration of sensory block is defined as time from intrathecal injection to regression of pin prick sensation to L1 dermatome. Motor block will be assessed every 5 min for 30 min and then every 15 min till recovery of motor blockade to modified bromage score of zero. Time of regression of motor block will be assessed from modified bromage score of 3 to zero. Duration of motor block is defined as time from intrathecal injection to regression of motor block to bromage score of zero.Intraoperative pulse rate, mean arterial blood pressure and oxygen saturation will be recorded every 2 min till 20 min and then every 5 min till end of surgery. Any side effects like nausea, vomiting, pruritis, bradycardia or hypotension will be recorded. In the post operative period the time to first analghesic demand will be noted and patient will be given rescue analgesia in the form of injection diclofenac sodium 1.5 mg/kg IV (intravenous) if VAS >3 and requirement of same will be noted for 24 hours. After completion of study, observations obtained will be tabulated and analysed using appropriate statistical methods.

Study Design

Study Type
Interventional
Allocation
Computer generated randomization
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • •American society of anaesthesiology grade I and II patients scheduled for elective infraumbilical surgeries under spinal anaesthesia.

Exclusion Criteria

  • •patients with known allergy to any of the study drugs
  • •patients with coagulation disorders and on anticoagulants
  • •patients with local skin infection or disease
  • •patients with previous spine surgery or spine abnormality.

Outcomes

Primary Outcomes

onset and duration of sensory block

Time Frame: from time of injection of drug till loss of sensation at T6 dermatome which will be checked every 2 minutes till 20 min and then every 10 min till highest level attained

Secondary Outcomes

  • onset and duration of motor block(every 5 minutes for 30 minutes and then every 15 minutes till recovery of motor blockade to modified bromage score of zero)

Investigators

Sponsor
Department of Anaesthesiology
Sponsor Class
Government medical college

Study Sites (1)

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