Comparative study of intrathecal fentanyl vs butorphanol along with heavy levobupivacaine for analgesic efficacy in adult patients undergoing elective infra umbilical surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- To evaluate the duration of sensory and motor block
Study Overview
Brief Summary
Spinal anaesthesia is one of the most common regional anesthetic
techniques used for lower abdominal and lower limb surgeries. Levobupivacaine is a
new long-acting local anesthetic agent.
Aims and Objectives:
To evaluate duration of sensory block with intrathecal 0.5 % levobupivacaine
and 25 µg fentanyl.
To evaluate duration of sensory block with intrathecal 0.5% levobupivacaine
and 250 µg butrophanol.
To evaluate duration of sensory block with intrathecal 0.5% levobupivacaine
and 0.5ml Normal saline.
To compare the duration of sensory block of intrathecal 0.5% levobupivacaine
with fentanyl vs butrophanol vs normal saline.
The present study will be conducted in the department of
Anaesthesiology, G.G.S. Medical College, Faridkot on 180 patients. The patient will
be divided into three groups of 60 each and the drug will be given as per group
allocation. The aims of the study is to compare the effects of both the drugs on time
and duration of sensory and motor block , maximum sensory level achieved, time to
regression of sensory block till S2 dermatome and time to regression of motor block.
The data will then be statistically analyzed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either gender, aged between 18 and 65 years.
- •Patients of American Society of Anesthesiology Grade I and II physical status.
- •Patients scheduled for elective infraumbilical surgery under spinal anaesthesia.
Exclusion Criteria
- •Patients with known allergy to any of the study drugs.
- •All known contraindications to spinal anaesthesia like: o Patients with coagulation disorders and on anticoagulants.
- •o Patients with local skin infection or disease.
- •o Patients with previous spinal surgeries, spine abnormalities.
- •Patient refusal.
Outcomes
Primary Outcomes
To evaluate the duration of sensory and motor block
Time Frame: with in 24hrs postoperatively
Secondary Outcomes
- Need for rescue analgesia(Till the effect of spinal analgesia subsides)
Investigators
Dr Sarvjeet Kaur
Professor, Dept of Anaesthesia