Evaluation of Intrathecal Hyperbaric Bupivacaine With Dexmedetomidine in Adults Undergoing Perianal Surgery

Early Phase 1CompletedNCT07651488

Liaquat National Hospital & Medical College100 enrolled

Overview

The aim of this study is to evaluate the effects of adding 5-mcg dexmedetomidine to hyperbaric bupivacaine in our population as it has never been published before, to enhance the duration of analgesia after perianal procedures requiring spinal saddle block and, thus reducing requirements of postoperative analgesics.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Duration of Analgesia Pain Score

Interventions

DexmedetomidineDRUG

dexmedetomidine 5 microgram added to 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection

Hyperbaric bupivacaine % 0.5DRUG

5 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing elective perianal surgery under spinal saddle block were included in the study. * Age between 40-80 years * ASA status I and II Exclusion Criteria: * Pregnant women * Patient with coagulopathy * Infection at or near the needle insertion site * Allergy to the trial drug * Patient with chronic pain * Cognitive impairment * Patient with known drug or substance abuse

Locations (1)

Liaquat National Hospital

Karachi, Pakistan

Outcomes

Primary Outcomes

Duration of analgesia

duration of analgesia was assessed from induction of anesthesia till patient discharge

Time frame: 0 hour to 4 hours

Secondary Outcomes

Pain score

Pain will be assessed using Numeric Rating Scale (NRS) scale ranging from 0-10; 0 being no pain and 10 indicates the worst pain

Time frame: Two hours post surgery till 24 hours

Data from ClinicalTrials.gov

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