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Clinical Trials/NCT07651488
NCT07651488CompletedPhase 1

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

Liaquat National Hospital & Medical College1 site in 1 country100 target enrollmentStarted: March 29, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
100
Locations
1
Primary Endpoint
Duration of analgesia

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
40 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Dexemedetomidine

Experimental

Experimental group received intrathecal dexmedetomidine 5 microgram added to 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection

Intervention: Dexmedetomidine (Drug)

Hyperbaric bupivacaine

Active Comparator

Active comparator had 5 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone

Intervention: Hyperbaric bupivacaine % 0.5 (Drug)

Outcomes

Primary Outcomes

Duration of analgesia

Time Frame: 0 hour to 4 hours

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

Secondary Outcomes

  • Pain score(Two hours post surgery till 24 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fahad Ali Tunio

Principal Investigator

Liaquat National Hospital & Medical College

Study Sites (1)

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