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

NCT07651488 | Completed Early Phase 1

• 1 other identifier: IRB-App#0792-2022-LNH-ERC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Duration of Analgesia; Pain Score

Outcome Measures

Primary Outcomes (1)

• Duration of analgesia

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

  0 hour to 4 hours

Secondary Outcomes (1)

• Pain score

  Two hours post surgery till 24 hours

Study Arms (2)

Dexemedetomidine

EXPERIMENTAL

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

Drug: Dexmedetomidine

Hyperbaric bupivacaine

ACTIVE COMPARATOR

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

Drug: Hyperbaric bupivacaine % 0.5

Interventions

Dexmedetomidine DRUG

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

Dexemedetomidine

Hyperbaric bupivacaine % 0.5 DRUG

5 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone

Hyperbaric bupivacaine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing elective perianal surgery under spinal saddle block were included in the study.
• Age between 40-80 years
• ASA status I and II

You may not qualify if:

• 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

Sponsors & Collaborators

• Liaquat National Hospital & Medical College: lead

Study Sites (1)

Liaquat National Hospital

Karachi, Pakistan

Location

Related Links

• Effects of Adding Intrathecal Dexmedetomidine to Hyperbaric Bupivacaine for Saddle Spinal Block in Adults Undergoing Peri-anal Surgeries
• Effect Of Dexmedetomidine Added To Intrathecal Hyperbaric Bupivacaine Versus Bupivacaine Alone On Mean Postoperative Analgesia After Spinal Saddle Block
• EFFECT OF ADDING DEXMEDETOMIDINE VERSUS FENTANYL TO INTRATHECAL HYPERBARIC BUPIVACAINE ON SPINAL BLOCK FOR INFRAUMBILICAL ELECTIVE SURGERIES
• Effects of intravenous dexmedetomidine on hyperbaric bupivacaine spinal anesthesia: A randomized study

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2026
• First Posted: June 16, 2026
• Study Start: March 29, 2023
• Primary Completion: September 28, 2023
• Study Completion: September 28, 2023
• Last Updated: June 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)