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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07651488
Acronym
DEX-BUP
Enrollment
100
Registered
2026-06-16
Start date
2023-03-29
Completion date
2023-09-28
Last updated
2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Duration of Analgesia, Pain Score

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.

Interventions

DRUGDexmedetomidine

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

5 mg of 0.5% hyperbaric bupivacaine in dextrose injection alone

Sponsors

Liaquat National Hospital & Medical College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Duration of analgesia0 hour to 4 hoursduration of analgesia was assessed from induction of anesthesia till patient discharge

Secondary

MeasureTime frameDescription
Pain scoreTwo hours post surgery till 24 hoursPain will be assessed using Numeric Rating Scale (NRS) scale ranging from 0-10; 0 being no pain and 10 indicates the worst pain

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026