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Clinical Trials/NCT05596552
NCT05596552
Completed
Phase 4

Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries

Ain Shams University1 site in 1 country70 target enrollmentOctober 15, 2021

Overview

Phase
Phase 4
Intervention
hyperbaric bupivacaine and dexmedetomidine
Conditions
Post-Op Complication
Sponsor
Ain Shams University
Enrollment
70
Locations
1
Primary Endpoint
Post-operative urinary retention
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The aim of this study was to assess the effect of intrathecally injected 5 µg dexmedetomidine or 25 µg fentanyl as adjuvants to bupivacaine in low dose spinal anesthesia for unilateral arthroscopic knee surgeries, on post-operative urinary retention (POUR), time needed to reach sensory block at the tenth thoracic dermatome (T10), the maximum sensory level achieved, the onset of motor block, the intra-operative fluids given, the duration of sensory and motor blocks, time to micturition or insertion of an intermittent urinary catheter and the number of patients who needed an indwelling (Foley's) catheter. Seventy patients, ASA physical status I or II, from 21 to 50 years old, scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia, were randomly divided into two equal groups; the Bupivacaine- Dexmedetomidine group (BD) patients and the Bupivacaine-Fentanyl group (BF) patients.

Registry
clinicaltrials.gov
Start Date
October 15, 2021
End Date
July 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ghada M.Samir

Assistant Professor of Anesthesia

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • ASA physical status I and II
  • aged 21-50 years
  • scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia

Exclusion Criteria

  • Patients' refusal
  • contraindications to spinal anesthesia
  • patients with coagulopathy
  • infection at the lumbar region
  • pre-existing neurological deficits in the lower limbs
  • known allergy to any of the study drugs
  • urinary incontinence
  • cysto-ureteric reflux
  • patients with congestive heart failure
  • patients with dysrhythmia

Arms & Interventions

Bupivacaine-Dexmedetomidine group

Intervention: hyperbaric bupivacaine and dexmedetomidine

Bupivacaine-Fentanyl group

Intervention: Bupivacaine-Fentanyl group

Outcomes

Primary Outcomes

Post-operative urinary retention

Time Frame: 3 hours

Ultrasound assessment of the urinary bladder volume was done at the 3rd post-operative hour, a bladder volume of \>700 ml with no ability to void confirmed the presence of urinary retention

Secondary Outcomes

  • Time to micturition or insertion of an intermittent urinary catheter(6 hours)
  • Maximum sensory level achieved(30 minutes)
  • Number of patients who needed an indwelling (Foley's) catheter(6 hours)
  • Time to reach sensory block at T10(30 minutes)
  • Duration of sensory block(6 hours)
  • The onset of motor block(30 minutes)
  • Intra-operative fluids given(3 hours)
  • Duration of motor block(6 hours)

Study Sites (1)

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