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

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.

Study Overview

• Status: Completed
• Conditions: Post-Op Complication
• Intervention / Treatment: Drug: hyperbaric bupivacaine and dexmedetomidine; Drug: Bupivacaine-Fentanyl group

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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
• patients with heart block
• diabetic patients
• patients on α2-adrenergic receptors antagonists
• calcium channel blockers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bupivacaine-Dexmedetomidine group	Drug: hyperbaric bupivacaine and dexmedetomidine; In a 3 ml syringe, 5 µg dexmedetomidine was added to the 2 ml of 10 mg hyperbaric bupivacaine, to have a total volume of 2.5 ml for intrathecal spinal injection over 3 minute without barbotage
Active Comparator: Bupivacaine-Fentanyl group	Drug: Bupivacaine-Fentanyl group; In a 3 ml syringe, 25 μg fentanyl was added to the 2 ml of 10 mg hyperbaric bupivacaine, to have a total volume of 2.5 ml for intrathecal spinal injection over 3 minute without barbotage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative urinary retention	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	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to reach sensory block at T10	The time from completion of intrathecal injection of the study drug till loss of sensation to pin prick at T10 on the operative side, assessed every 2 minutes.	30 minutes
Maximum sensory level achieved	Sensory level assessment by loss of sensation to pinprick every 2 minutes, until the highest level had stabilized for four consecutive tests	30 minutes
The onset of motor block	The time from completion of intrathecal injection of the study drug till having a modified Bromage score = 1 or more	30 minutes
Intra-operative fluids given	The volume of IV Ringer's solution given to each patient according to the fluid chart	3 hours
Duration of sensory block	he time from completion of intrathecal injection of the study drug till regression to the third sacral dermatome (S3) level	6 hours
Duration of motor block	The time from completion of intrathecal injection of the study drug till complete recovery of the motor function (MBS = 0), by asking the patient to flex the hip, knee and ankle joints, in the PACU, then every 15 minutes in the ward	6 hours
Time to micturition or insertion of an intermittent urinary catheter	The time from completion of intrathecal injection of the study drug till voiding or insertion of an in-out catheter	6 hours
Number of patients who needed an indwelling (Foley's) catheter	After 6 post-operative hours, if the patient wasn't able to void an indwelling (Foley's) catheter was then placed	6 hours

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Ghada M Samir, MD, Faculty of Medicine, Ain- shams University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): July 15, 2022

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Urination Disorders; Postoperative Complications; Urinary Retention; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Dexmedetomidine; Bupivacaine
• Other Study ID Numbers: MS532/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No