Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
- Conditions
- Post-Op Complication
- Interventions
- Drug: Bupivacaine-Fentanyl group
- Registration Number
- NCT05596552
- Lead Sponsor
- Ain Shams University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
- ASA physical status I and II
- aged 21-50 years
- scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bupivacaine-Dexmedetomidine group hyperbaric bupivacaine and dexmedetomidine - Bupivacaine-Fentanyl group Bupivacaine-Fentanyl group -
- Primary Outcome Measures
Name Time Method Post-operative urinary retention 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 Outcome Measures
Name Time Method Time to micturition or insertion of an intermittent urinary catheter 6 hours The time from completion of intrathecal injection of the study drug till voiding or insertion of an in-out catheter
Maximum sensory level achieved 30 minutes Sensory level assessment by loss of sensation to pinprick every 2 minutes, until the highest level had stabilized for four consecutive tests
Number of patients who needed an indwelling (Foley's) catheter 6 hours After 6 post-operative hours, if the patient wasn't able to void an indwelling (Foley's) catheter was then placed
Time to reach sensory block at T10 30 minutes 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.
Duration of sensory block 6 hours he time from completion of intrathecal injection of the study drug till regression to the third sacral dermatome (S3) level
The onset of motor block 30 minutes The time from completion of intrathecal injection of the study drug till having a modified Bromage score = 1 or more
Intra-operative fluids given 3 hours The volume of IV Ringer's solution given to each patient according to the fluid chart
Duration of motor block 6 hours 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
Trial Locations
- Locations (1)
Faculty of Medicine
🇪🇬Cairo, Egypt