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

Post-Op Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05596552
• Other study ID #: MS532/2021
• Status: Completed
• Phase: Phase 4
• Start date: October 15, 2021
• Est. completion date: July 15, 2022

Study information

• Verified date: October 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 15, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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 a2-adrenergic receptors antagonists
• calcium channel blockers

Related Conditions & MeSH terms

• Post-Op Complication
• Postoperative Complications
• Urinary Retention

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Intra-operative fluids given	The volume of IV Ringer's solution given to each patient according to the fluid chart	3 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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