Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
Primary Purpose
Post-Op Complication
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
hyperbaric bupivacaine and dexmedetomidine
Bupivacaine-Fentanyl group
Sponsored by
About this trial
This is an interventional diagnostic trial for Post-Op Complication
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
- patients with heart block
- diabetic patients
- patients on α2-adrenergic receptors antagonists
- calcium channel blockers
Sites / Locations
- Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bupivacaine-Dexmedetomidine group
Bupivacaine-Fentanyl group
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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
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
Intra-operative fluids given
The volume of IV Ringer's solution given to each patient according to the fluid chart
Duration of sensory block
he time from completion of intrathecal injection of the study drug till regression to the third sacral dermatome (S3) level
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
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
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
Full Information
NCT ID
NCT05596552
First Posted
October 24, 2022
Last Updated
October 24, 2022
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05596552
Brief Title
Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
Official Title
Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
October 15, 2021 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
July 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Op Complication
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bupivacaine-Dexmedetomidine group
Arm Type
Active Comparator
Arm Title
Bupivacaine-Fentanyl group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
hyperbaric bupivacaine and dexmedetomidine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-Fentanyl group
Intervention Description
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
Primary Outcome Measure Information:
Title
Post-operative urinary retention
Description
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
Time Frame
3 hours
Secondary Outcome Measure Information:
Title
Time to reach sensory block at T10
Description
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.
Time Frame
30 minutes
Title
Maximum sensory level achieved
Description
Sensory level assessment by loss of sensation to pinprick every 2 minutes, until the highest level had stabilized for four consecutive tests
Time Frame
30 minutes
Title
The onset of motor block
Description
The time from completion of intrathecal injection of the study drug till having a modified Bromage score = 1 or more
Time Frame
30 minutes
Title
Intra-operative fluids given
Description
The volume of IV Ringer's solution given to each patient according to the fluid chart
Time Frame
3 hours
Title
Duration of sensory block
Description
he time from completion of intrathecal injection of the study drug till regression to the third sacral dermatome (S3) level
Time Frame
6 hours
Title
Duration of motor block
Description
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
Time Frame
6 hours
Title
Time to micturition or insertion of an intermittent urinary catheter
Description
The time from completion of intrathecal injection of the study drug till voiding or insertion of an in-out catheter
Time Frame
6 hours
Title
Number of patients who needed an indwelling (Foley's) catheter
Description
After 6 post-operative hours, if the patient wasn't able to void an indwelling (Foley's) catheter was then placed
Time Frame
6 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
patients with heart block
diabetic patients
patients on α2-adrenergic receptors antagonists
calcium channel blockers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghada M Samir, MD
Organizational Affiliation
Faculty of Medicine, Ain- Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
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