Post-Op ComplicationPhase 4NCT05596552
Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
A Phase 4 study testing hyperbaric bupivacaine and dexmedetomidine and Bupivacaine-Fentanyl group in people with Post-Op Complication, run by Ain Shams University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Op Complication
- What is being tested?
- hyperbaric bupivacaine and dexmedetomidine and Bupivacaine-Fentanyl group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2021to 15 Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA physical status I and II
- aged 21-50 years
- scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Post-Op Complication
- Being tested
- hyperbaric bupivacaine and dexmedetomidine, Bupivacaine-Fentanyl group
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hyperbaric bupivacaine and dexmedetomidineDrug
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 groupDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine-Dexmedetomidine group | Active comparator | Not described Receives: Drug: hyperbaric bupivacaine and dexmedetomidine |
| Bupivacaine-Fentanyl group | Active comparator | Not described Receives: Drug: Bupivacaine-Fentanyl group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 hours
Secondary outcomes (8)
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.
Measured: 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
Measured: 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
Measured: 30 minutes
Intra-operative fluids given
The volume of IV Ringer's solution given to each patient according to the fluid chart
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start15 Oct 2021
- Primary completion25 May 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
- Investigators
- Ghada M Samir, MD, Principal investigator, Faculty of Medicine, Ain- Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596552
- Sponsor's protocol ID
- MS532/2021
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intrathecal Dexmedetomidine Versus Fentanyl as Adjuvants to Bupivacaine on Post-operative Urinary Retention in Knee Joint Arthroscopic Surgeries
- ClinicalTrials.gov ID
- NCT05596552
- Acronym / sponsor ID
- MS532/2021
- Conditions
- Post-Op Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine-Dexmedetomidine group | Active comparator | Drug: hyperbaric bupivacaine and dexmedetomidine |
| Bupivacaine-Fentanyl group | Active comparator | Drug: Bupivacaine-Fentanyl group |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ASA physical status I and II
- aged 21-50 years
- scheduled to undergo unilateral arthroscopic knee surgeries under spinal anesthesia
Key exclusion criteria (14 listed)
- Patients' refusal
- contraindications to spinal anesthesia
- patients with coagulopathy
- infection at the lumbar region
- pre-existing neurological deficits in the lower limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hyperbaric bupivacaine and dexmedetomidineIn 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 | Drug | Bupivacaine-Dexmedetomidine group |
| Bupivacaine-Fentanyl groupIn 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 | Drug | Bupivacaine-Fentanyl group |
Primary outcome
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
8 secondary outcomes
Time to reach sensory block at T10
Time frame: 30 minutes
Maximum sensory level achieved
Time frame: 30 minutes
The onset of motor block
Time frame: 30 minutes
Intra-operative fluids given
Time frame: 3 hours
Duration of sensory block
Time frame: 6 hours
Duration of motor block
Time frame: 6 hours
Time to micturition or insertion of an intermittent urinary catheter
Time frame: 6 hours
Number of patients who needed an indwelling (Foley's) catheter
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Post-Op Complication
Recruiting
Endo-SPONGE for Treatment of Anastomotic or Hartmann's Stump Leakages in Lower Pelvic Area
Anastomotic Leaks, Hartmanns Stump Leakage
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ghada M Samir, MD principal investigator
Faculty of Medicine, Ain- Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hyperbaric bupivacaine and dexmedetomidine and Bupivacaine-Fentanyl group in people with Post-Op Complication, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative urinary retention (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.