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Completed

NCT Number: NCT05596552

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.

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Key information

Conditions

Post-Op Complication Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine

Cairo, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperbaric bupivacaine and dexmedetomidine

Drug

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

Drug

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 outcomes

  1. 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

Secondary outcomes

  1. Time to reach sensory block at T10

    Time frame: 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.

  2. Maximum sensory level achieved

    Time frame: 30 minutes

    Sensory level assessment by loss of sensation to pinprick every 2 minutes, until the highest level had stabilized for four consecutive tests

  3. The onset of motor block

    Time frame: 30 minutes

    The time from completion of intrathecal injection of the study drug till having a modified Bromage score = 1 or more

  4. Intra-operative fluids given

    Time frame: 3 hours

    The volume of IV Ringer's solution given to each patient according to the fluid chart

  5. Duration of sensory block

    Time frame: 6 hours

    he time from completion of intrathecal injection of the study drug till regression to the third sacral dermatome (S3) level

  6. Duration of motor block

    Time frame: 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

  7. Time to micturition or insertion of an intermittent urinary catheter

    Time frame: 6 hours

    The time from completion of intrathecal injection of the study drug till voiding or insertion of an in-out catheter

  8. Number of patients who needed an indwelling (Foley's) catheter

    Time frame: 6 hours

    After 6 post-operative hours, if the patient wasn't able to void an indwelling (Foley's) catheter was then placed

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 27, 2022
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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