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Completed

NCT Number: NCT05050656

Oral Duloxetine as a Premedication for Postoperative Pain Control

The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.

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Key information

Conditions

Anesthesia

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

faculty of medicine, Ain Shams University

Cairo, 11591, Egypt

About this study

We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists I or II.
  • Sex: Both sexes.
  • Age between 18 and 50.
  • Height 155-180 cm.
  • Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia.

Exclusion criteria

  • Declining to give written informed consent.
  • History of allergy to the medications used in the study.
  • Had a history of drug or alcohol abuse.
  • Taking opioids or sedative medications.
  • Inability to communicate with patients to evaluate the postoperative pain.
  • Need for postoperative ICU hospitalization.
  • Hepatic or renal failure.
  • Patients with a history of taking duloxetine or any SSRIs.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • Psychiatric disorders with antipsycotics or antidepressants (tricylic or MAOIs).
  • Antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
  • Quinolones (ciprofloxacin).

Treatment and study plan

Duloxetine 60mg

Drug

Duloxetine is a selective SNRI prescribed in depression, anxiety, and chronic pain like diabetic neuropathy and fibromyalgia, it acts through central and peripheral pain modulation

Placebo

Drug

placebo tablets identical to duloxetine tablets

Primary outcomes

  1. Assess the onset of spinal anesthesia

    Time frame: 20 min

    Time to T10 sensory block and time to Bromage 1 motor block

Secondary outcomes

  1. Duration of spinal anesthesia

    Time frame: 4 hours

    Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery

  2. Postoperative pain

    Time frame: 24 hours

    Will be assessed by the patient using the visual analog scale (VAS, 0=no pain; 10=worst possible pain) every 4hrs up to 24hrs after the operation.

  3. Time for first postoperative rescue analgesia request, frequency, and total morphine consumption

    Time frame: 24 hours

    All participants will receive intravenous paracetamol, one gram every 8hrs, VAS score of 4 or more will receive 3 mg morphine intravenously and not be repeated more frequently than 4hrs limited to 12 mg morphine per 24hrs after operation

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

"Preoperative Oral Duloxetine: Does it Affect Duration of Spinal Anesthesia and Early Postoperative Pain After Arthroscopic ACL Repair?" a Prospective, Randomized, Double-blind Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Sep 20, 2021
Registry last updated
Sep 20, 2021

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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