Oral Duloxetine as a Premedication for Postoperative Pain Control

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Anesthesia

Treatments: Drug: Placebo; Drug: Duloxetine 60mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05050656

FMASU R 63/ 2021

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups, including a placebo group

Group D (duloxetine group)

Active Comparator group

Description:

Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.

Treatment:

Drug: Duloxetine 60mg

Group C (control group)

Placebo Comparator group

Description:

Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery.

Treatment:

Drug: Placebo