Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Analgesia; Hysterotomy; Anesthesia

Treatments: Drug: Placebo; Drug: ARIPiprazole 30 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05103410

FMASU R 175/2021

Details and patient eligibility

About

The analgesic effect of perioperative use of aripiprazole has not been fully investigated.

So, this study aims to test the effects of aripiprazole versus placebo in reducing postoperative pain following laparoscopic hysterectomy and to explore the potential side effects.

Enrollment: 80 patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Physical status American Society of Anesthesiologist (ASA) I or II
• Electively scheduled for laparoscopic hysterectomy,

Exclusion criteria

• Patients who refuse to participate
• Body mass index (BMI) > 30
• ASA physical status > II
• Diabetes
• Major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological)
• Coagulation abnormalities
• Pregnancy
• Known hypersensitivity to aripiprazole or contraindications to its use (a psychiatric illness, patients on antidepressants, dementia-related psychosis)
• History of drug addiction or alcohol abuse
• Mental retardation interfering with the evaluation of pain scores or PCA programs .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups, including a placebo group

Aripiprazole

Active Comparator group

Description:

Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery

Treatment:

Drug: ARIPiprazole 30 MG

Placebo

Placebo Comparator group

Description:

Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery.

Treatment:

Drug: Placebo