Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2023-01-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Anesthesia Analgesia Hysterotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Aripiprazole

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

Group Type ACTIVE_COMPARATOR

ARIPiprazole 30 MG

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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ARIPiprazole 30 MG

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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 .

Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No