Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Ain Shams University80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Anesthesia Analgesia Hysterotomy

Interventions

ARIPiprazole 30 MGDRUG

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

PlaceboDRUG

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

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 65 Years

Medical Language ↔ Plain English

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 .

Locations (1)

Ain Shams University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

First time to analgesic requirement

After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser Plus® 100 ml, Woo Young Medical Co, Korea) will be prepared with 60 ml normal saline containing 60 mg morphine, it will be programmed to give and 0.5 ml bolus dose with lockout interval of 8 minutes. Time to first Bolus will be estimated considering extubation time is the zero time.

Time frame: First 24 hours postoperatively

Secondary Outcomes

Total opioid consumption

Total morphine consumption per twenty four hours will be estimated

Time frame: First 24 hours postoperatively

Visual analogue scale (VAS)

Pain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU, and 10, 20, 30 minutes, 1 h, 2h, 4, 6, 8, 10, 12, 16 and 24 hr thereafter using visual analogue scale (VAS) (0-10 cm: 0 = no pain, 10 = the worst pain possible). The patients will be instructed about usage of VAS preoperatively

Time frame: First 24 hours postoperatively

Data from ClinicalTrials.gov

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