Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Phase 4

Completed

• Conditions: Hysterotomy; Analgesia; Anesthesia
• Interventions: Drug: ARIPiprazole 30 MG; Drug: Placebo

• Registration Number: NCT05103410
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-22
• Study First Submitted QC: 2021-10-22
• Study First Posted: 2021-11-02
• Study Start: 2021-11-10
• Primary Completion: 2023-01-01
• Study Completion: 2023-01-10
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

Read More

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 .

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aripiprazole	ARIPiprazole 30 MG	Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
Placebo	Placebo	Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery.

Primary Outcome Measures

Name	Time	Method
First time to analgesic requirement	First 24 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Total opioid consumption	First 24 hours postoperatively	Total morphine consumption per twenty four hours will be estimated
Visual analogue scale (VAS)	First 24 hours postoperatively	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

Trial Locations

Locations (1)

Ain Shams University Hospitals; 🇪🇬 Cairo, Egypt