Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial

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 Overview

• Status: Completed
• Conditions: Analgesia; Anesthesia; Hysterotomy
• Intervention / Treatment: Drug: ARIPiprazole 30 MG; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Aripiprazole; Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery	Drug: ARIPiprazole 30 MG; Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
PLACEBO_COMPARATOR: Placebo; Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery.	Drug: Placebo; Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid consumption	Total morphine consumption per twenty four hours will be estimated	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	First 24 hours postoperatively

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2021
• Primary Completion (ACTUAL): January 1, 2023
• Study Completion (ACTUAL): January 10, 2023

Study Registration Dates

• First Submitted: October 22, 2021
• First Submitted That Met QC Criteria: October 22, 2021
• First Posted (ACTUAL): November 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Antidepressive Agents; Dopamine Agonists; Dopamine Agents; Serotonin 5-HT1 Receptor Agonists; Serotonin Receptor Agonists; Serotonin 5-HT2 Receptor Antagonists; Serotonin Antagonists; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Aripiprazole
• Other Study ID Numbers: FMASU R 175/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No