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Completed

NCT Number: NCT05103410

Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

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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Key information

Conditions

Anesthesia Agnosia Analgesia Hysterotomy Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams University Hospitals

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

ARIPiprazole 30 MG

Drug

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

Placebo

Drug

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

Primary outcomes

  1. First time to analgesic requirement

    Time frame: 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 outcomes

  1. Total opioid consumption

    Time frame: First 24 hours postoperatively

    Total morphine consumption per twenty four hours will be estimated

  2. Visual analogue scale (VAS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 2, 2021
Registry last updated
Feb 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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