Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Sponsor
Ain Shams University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05103410
Collaborator
(none)
80
1
2
11.3
7.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: ARIPiprazole 30 MG
  • Drug: Placebo
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial
Actual Study Start Date :
Oct 21, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. First time to analgesic requirement [First 24 hours postoperatively]

    After extubation, an intravenous patient-controlled analgesia system, will be connected to the patient (Accufuser PlusĀ® 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

  1. Total opioid consumption [First 24 hours postoperatively]

    Total morphine consumption per twenty four hours will be estimated

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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 .

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University Hospitals Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amin Mohammed Alansary Amin Ahmed Helwa, Associate Professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05103410
Other Study ID Numbers:
  • FMASU R 175/2021
First Posted:
Nov 2, 2021
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 8, 2022