NCT05103410

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

November 10, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

1.1 years

First QC Date

October 22, 2021

Last Update Submit

February 3, 2023

Conditions

AnesthesiaAnalgesiaHysterotomy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Total opioid consumption

    First 24 hours postoperatively

  • Visual analogue scale (VAS)

    First 24 hours postoperatively

Study Arms (2)

Aripiprazole

ACTIVE COMPARATOR

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

Drug: ARIPiprazole 30 MG

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ARIPiprazole 30 MGDRUG

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

Aripiprazole
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Hospitals

Cairo, Egypt

Location

Related Publications (1)

  • Alansary AM, Elbeialy MAK. Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Double-blind Placebo-controlled Trial. Clin J Pain. 2024 Jun 1;40(6):341-348. doi: 10.1097/AJP.0000000000001210.

    PMID: 38450551DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 22, 2021

First Posted

November 2, 2021

Study Start

November 10, 2021

Primary Completion

January 1, 2023

Study Completion

January 10, 2023

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations

EG(1)