Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05103410
• Other study ID #: FMASU R 175/2021
• Status: Completed
• Phase: Phase 4
• Start date: November 10, 2021
• Est. completion date: January 10, 2023

Study information

• Verified date: February 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 10, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Hysterotomy

Intervention

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

Locations

Country	Name	City	State
Egypt	Ain Shams University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Total opioid consumption	Total morphine consumption per twenty four hours will be estimated	First 24 hours postoperatively
Secondary	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