Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy

Study Overview
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Brief Summary
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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.

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

Conditions
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Anesthesia, Analgesia, Hysterotomy

Intervention / Treatment
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* Drug: ARIPiprazole 30 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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 .

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aripiprazole<br>Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery | Drug: ARIPiprazole 30 MG<br>* Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery<br>|
| Placebo Comparator: Placebo<br>Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery. | Drug: Placebo<br>* Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery<br>|

What is the study measuring?
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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 |