Back to resultsImpact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy
Primary Purpose
Anesthesia, Analgesia, Hysterotomy
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
ARIPiprazole 30 MG
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia
Eligibility Criteria
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 .
Sites / Locations
- Ain Shams University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Aripiprazole
Placebo
Arm Description
Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Total opioid consumption
Total morphine consumption per twenty four hours will be estimated
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
Full Information
NCT ID
NCT05103410
First Posted
October 22, 2021
Last Updated
February 3, 2023
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT05103410
Brief Title
Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy
Official Title
Impact of Preoperative Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy: A Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
November 10, 2021 (Actual)
Primary Completion Date
January 1, 2023 (Actual)
Study Completion Date
January 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Analgesia, Hysterotomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aripiprazole
Arm Type
Active Comparator
Arm Description
Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery.
Intervention Type
Drug
Intervention Name(s)
ARIPiprazole 30 MG
Intervention Description
Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery
Primary Outcome Measure Information:
Title
First time to analgesic requirement
Description
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.
Time Frame
First 24 hours postoperatively
Secondary Outcome Measure Information:
Title
Total opioid consumption
Description
Total morphine consumption per twenty four hours will be estimated
Time Frame
First 24 hours postoperatively
Title
Visual analogue scale (VAS)
Description
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
Time Frame
First 24 hours postoperatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 .
Facility Information:
Facility Name
Ain Shams University Hospitals
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Impact of Aripiprazole on Postoperative Analgesia in Laparoscopic Hysterectomy
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