A Phase 4 interventional study of ARIPiprazole 30 MG and Placebo in Anesthesia, Analgesia and Hysterotomy, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-06.
Sponsored by Ain Shams University · Phase 4, Interventional, and Treatment
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.
1,192 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's enrollment of 80 is close to the median of 78 across 1,026 interventional studies indexed under Agnosia.
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Exclusion Criteria:
Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
Drug: ARIPiprazole 30 MG
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 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
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.
Time frame: First 24 hours postoperatively
Total opioid consumption
Total morphine consumption per twenty four hours will be estimated
Time frame: 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
Time frame: First 24 hours postoperatively
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Ain Shams University