Analgesia, Anesthesia, Hysterotomy
Conditions
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.
Interventions
DRUGARIPiprazole 30 MG
Patients will receive Aripiprazole 30 mg tablet orally 3 h before surgery
DRUGPlacebo
Patients will receive placebo tablet which is identical in appearance, size, shape, and color to aripiprazole 3 h before surgery
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First time to analgesic requirement | First 24 hours postoperatively | 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
| Measure | Time frame | Description |
|---|---|---|
| Total opioid consumption | First 24 hours postoperatively | Total morphine consumption per twenty four hours will be estimated |
| Visual analogue scale (VAS) | First 24 hours postoperatively | 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 |
Countries
Egypt
Outcome results
None listed