Postoperative Pain, Hysterectomy
Conditions
Brief summary
The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy
Detailed description
Thirty minutes before the surgery, all patients will receive 1 gm paracetamol intravenously then every 6 hours postoperatively. A research assistant is responsible for opening the envelopes, group assignment and drug preparation (the three doses will be prepared and marked with the patient's name as well as the time of administration) without any further involvement in the study. The patient, attending anesthetist, nurse and data collector will be blinded to the administered drug. Upon arrival to the operating room, routine monitors (electrocardiogram, pulse oximetry, and non-invasive blood pressure monitor) will be applied; intravenous line will be secured, and prophylactic antiemetic will be provided in the form of slow intravenous injection of 8 mg dexamethasone drugs. Anesthesia Anesthesia will be induced with 2 mg/kg propofol, 1 mcg/kg fentanyl, and tracheal intubation will be facilitated by 0.5 mg/kg atracurium after loss of consciousness. Anesthesia will be maintained with isoflurane 1-1.2% in oxygen and 0.1 mg/kg atracurium every 20 minutes. Intraoperative analgesia will be in the form of 1 mcg/kg fentanyl boluses as needed. Postoperatively, pain assessments using the visual analogue scale (VAS) will be performed at rest and during movement (knee flexion) at 0.5, 2, 4, 6, 10, 18, and 24 h after leaving the operating room. If the VAS score is \> 3 intravenous titration of 2 mg morphine given slowly to be repeated after 30 minutes if pain persisted. Intravenous ondansetron 4 mg will be given to treat postoperative nausea or vomiting
Interventions
ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively
DRUGIbuprofen 800 mg
ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* adult (40-65 years) * ASA I-II women * scheduled to undergo open elective abdominal hysterectomy with or without salpingo-oophorectomy
Exclusion criteria
* renal impairment, * allergy to any of study's drugs, * history of gastrointestinal bleeding or ulceration, or inflammatory bowel disease, * severe cardiac comorbidity (impaired contractility with ejection fraction \< 50%, heart block, significant arrhythmias, tight valvular lesions), * patients undergoing surgery for suspected gynaecological cancer, * patients on chronic analgesic medication, * inability to comprehend the Visual Analogue Pain Scoring Scale
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mean dynamic VAS | 24 hour after surgery | average postoperative VAS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| dynamic VAS | procedure (during knee flexion) | a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') |
| time to first analgesia requirement | period from extubation until first analgesic requirement during the first 24 hour postoperatively | hours |
| static VAS | 30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively | a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be') |
| time to independent movement | during the first 24 hour postoperatively | time from extubation to be able independently mobile e.g. using the bathroom |
| patients satisfaction | at the end of 24 hour postoperative | on scale of 0 to 10 |
| morphine consumption | during the first 24 hour postoperatively | mg |
Countries
Egypt
Outcome results
None listed