Clinical trial NCT05610384: Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy
Official title: Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Hysterectomy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: mean dynamic VAS
timeFrame: 24 hour after surgery
Secondary outcomes:
measure: static VAS
timeFrame: 30 minutes, 2, 4, 6, 10, 18, 24 hours postoperatively
measure: dynamic VAS
timeFrame: procedure (during knee flexion)
measure: time to first analgesia requirement
timeFrame: period from extubation until first analgesic requirement during the first 24 hour postoperatively
measure: morphine consumption
timeFrame: during the first 24 hour postoperatively
measure: time to independent movement
timeFrame: during the first 24 hour postoperatively
measure: patients satisfaction
timeFrame: at the end of 24 hour postoperative
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ahmed Mohamed Hasanin
Study officials:
References: