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Completed

NCT Number: NCT05610384

Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

The aim of this study is to compare the analgesic effect of intravenous ibuprofen to ketorolac for pain control after open hysterectomy

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Key information

Age range

40 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ahmed Mohamed Hasanin

Cairo, 11432, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac Injectable Solution

Drug

ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively

Ibuprofen 800 mg

Drug

ibuprofen 800 mg intravenously (Diluted in 200 mL of normal saline) over 5 minutes before induction of anesthesia then every 8 hours postoperatively.

Primary outcomes

  1. mean dynamic VAS

    Time frame: 24 hour after surgery

    average postoperative VAS

Secondary outcomes

  1. static VAS

    Time frame: 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')

  2. dynamic VAS

    Time frame: 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')

  3. time to first analgesia requirement

    Time frame: period from extubation until first analgesic requirement during the first 24 hour postoperatively

    hours

  4. morphine consumption

    Time frame: during the first 24 hour postoperatively

    mg

  5. time to independent movement

    Time frame: during the first 24 hour postoperatively

    time from extubation to be able independently mobile e.g. using the bathroom

  6. patients satisfaction

    Time frame: at the end of 24 hour postoperative

    on scale of 0 to 10

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Nov 9, 2022
Registry last updated
Jul 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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