Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy

• Sponsor: Cairo University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05610384
• Collaborator: (none)
• Enrollment: 100
• Arms: 2
• Anticipated Duration (Months): 3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Hysterectomy	Drug: Ketorolac Injectable Solution; Drug: Ibuprofen 800 mg	N/A

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Intravenous Ibuprofen Versus Ketorolac for Perioperative Pain Control After Open Hysterectomy: a Randomized Controlled Trial
• Anticipated Study Start Date: Nov 1, 2022
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ketorolac group ketorolac 30 mg	Drug: Ketorolac Injectable Solution; ketorolac 30 mg (diluted in 200 mL normal saline) intravenously over 5 minutes before induction of anesthesia then every 8 hours postoperatively
Active Comparator: Ibuprofen group ibuprofen 800 mg	Drug: Ibuprofen 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.

Outcome Measures

Primary Outcome Measures

1. mean dynamic VAS [24 hour after surgery]

   average postoperative VAS

Secondary Outcome Measures

1. 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')

2. 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')

3. time to first analgesia requirement [period from extubation until first analgesic requirement during the first 24 hour postoperatively]

   hours

4. morphine consumption [during the first 24 hour postoperatively]

   mg

5. time to independent movement [during the first 24 hour postoperatively]

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

6. patients satisfaction [at the end of 24 hour postoperative]

   on scale of 0 to 10

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ahmed Hasanin, Principal Investigator, Cairo University
• ClinicalTrials.gov Identifier: NCT05610384
• Other Study ID Numbers: MD-246-2022
• First Posted: Nov 9, 2022
• Last Update Posted: Nov 9, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Ibuprofen; Ketorolac

Study Results

No Results Posted as of Nov 9, 2022