Low Dose Versus Normal Dose Ketorolac for Postoperative Pain After Prostatectomy and Hysterectomy

NCT ID: NCT05206110

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-21
• Study Completion Date: 2024-12-31

Brief Summary

A monocenter, prospective, double-blind, randomized controlled non-inferiority trial will be designed to investigate if ketorolac 10 mg is as effective for pain relief as the standard dose of 30 mg in patients undergoing robot assisted radical prostatectomy (RARP) or hysterectomy by laparoscopic assisted vaginal hysterectomy (LAVH) or total laparoscopic hysterectomy (TLH). It is hypothesised that the postoperative pain score at rest at 8 hours after surgery when receiving ketolorac 10 mg is non-inferior to the pain score at rest when receiving ketolorac 30mg.

Detailed Description

Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), is a commonly used and effective drug for moderate to severe postoperative pain. It is widely prescribed as one of the first steps in acute and postoperative pain since decades. Because of its non-opioid character, this type of drug is safe concerning the risk of addiction and respiratory depression in the postoperative setting, but other side-effects are well known.

Gastro-intestinal (GI) haemorrhage is the most feared complication. The risk of a GI-bleeding increases with age, higher doses and longer duration of therapy. Decrease in renal function seems less important than always assumed. Feldman et al proved that developing renal failure with the use of NSAIDs was rather rare (1,1%) and similar for ketorolac as for opioids. Nonetheless, the risk again increased in a linear fashion with the duration of use. Especially for the postoperative and trauma patient, the fear of platelet inhibition and subsequent bleeding has dominated restriction of its use. Other adverse effects of ketorolac, i.e. cardiovascular toxicity, asthma, allergic reaction, etc., are usually less of a concern for the physician.

In an attempt to reduce these unwanted side effects but still have the benefit of its highly effective analgesic activity, patients should be given the lowest effective dose. Several studies have already demonstrated that ketorolac analgesic efficacy at 10 mg is similar to that at higher doses due to a ceiling effect. Unfortunately, none of the published trials investigated pain scores of the alternative dose beyond 6 hours. Based on the pharmacokinetics of ketorolac, it is possible that the lower dose will loose its analgesic effect after a shorter period. To investigate whether this alternative dose of ketorolac will preserve its analgesic efficacy up to eight hours postoperative, the primary goal of this study will be the pain score after 8 hours, right before the next dose of ketorolac.

Conditions

Anesthesia; Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Peri- and postoperative 10 mg Ketolorac

Patients undergoing LAVH, RARP or TLH will receive dosages of 10 mg ketolorac (IV).

Group Type: EXPERIMENTAL

10 mg IV ketorolac

Intervention Type: DRUG

Patients undergoing LAVH, RARP or TLH will receive half an hour before the end of surgery, 10 mg ketorolac (IV). Also, 10 mg IV ketorolac will be given 8h and 16h after the surgery

Peri- and postoperative standard-dose 30 mg Ketolorac

Patients undergoing LAVH, RARP or TLH will receive standard dosages of 30 mg ketolorac (IV).

Group Type: ACTIVE_COMPARATOR

30 mg IV ketorolac

Intervention Type: DRUG

Patients undergoing LAVH, RARP or TLH will receive half an hour before the end of surgery, 30 mg ketorolac (IV). Also, 30 mg ketorolac will be given 8h and 16h after the surgery

Interventions

10 mg IV ketorolac

Patients undergoing LAVH, RARP or TLH will receive half an hour before the end of surgery, 10 mg ketorolac (IV). Also, 10 mg IV ketorolac will be given 8h and 16h after the surgery

Intervention Type: DRUG

30 mg IV ketorolac

Patients undergoing LAVH, RARP or TLH will receive half an hour before the end of surgery, 30 mg ketorolac (IV). Also, 30 mg ketorolac will be given 8h and 16h after the surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients between 18 and 70 years
• Patients undergoing RARP, LAVH or TLH
• ASA 1-3
• Scheduled as inpatient surgery (at least 1 night)
• Body weight > 60 kg

Exclusion Criteria

• Refusal of the patient
• Cognitive impairment or no understanding of the Dutch language
• Allergy for salicylates or NSAID
• Pregnancy
• Active or history of peptic ulcer disease
• History of gastro-intestinal hemorrhage or perforation
• History of gastric bypass
• History of renal disease with creatinine > 1 mg/dl
• Haematological disease
• Tromboctopenia < 150000 / µl
• Current anticoagulant use
• Current clopidogrel use
• History of substance abuse or use of medication with a suppressive effect on the central nervous system

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jessa Hospital

OTHER

Sponsor Role: lead

Responsible Party

Stessel Björn

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jessa hospital

Hasselt, Limburg, Belgium

Countries

Belgium

Other Identifiers

f/2021/129

Identifier Type: -

Identifier Source: org_study_id