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

NCT05206110 | Completed

• 1 other identifier: f/2021/129
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Surgery

Keywords

Ketolorac; Dosage

Outcome Measures

Primary Outcomes (1)

• Pain at rest 8 hours after surgery: Numeric Rating Scale (NRS)

  Pain at rest 8 hours after surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)

  At 8 hours after surgery

Secondary Outcomes (12)

• Pain at rest at PACU, 2, 4, 6, 12, 16 and 24 hours after surgery: Numeric Rating Scale (NRS)

  At PACU, 2, 4, 6, 12, 16 and 24 hours after surgery

• Pain at movement at PACU, 2, 4, 6, 8, 12, 16 and 24 hours after surgery: Numeric Rating Scale

  At PACU, 2, 4, 6, 8, 12, 16 and 24 hours after surgery

• Piritramide consumption at PACU (mg)

  At PACU until 2 hours after surgery

• Piritramide consumption first 24 hours postoperative (mg): PCIA pump

  First 24 hours after surgery

• Quality of sleep during the first postoperative night: Numeric Rating Scale

  First postoperative night

Study Arms (2)

Peri- and postoperative 10 mg Ketolorac

EXPERIMENTAL

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

Drug: 10 mg IV ketorolac

Peri- and postoperative standard-dose 30 mg Ketolorac

ACTIVE COMPARATOR

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

Drug: 30 mg IV ketorolac

Interventions

10 mg IV ketorolac 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 10 mg Ketolorac

30 mg IV ketorolac 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

Peri- and postoperative standard-dose 30 mg Ketolorac

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (1)

Jessa hospital

Hasselt, Limburg, 3500, Belgium

Location

MeSH Terms

Interventions

Ketorolac

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients participating in the study, the surgeons, the researchers assessing the different outcome parameters and the data managers will all be blinded for group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: January 25, 2022
• Study Start: April 21, 2022
• Primary Completion: September 5, 2024
• Study Completion: December 31, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)