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

Surgery Clinical Trial

Official title:

Low Dose Versus Normal Dose Ketorolac for Postoperative Pain After Prostatectomy and Hysterectomy: a Double-blind Randomized Controlled Non-inferiority Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206110
• Other study ID #: f/2021/129
• Status: Recruiting
• Phase: N/A
• Start date: April 21, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2023
• Source: Jessa Hospital
• Contact: Björn Stessel
• Phone: 003211222107
• Email: bjorn.stessel[@]jessazh.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative
• Surgery

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Belgium	Jessa hospital	Hasselt	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain at rest at PACU, 2, 4, 6, 12, 16 and 24 hours after surgery: Numeric Rating Scale (NRS)	Pain at rest at PACU, 2, 4, 6, 12, 16 and 24 hours after surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)	At PACU, 2, 4, 6, 12, 16 and 24 hours after surgery
Secondary	Pain at movement at PACU, 2, 4, 6, 8, 12, 16 and 24 hours after surgery: Numeric Rating Scale	Pain at movement at PACU, 2, 4, 6, 12, 16 and 24 hours after surgery (measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)	At PACU, 2, 4, 6, 8, 12, 16 and 24 hours after surgery
Secondary	Piritramide consumption at PACU (mg)	Mean total postoperative intravenous piritramide consumption at PACU (milligram)	At PACU until 2 hours after surgery
Secondary	Piritramide consumption first 24 hours postoperative (mg): PCIA pump	Total amount of intravenous piritramide used in the first 24h postoperative. Use of piritramide will be objectified by a patient controlled intravenous analgesia (PCIA) pump. Information on piritramide consumption will be extracted from the PCIA-system and analyzed using 4-hour intervals.	First 24 hours after surgery
Secondary	Quality of sleep during the first postoperative night: Numeric Rating Scale	Quality of sleep during the first postoperative night, as measured by an 11-point NRS (where 0 = no sleep at all, and 10 = sleeping very well)	First postoperative night
Secondary	Patient satisfaction: Numeric Rating Scale	Overall patient satisfaction with pain therapy, as assessed with an 11-point NRS scale (where 0 = not satisfied at all and 10 = extremely satisfied).	1week postoperatively assessed with telephone-call
Secondary	Global Surgical Recovery Index	General health status at that moment, as assessed with a scale (where 0=worst imaginable health status, and 100 = best imaginable health status)	Before surgery (baseline) and 1 week postoperatively assessed with telephone-call
Secondary	EQ-5D	Quality of life concerning mobility, self-care, pain/discomfort and anxiety/depression, as assessed with a score (where 0 = lowest quality of life, and 1 = highest quality of life)	Before surgery (baseline) and 1 week postoperatively assessed with telephone-call
Secondary	Adverse effects of ketorolac use or suspected by the use of ketorolac	Possible adverse effects related to ketolorac are: GI-bleeding, acute kidney failure (defined as an increase in serum creatinine by 1,5), postoperative bleeding (defined as the necessity of packed cells transfusion or surgical relook), allergic reaction and asthma exacerbation.	During study completion, i.e. 1 week after the surgery
Secondary	Fear of the surgical procedure: Surgical fear questionnaire	Fear of the surgical procedure using an 8-item Surgical Fear Questionnaire.	Before surgery (baseline)
Secondary	Expected pain after surgery: Numeric Rating Scale	Expected pain after surgery measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)	Before surgery (baseline)
Secondary	Pain before surgery: Numeric Rating Scale	Pain before surgery measured via an 11-point Numeric Rating Scale where 0 = no pain and 10 is worst pain imaginable)	Before surgery (baseline)