Pain Outcomes of Non-opioid vs. Opioid Analgesia for Kidney Stone Surgery.

NCT03584373 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 2018-9031
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 2

Brief Summary

There are two options for postoperative pain management: opioid and non-opioid analgesia. Pain outcomes will be compared in patients undergoing ureteroscopy and percutaneous nephrolithotomy by randomly administering opioid and non-opioid analgesia.

Conditions

Nephrolithiasis

Keywords

Pain Outcomes; Ureteroscopy; Percutaneous Nephrolithotomy; Opioids

Outcome Measures

Primary Outcomes (5)

• Satisfaction With Pain Relief

  The patient will be administered a survey and asked to rate satisfaction with pain relief since the time of surgery and being on the assigned medication. Scoring will be on an 11-point ordinal numeric rating scale, with 0 being not satisfied with pain relief, and 10 being well-satisfied. Higher scores are indicative of greater satisfaction with pain relief

  1 week post surgery

• Current Pain Intensity Level

  The patient will be administered a survey and asked to rate their current pain intensity level (1 week post surgery) on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of greater pain intensity.

  1 week post surgery

• Peak Pain Intensity Level

  The patient will be administered a survey and asked to rate the worst/peak pain intensity level since undergoing the surgery. The patient will be asked to rate this worst pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scoring is indicative of worst/peak pain intensity level since the time of surgery

  1 week post surgery

• Average Pain Intensity Level

  The patient will be administered a survey and asked to rate their average pain intensity level since undergoing surgery. The patient will be asked to rate this average pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 being no pain, and 10 being the worst possible pain. Higher scores are indicative of higher average pain intensity.

  1 week post surgery

• Perception of an Acceptable Pain Intensity Level

  The patient will be administered a survey and asked to rate what their perception or belief of an acceptable pain intensity level would be since undergoing the surgery. The patient will be asked to rate this acceptable pain intensity level on an 11-point ordinal numeric rating scale ranging from 0-10, with 0 equaling no pain, and 10 being the worst possible pain. Higher scores are indicative of the patient's belief of an acceptable pain intensity level.

  1 week post surgery

Secondary Outcomes (2)

• Unused Medications - Proportion of Prescribed Pills Unused at 1 Week Post-Surgery

  1 week post surgery

• Rates of Constipation

  1 week post surgery

Study Arms (2)

Non-Opioid Analgesia

EXPERIMENTAL

Ketorolac - Oral; 10 mg tablet: 1 tablet every 6 hours, or as needed. (20 tablets prescribed). Acetaminophen - Oral; patient directed as needed. Not prescribed. Ketorolac and Acetaminophen administered post surgery to compare pain outcomes to that of Percocet.

Drug: Ketorolac Oral Tablet [Toradol]; Drug: Acetaminophen

Opioid Analgesia

ACTIVE COMPARATOR

Percocet - Oral; 5 mg tablet: 1 tablet every 4-6 hours, or as needed. (10 tablets prescribed). Percocet administered post surgery to compare pain outcomes to that of the non-opioid analgesia.

Drug: Oxycodone Acetaminophen

Interventions

Ketorolac Oral Tablet [Toradol] DRUG

Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.

Also known as: Toradol

Non-Opioid Analgesia

Acetaminophen DRUG

Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.

Also known as: Tylenol

Non-Opioid Analgesia

Oxycodone Acetaminophen DRUG

Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.

Also known as: Percocet

Opioid Analgesia

Eligibility Criteria

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

You may qualify if:

• Men and Women age\>18 years old
• Presence of renal or ureteral stones suitable for ureteroscopy or percutaneous nephrolithotomy.
• Uncomplicated ureteroscopy or percutaneous nephrolithotomy

You may not qualify if:

• Pregnant/Breastfeeding/Possibly Pregnant Patients
• Pediatric Patients
• Sensitive or Allergic to Opioids, Ketorolac, or Acetaminophen
• Significant Renal Disease
• Peptic Ulcer Disease
• Chronic Pain and recovering opiate use
• Inability to complete questionnaires
• Non-mobile patients
• Patients on methadone

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (2)

Jack D. Weiler Hospital

The Bronx, New York, 10461, United States

Location

Montefiore Hutchinson Campus

The Bronx, New York, 10461, United States

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Ketorolac; Ketorolac Tromethamine; Acetaminophen; oxycodone-acetaminophen

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Kara Watts, Associate Professor, Department of Urology
• Organization: Montefiore Medical Center

kwatts@montefiore.org

718-920-4531

Study Officials

• Kara L Watts, MD

  Montefiore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be an open label, prospective study of approximately 112 subjects undergoing either ureteroscopy or percutaneous nephrolithotomy. Patients who are eligible and choose to undergo ureteroscopy or percutaneous nephrolithotomy will then be asked if they would like to participate in the study and informed consent will be obtained. Patients will then be randomized to control (opioid analgesia) or non-opioid analgesia groups, and given this medication at discharge.

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: July 12, 2018
• Study Start: July 27, 2018
• Primary Completion: March 23, 2022
• Study Completion: March 23, 2022
• Last Updated: December 18, 2023
• Results First Posted: December 18, 2023

Record last verified: 2023-10

Locations

US (2)