Pre-induction Analgesia: Multimodel Regimen vs Aceteminophen for Post Ureteroscopy Pain

NCT03549611 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 201805826
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Adult patients with kidney stones undergoing surgical intervention with ureteroscopy with laser lithotripsy will be randomized to receive one of two different regimens of oral medications administered prior to induction of general anesthesia. Postoperatively, patients will receive automated daily text messages to assess pain and opioid consumption and subsequently determine which which treatment regimen is superior.

Conditions

Kidney Calculi; Pain, Postoperative

Keywords

ureteroscopy; opioids; narcotics; text messaging; real time data acquisition; ecologic momentary assessments; pre-emptive analgesia; gabapentin; meloxicam; tamsulosin; kidney stones; lithotripsy; nephrolithiasis

Outcome Measures

Primary Outcomes (1)

• Postoperative day 0 Pain

  The magnitude of pain (0-10) that the patient experiences in the evening after their surgery concludes

  4-6 hours after conclusion of surgery

Secondary Outcomes (3)

• Time to pain resolution

  Approximately the first 72-96 hours

• Opioid Consumption

  14 days following surgery

• Time to complete pain resolution

  14 days

Study Arms (2)

Multimodel Drug Regimen

EXPERIMENTAL

The patients randomized to this arm will receive the following multimodal oral drug regimen administered shortly before induction of general anesthesia 1. Tylenol, 975mg (3 tabs) 2. 800mg Gabapentin 3. 400mg Celecoxib 4. 10mg Oxycodone

Drug: Multimodal Oral Drug Regimen

Acetaminophen Only

ACTIVE COMPARATOR

The patients randomized to this arm will receive oral acetaminophen only administered shortly before induction of general anesthesia 1\. Tylenol, 975mg (3 tabs)

Drug: Acetaminophen

Interventions

Multimodal Oral Drug Regimen DRUG

Regimen of 4 pharmacologic agents that provides analgesia by acting on 4 different physiologic pain pathways

Also known as: Gabapentin 800mg, Oxycodone 10mg, Acetaminophen 975mg, Celecoxib 400mg

Multimodel Drug Regimen

Acetaminophen DRUG

Acetaminophen 975mg

Also known as: Tylenol

Acetaminophen Only

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patient (greater than 18 years old)
• Possesses or has access to cell phone with text message capability
• Undergoing ureteroscopy with lithotripsy for a ureteral or kidney stones

You may not qualify if:

• Does not possess or have access to a cell phone with text message capability
• Non-English speaking
• Incarcerated individuals
• undergoing planned secondary procedure
• pregnancy
• intellectual disability
• History of, anaphylactic, rash, or other hypersensitivity reaction to any of the study agents
• Patients with history of CABG, myocardial infarction, endovascular cardiac stent, gastrointestinal bleed, or gastric ulcer disease will not receive Celecoxib. They may still participate in the study otherwise, it will be documented that they did not receive an NSAID component.

Sponsors & Collaborators

• Kevin J Flynn MD: lead

Related Publications (6)

• Ahn ST, Kim JH, Park JY, Moon du G, Bae JH. Acute postoperative pain after ureteroscopic removal of stone: incidence and risk factors. Korean J Urol. 2012 Jan;53(1):34-9. doi: 10.4111/kju.2012.53.1.34. Epub 2012 Jan 25.

  PMID: 22323972 BACKGROUND

• Penprase B, Brunetto E, Dahmani E, Forthoffer JJ, Kapoor S. The efficacy of preemptive analgesia for postoperative pain control: a systematic review of the literature. AORN J. 2015 Jan;101(1):94-105.e8. doi: 10.1016/j.aorn.2014.01.030.

  PMID: 25537330 BACKGROUND

• Scales CD Jr, Smith AC, Hanley JM, Saigal CS; Urologic Diseases in America Project. Prevalence of kidney stones in the United States. Eur Urol. 2012 Jul;62(1):160-5. doi: 10.1016/j.eururo.2012.03.052. Epub 2012 Mar 31.

  PMID: 22498635 BACKGROUND

• Oberlin DT, Flum AS, Bachrach L, Matulewicz RS, Flury SC. Contemporary surgical trends in the management of upper tract calculi. J Urol. 2015 Mar;193(3):880-4. doi: 10.1016/j.juro.2014.09.006. Epub 2014 Sep 16.

  PMID: 25219700 BACKGROUND

• Barnes KT, Bing MT, Tracy CR. Do ureteric stent extraction strings affect stent-related quality of life or complications after ureteroscopy for urolithiasis: a prospective randomised control trial. BJU Int. 2014 Apr;113(4):605-9. doi: 10.1111/bju.12541.

  PMID: 24765679 BACKGROUND

• Hirschtritt ME, Delucchi KL, Olfson M. Outpatient, combined use of opioid and benzodiazepine medications in the United States, 1993-2014. Prev Med Rep. 2017 Dec 21;9:49-54. doi: 10.1016/j.pmedr.2017.12.010. eCollection 2018 Mar.

  PMID: 29340270 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi; Pain, Postoperative; Nephrolithiasis

Interventions

Gabapentin; Oxycodone; Acetaminophen; Celecoxib

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Aniline Compounds; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Chad Tracy, MD

  University of Iowa Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will not be made aware which treatment regimen they are receiving and neither will the attending urologist.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Urology Resident

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 8, 2018
• Study Start: August 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share