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

Kevin J Flynn MD

Status and phase: Withdrawn; Phase 4

Conditions: Pain, Postoperative; Kidney Calculi

Treatments: Drug: Acetaminophen; Drug: Multimodal Oral Drug Regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT03549611

201805826

Details and patient eligibility

About

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.

Full description

Adult patients undergoing ureteroscopy for kidney stones will be screened and those who meet initial study criteria (adult, English speaking, non-pregnant, non-intellectually disabled patients), will be sent an information letter outlining the study. Interested patients, who possess a phone capable of text messaging will be consented to enroll in the study and randomized to one of two preoperative analgesic treatment arms (see below) that will be administered in the preoperative area prior to induction of general anesthesia.

Multimodal Analgesia Arm

1. Acetaminophen 975mg
2. Gabapentin 800mg
3. Oxycodone 10mg
4. Celecoxib 400mg

Acetaminophen Only Analgesia Arm

a. Acetaminophen 975mg

Consenting patients will fill out a baseline demographics questionnaire as well as provide baseline levels of pain and opioid consumption prior to surgery. They will also be enrolled to receive automated postoperative pain assessments and opioid consumption inquiries via text message. The patients will be blinded to the treatment they are receiving. The research team will not be blinded. The patient will then proceed with their planned ureteroscopy. The patient will then undergo their planned ureteroscopy with lithotripsy for kidney stone disease; the study does not change any parameters about the surgery itself. The general anesthesia regimen will be standardized to one particular standard of care method so as to minimize the potential effect of confounders.

All patients (patients in both preoperative analgesia treatment regimen arms) will be monitored in the post-anesthesia recovery unit for pain, blood pressure, sedation level monitored by the Ramsey Sedation Scale. Once they have recovered appropriately and met standard discharge criteria they will be discharged with the following analgesic regimen

1. Tylenol 650 every 6 hours x 7 day
2. Oxybutynin 5mg three times daily as needed for x 7 days
3. Flomax 0.4mg daily x 7 days
4. Oxycodone, 5mg as needed 15 pills
5. Celecoxib daily for 7 days

Patients will receive a pain assessment via text message the evening of postoperative day 0, and then twice a day for 14 days. Patients will also receive an opioid consumption inquiry once a day for 14 days. On postoperative day 15 patients will be asked if they were happy with their postoperative pain control.

During the study period the research team will access the patients electronic medical record to review and record the following information

• Current medications
• height, weight, age, gender, marital status, city, state of residence
• Co-morbid medical conditions
• insurance
• stone parameters: size (mmm), location, laterality, number of stones,
• Operative factors: instruments used, operative time, operative complications
• post-operative course: emergency department visits, unexpected phone calls, unexpected clinic visits, other 30-day complications

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

Multimodel Drug Regimen

Experimental group

Description:

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

Treatment:

Drug: Multimodal Oral Drug Regimen

Acetaminophen Only

Active Comparator group

Description:

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

Treatment:

Drug: Acetaminophen