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Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion

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ClinicalTrials.gov Identifier: NCT03151746
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Luminita M. Tureanu, Northwestern University

Brief Summary:

The study's objective is to determine the efficacy of preoperative gabapentin in relieving postoperative pain, reducing opioid use and improving quality of recovery in subjects undergoing urologic surgery.

Investigators hypothesize that subjects receiving gabapentin will have lower pain scores, less opioid consumption and better quality of recovery as compared to subjects who are given a placebo.


Condition or disease Intervention/treatment Phase
Anesthesia Urethral Obstruction Drug: Placebo Drug: Gabapentin Phase 4

Detailed Description:

Approximately one hour prior to induction of anesthesia in preoperative holding area all enrolled subjects will receive PO Acetaminophen 650 mg, the Gabapentin group will receive PO Gabapentin 1200 mg, while the Control group will receive PO Placebo, with a small amount of water.

Upon arrival in the operating room, standard ASA monitors will be applied. Intraoperative, patients will receive a standardized anesthetic care. This care consists of induction with IV propofol 2mg/kg, IV fentanyl 2 mcg/kg (adjusted body weight), and IV rocuronium 0.6 mg/kg for tracheal intubation or IV succinylcholine 1mg/kg if rapid sequence induction is needed.

For maintenance of general anesthesia, investigators will use Sevoflurane, with the goal to maintain BP within 20% of preoperative baseline and BIS 40-60.

If HR > 100/min and BIS 40-60 may use IV esmolol 0.5 mg/kg. If BP and/or HR >20% preoperative baseline, and BIS 40- 60 despite above management, may titrate IV antihypertensive agents.

For PONV prophylaxis, 30 min before end of surgery investigatorswill administer IV ondansetron 8mg.

The time from end of surgery to extubation in OR will be documented with a free text note in the EMR.

After extubation all patients will be transported to PACU on 2-liter Oxygen by nasal cannula, which will be weaned off in the PACU.

The postoperative analgesics during Phase I of recovery in PACU will consist of IV Hydromorphone 0.2-0.4 mg prn pain to maintain adequate pain control (NPRS<4). During Phase II of recovery patients will receive PO Hydromorphone 2mg tablets every 4-6 hours as needed for pain (NPRS ≥ 4) and acetaminophen: 650mg PO every 6 hours

The following data will be collected every hour during phase I and phase II recovery:

  • pain (NPRS)
  • sedation (Ramsey sedation scale)
  • dizziness (1- mild, 2- moderate, 3- severe)
  • headache YES/No If yes: NPRS score HA
  • respiratory depression (hypoventilation/ apnea: RR < 10 bpm., desaturation: (SpO2 < 90%)
  • Sedated but still in pain (Yes/No)
  • PONV YES/NO
  • PONV receiving antiemetic treatment
  • time to first opioid administration (IV hydromorphone)
  • total amount of IV hydromorphone in PACU Phase I
  • total amount of oral analgesic (hydromorphone) in PACU Phase II
  • time to meet discharge criteria from PACU Phase I
  • time to meet discharge criteria from Phase II

Study research personnel will contact participants by phone or in the hospital at 24 hours and 48 hours postoperative and at approximately one week in the Urology clinic. The study research personnel will ask questions regarding pain (NPRS) and analgesic consumption. The IPSS and QOR-40 questionnaires will be administered and data will be recorded.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double Blind, Randomized, Placebo Controlled Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinded by using placebo or active drug supplied by Investigational Drug Pharmacy.
Primary Purpose: Prevention
Official Title: Effect of Preoperative Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion: a Double Blind, Randomized, Placebo Controlled Trial
Actual Study Start Date : January 14, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo pill administered 1 hour before planned surgical procedure
Drug: Placebo
Placebo pill administered orally 1 hour before planned surgical procedure

Experimental: Gabapentin
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Drug: Gabapentin
Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure




Primary Outcome Measures :
  1. 48 hours opioid consumption [ Time Frame: 48 hours ]
    Amount of opioid use in mg 48 hours after surgical procedure


Secondary Outcome Measures :
  1. 24 hours opioid consumption [ Time Frame: 24 hours ]
    Amount of opioid use in mg 24 hours opioid consumption

  2. 24 & 48 hour Pain Burden [ Time Frame: 24 and 48 hours ]
    Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = severe pain

  3. Study drug side effects [ Time Frame: 24 and 48 hours ]
    Gabapentin related side effects as identified at 24, 48 hours

  4. IPSS scores [ Time Frame: 24 hours, 48 hours and 1 week ]
    Evaluate urinary symptoms using the International Prostate Symptom Score (IPSS)

  5. QOR 40 scores [ Time Frame: 24 hours, 48 hours and 1 week ]
    Evaluate quality of recovery using the Quality of Recovery 40 (QoR 40) questionnaire a 40 question survey scored from 40 low to 200 high (good recovery)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years to 75 years
  • Patients with obstructive kidney stones undergoing elective ureteroscopy or cystoscopy with Ureteral stent placement

Exclusion Criteria:

  • Age less than 18 or more than 75 years
  • Acetaminophen allergy
  • Gabapentin allergy
  • Hydromorphone allergy
  • Chronic use of gabapentin
  • History of chronic pain (Pain for > than 3 months)
  • Chronic renal insufficiency (Creatinine > 1.3)
  • Seizure disorder
  • Psychiatric disorders (medically treated)
  • Chronic use of anticonvulsants, antidepressants, antipsychotics (use > 3 months)
  • Antacids ingested within 2 hours prior to surgery
  • History of gastric or duodenal ulcer
  • Pregnant or lactating
  • Inability to communicate in English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03151746


Contacts
Contact: Luminita Turneau, M.D. 312-695-0061 l-tureanu@northwestern.edu
Contact: Robert McCarthy, PharmD 312-695-4976 r-mccarthy@northwestern.edu

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Luminita Turneau, M.D.    312-695-0061    l-tureanu@northwestern.edu   
Contact: Robert McCarthy, PharmD    312-695-4976    r-mccarthy@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Luminita Turneau, M.D. Northwestern University

Publications:
Responsible Party: Luminita M. Tureanu, Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT03151746     History of Changes
Other Study ID Numbers: STU00205047
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Anticonvulsants
Pain, Postoperative
Urethral Obstruction
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Urethral Diseases
Urologic Diseases
Gabapentin
gamma-Aminobutyric Acid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents