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Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion

Primary Purpose

Anesthesia, Urethral Obstruction

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Gabapentin
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anesthesia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Gabapentin

Arm Description

Placebo pill administered 1 hour before planned surgical procedure

Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure

Outcomes

Primary Outcome Measures

48 Hours Morphine Equivalents Consumed.
Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.

Secondary Outcome Measures

24 Hour Pain Burden
Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable
QOR 40 Questionnaire Scores
Evaluate quality of recovery using the Quality of Recovery 40 (QoR 40) questionnaire a 40 question survey scored from 40 ( poor recovery) to 200 high (good recovery) 48 hours after the surgical procedure.

Full Information

First Posted
April 19, 2017
Last Updated
July 18, 2022
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03151746
Brief Title
Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion
Official Title
Effect of Preoperative Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion: a Double Blind, Randomized, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Insufficient enrollment
Study Start Date
January 14, 2018 (Actual)
Primary Completion Date
December 2, 2021 (Actual)
Study Completion Date
December 2, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Urethral Obstruction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Double Blind, Randomized, Placebo Controlled Trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Blinded by using placebo or active drug supplied by Investigational Drug Pharmacy.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo pill administered 1 hour before planned surgical procedure
Arm Title
Gabapentin
Arm Type
Experimental
Arm Description
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill administered orally 1 hour before planned surgical procedure
Intervention Type
Drug
Intervention Name(s)
Gabapentin
Intervention Description
Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
Primary Outcome Measure Information:
Title
48 Hours Morphine Equivalents Consumed.
Description
Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.
Time Frame
Up to 48 hours after surgery
Secondary Outcome Measure Information:
Title
24 Hour Pain Burden
Description
Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable
Time Frame
24 hours after surgery
Title
QOR 40 Questionnaire Scores
Description
Evaluate quality of recovery using the Quality of Recovery 40 (QoR 40) questionnaire a 40 question survey scored from 40 ( poor recovery) to 200 high (good recovery) 48 hours after the surgical procedure.
Time Frame
48 hours after surgical procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luminita Tureanu, M.D.
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12576847
Citation
Joshi HB, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG, Barry MJ. Indwelling ureteral stents: evaluation of symptoms, quality of life and utility. J Urol. 2003 Mar;169(3):1065-9; discussion 1069. doi: 10.1097/01.ju.0000048980.33855.90.
Results Reference
background
PubMed Identifier
27125392
Citation
Koprowski C, Kim C, Modi PK, Elsamra SE. Ureteral Stent-Associated Pain: A Review. J Endourol. 2016 Jul;30(7):744-53. doi: 10.1089/end.2016.0129. Epub 2016 May 23.
Results Reference
background
PubMed Identifier
24051389
Citation
Schmidt PC, Ruchelli G, Mackey SC, Carroll IR. Perioperative gabapentinoids: choice of agent, dose, timing, and effects on chronic postsurgical pain. Anesthesiology. 2013 Nov;119(5):1215-21. doi: 10.1097/ALN.0b013e3182a9a896. No abstract available.
Results Reference
background
PubMed Identifier
3963344
Citation
Mason CJ. High frequency jet ventilation through a Robertshaw double lumen tube. Anaesthesia. 1986 Mar;41(3):330. doi: 10.1111/j.1365-2044.1986.tb12811.x. No abstract available.
Results Reference
background
PubMed Identifier
22309784
Citation
Bala I, Bharti N, Chaubey VK, Mandal AK. Efficacy of gabapentin for prevention of postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor. Urology. 2012 Apr;79(4):853-7. doi: 10.1016/j.urology.2011.11.050. Epub 2012 Feb 4.
Results Reference
background

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Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion

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