Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion

Effect of Preoperative Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion: a Double Blind, Randomized, Placebo Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Anesthesia; Urethral Obstruction
• Intervention / Treatment: Drug: Placebo; Drug: Gabapentin

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
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
48 Hours Morphine Equivalents Consumed.	Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.	Up to 48 hours after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24 Hour Pain Burden	Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable	24 hours after surgery
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.	48 hours after surgical procedure

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Luminita Tureanu, M.D., Northwestern University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2018
• Primary Completion (Actual): December 2, 2021
• Study Completion (Actual): December 2, 2021

Study Registration Dates

• First Submitted: April 19, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Urethral Diseases; Pain, Postoperative; Urethral Obstruction; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Tranquilizing Agents; Psychotropic Drugs; Anti-Anxiety Agents; Anticonvulsants; Antimanic Agents; Gabapentin
• Other Study ID Numbers: STU00205047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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