CClinicalTrials.gg
TerminatedNCT03151746Updated Jul 21, 2022Results posted

Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion

A Phase 4 interventional study of Placebo and Gabapentin in Anesthesia and Urethral Obstruction, sponsored by Northwestern University. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-07-21.

Sponsored by Northwestern University · Phase 4, Interventional, and Prevention

Why this study was terminated
Insufficient enrollment
Phase
Phase 4
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Anesthesia
  • Urethral Obstruction
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
20 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Placebo pill administered 1 hour before planned surgical procedure

    Drug: Placebo

  • Experimental
    Gabapentin

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

    Drug: Gabapentin

Interventions

  • DrugPlacebo

    Placebo pill administered orally 1 hour before planned surgical procedure

  • DrugGabapentin

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

05

What researchers measure

Primary outcomes

  1. 48 Hours Morphine Equivalents Consumed.

    Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.

    Time frame: Up to 48 hours after surgery

Secondary outcomes

  1. 24 Hour Pain Burden

    Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable

    Time frame: 24 hours after surgery

  2. 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.

    Time frame: 48 hours after surgical procedure

06

Results

Posted Jul 21, 2022
Limitations and caveats
The limitation to this study is that enrollment was affected by COVID 19 protocols within the hospital enrollment. This is why the project was terminated early .

Participant flow

Participant flow — Overall Study
MilestonePlaceboGabapentin
Started911
Completed911
Not completed00

Outcome measures

Primary48 Hours Morphine Equivalents Consumed.

Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.

Time frame:
Up to 48 hours after surgery
Reported as:
Mean · morphine milligrams
48 Hours Morphine Equivalents Consumed.
morphine milligramsPlaceboGabapentin
48 Hours Morphine Equivalents Consumed.51.87 (0 to 204)15.71 (0 to 48)
Secondary24 Hour Pain Burden

Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable

Time frame:
24 hours after surgery
Reported as:
Mean · score on a scale
24 Hour Pain Burden
score on a scalePlaceboGabapentin
24 Hour Pain Burden4.11 ± 2.263.11 ± 2.67
SecondaryQOR 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.

Time frame:
48 hours after surgical procedure
Reported as:
Mean · score on a scale
QOR 40 Questionnaire Scores
score on a scalePlaceboGabapentin
QOR 40 Questionnaire Scores181.3 (160 to 198)187.5 (171 to 200)

Adverse events

Collected over 7 days after surgical procedure.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/9 (0%)0/9 (0%)2/9 (22.2%)
Gabapentin0/11 (0%)0/11 (0%)2/11 (18.2%)
Most frequent other events
Most frequent other events
EventPlaceboGabapentin
NauseaGastrointestinal disorders1/92/11
HeadacheMusculoskeletal and connective tissue disorders0/92/11
DizzinessGeneral disorders1/92/11

Baseline characteristics

Age, Continuous
Age, Continuous(years)PlaceboGabapentinTotal
Mean49 ± 16.449 ± 14.7249 ± 14.9
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboGabapentinTotal
Female336
Male6814
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)PlaceboGabapentinTotal
Hispanic or Latino213
Not Hispanic or Latino71017
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboGabapentinTotal
American Indian or Alaska Native000
Asian112
Native Hawaiian or Other Pacific Islander000
Black or African American101
White71017
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)PlaceboGabapentinTotal
United States91120
Height (Inches)
Height (Inches)(Inches)PlaceboGabapentinTotal
Mean67.2 ± 3.2767.7 ± 4.3367.5 ± 3.89
Weight (kilograms)
Weight (kilograms)(Kilograms)PlaceboGabapentinTotal
Mean89.58 ± 21.676.1 ± 17.4883.4 ± 19.74
07

Study locations

1 site
  • Northwestern University
    Chicago, Illinois 60611, United States
08

References and documents

Publications

  • 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. PubMed 12576847 ↗
  • 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. PubMed 27125392 ↗
  • 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. PubMed 24051389 ↗
  • 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. PubMed 3963344 ↗
  • 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. PubMed 22309784 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 19, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03151746
Lead sponsor
Northwestern University
Responsible party
Luminita M. Tureanu (Principal Investigator, Northwestern University) — Principal investigator
First posted
May 12, 2017
Start date
Jan 14, 2018
Primary completion
Dec 2, 2021
Completion
Dec 2, 2021
Results posted
Jul 21, 2022
Last update
Jul 21, 2022

Study contacts

Luminita Tureanu, M.D.
principal investigator · Northwestern University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion