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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

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03151746
Enrollment
20
Registered
2017-05-12
Start date
2018-01-14
Completion date
2021-12-02
Last updated
2022-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Urethral Obstruction

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.

Interventions

DRUGPlacebo

Placebo pill administered orally 1 hour before planned surgical procedure

DRUGGabapentin

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

Sponsors

Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Blinded by using placebo or active drug supplied by Investigational Drug Pharmacy.

Intervention model description

Double Blind, Randomized, Placebo Controlled Trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
48 Hours Morphine Equivalents Consumed.Up to 48 hours after surgeryTotal morphine equivalents in milligrams consumed during the first 48 hours after surgery.

Secondary

MeasureTime frameDescription
24 Hour Pain Burden24 hours after surgeryPain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable
QOR 40 Questionnaire Scores48 hours after surgical procedureEvaluate 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Placebo
Placebo pill administered 1 hour before planned surgical procedure Placebo: Placebo pill administered orally 1 hour before planned surgical procedure
9
Gabapentin
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure Gabapentin: Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
11
Total20

Baseline characteristics

CharacteristicTotalGabapentinPlacebo
Age, Continuous49 years
STANDARD_DEVIATION 14.9
49 years
STANDARD_DEVIATION 14.72
49 years
STANDARD_DEVIATION 16.4
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants10 Participants7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Height (Inches)67.5 Inches
STANDARD_DEVIATION 3.89
67.7 Inches
STANDARD_DEVIATION 4.33
67.2 Inches
STANDARD_DEVIATION 3.27
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants1 Participants1 Participants
Race (NIH/OMB)
Black or African American
1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
17 Participants10 Participants7 Participants
Region of Enrollment
United States
20 participants11 participants9 participants
Sex: Female, Male
Female
6 Participants3 Participants3 Participants
Sex: Female, Male
Male
14 Participants8 Participants6 Participants
Weight (kilograms)83.4 Kilograms
STANDARD_DEVIATION 19.74
76.1 Kilograms
STANDARD_DEVIATION 17.48
89.58 Kilograms
STANDARD_DEVIATION 21.6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 90 / 11
other
Total, other adverse events
2 / 92 / 11
serious
Total, serious adverse events
0 / 90 / 11

Outcome results

Primary

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

ArmMeasureValue (MEAN)
Placebo48 Hours Morphine Equivalents Consumed.51.87 morphine milligrams
Gabapentin48 Hours Morphine Equivalents Consumed.15.71 morphine milligrams
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Placebo24 Hour Pain Burden4.11 score on a scaleStandard Deviation 2.26
Gabapentin24 Hour Pain Burden3.11 score on a scaleStandard Deviation 2.67
Secondary

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

Population: 3 in the placebo and 3 in the gabapentin group did not complete the survey at 48 hours post operative.

ArmMeasureValue (MEAN)
PlaceboQOR 40 Questionnaire Scores181.3 score on a scale
GabapentinQOR 40 Questionnaire Scores187.5 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026