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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo pill administered 1 hour before planned surgical procedure |
|
| Gabapentin | Experimental | Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo pill administered orally 1 hour before planned surgical procedure |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luminita Tureanu, M.D. | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12576847 | Background | 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. | |
| 27125392 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo pill administered 1 hour before planned surgical procedure Placebo: Placebo pill administered orally 1 hour before planned surgical procedure |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo pill administered 1 hour before planned surgical procedure Placebo: Placebo pill administered orally 1 hour before planned surgical procedure |
| BG001 | Gabapentin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 48 Hours Morphine Equivalents Consumed. | Total morphine equivalents in milligrams consumed during the first 48 hours after surgery. | Posted | Mean | Full Range | morphine milligrams | Up to 48 hours after surgery |
|
7 days after surgical procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo pill administered 1 hour before planned surgical procedure Placebo: Placebo pill administered orally 1 hour before planned surgical procedure |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
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 .
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Paul Fitzgerald | Northwestern University | 312-695-1064 | p-fitzgerald2@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | Jun 27, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| ID | Term |
|---|---|
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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Double Blind, Randomized, Placebo Controlled Trial
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Blinded by using placebo or active drug supplied by Investigational Drug Pharmacy.
| Gabapentin |
| Drug |
Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure |
|
| 48 hours after surgical procedure |
| 24051389 | Background | 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. |
| 3963344 | Background | 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. |
| 22309784 | Background | 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. |
Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure
Gabapentin: Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height (Inches) | Mean | Standard Deviation | Inches |
|
| Weight (kilograms) | Mean | Standard Deviation | Kilograms |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 24 Hour Pain Burden | Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable | Posted | Mean | Standard Deviation | score on a scale | 24 hours after surgery |
|
|
|
| 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. | 3 in the placebo and 3 in the gabapentin group did not complete the survey at 48 hours post operative. | Posted | Mean | Full Range | score on a scale | 48 hours after surgical procedure |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 2 |
| 9 |
| EG001 | 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 | 0 | 11 | 0 | 11 | 2 | 11 |
| Headache | Musculoskeletal and connective tissue disorders | SNOMED CT | Systematic Assessment | Headache |
|
| Dizziness | General disorders | SNOMED CT | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002087 |
| Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |