Clinical trial NCT03151746: 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
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anesthesia
Urethral Obstruction
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double Blind, Randomized, Placebo Controlled Trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 48 Hours Morphine Equivalents Consumed.
timeFrame: Up to 48 hours after surgery
Secondary outcomes:
measure: 24 Hour Pain Burden
timeFrame: 24 hours after surgery
measure: QOR 40 Questionnaire Scores
timeFrame: 48 hours after surgical procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Luminita Tureanu, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.