AnesthesiaPhase 4NCT03151746
Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion
A Phase 4 study testing Gabapentin in people with Anesthesia and Urethral Obstruction, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Anesthesia, Urethral Obstruction
- What is being tested?
- Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2018to 2 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years to 75 years
- Patients with obstructive kidney stones undergoing elective ureteroscopy or cystoscopy with Ureteral stent placement
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Anesthesia, Urethral Obstruction
- Being tested
- Placebo, Gabapentin
- Medical subject headings
- Urethral Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo pill administered orally 1 hour before planned surgical procedure
GabapentinDrug
Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo pill administered 1 hour before planned surgical procedure Receives: Drug: Placebo |
| Gabapentin | Experimental | Gabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
48 Hours Morphine Equivalents Consumed.
Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.
Measured: Up to 48 hours after surgery
Secondary outcomes (2)
24 Hour Pain Burden
Pain scores using an 11 point numeric pain rating scale 0=no pain 10 = worst pain imaginable
Measured: 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.
Measured: 48 hours after surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start14 Jan 2018
- Primary completion2 Dec 2021
- Study completion2 Dec 2021
Why it stopped: Insufficient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double Blind, Randomized, Placebo Controlled Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luminita M. Tureanu, Northwestern University
- Investigators
- Luminita Tureanu, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03151746
- Sponsor's protocol ID
- STU00205047
- Status last verified
- Jul 2022
- First submitted
- 19 Apr 2017
- Last updated
- 21 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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 12576847Koprowski 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 27125392Schmidt 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 24051389Mason 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 3963344Bala 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 at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Gabapentin on Postoperative Pain Associated With Ureteroscopy and Stents Insertion: a Double Blind, Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03151746
- Acronym / sponsor ID
- STU00205047
- Conditions
- Anesthesia, Urethral Obstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 14 Jan 2018 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Posted 21 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double Blind, Randomized, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill administered 1 hour before planned surgical procedure |
| Gabapentin | Experimental | Drug: GabapentinGabapentin pill (1200mg) administered orally 1 hour prior to planned surgical procedure |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years to 75 years
- Patients with obstructive kidney stones undergoing elective ureteroscopy or cystoscopy with Ureteral stent placement
Key exclusion criteria (14 listed)
- Age less than 18 or more than 75 years
- Acetaminophen allergy
- Gabapentin allergy
- Hydromorphone allergy
- Chronic use of gabapentin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo pill administered orally 1 hour before planned surgical procedure | Drug | Placebo |
| GabapentinGabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure | Drug | Gabapentin |
Primary outcome
48 Hours Morphine Equivalents Consumed.
Time frame: Up to 48 hours after surgery
Total morphine equivalents in milligrams consumed during the first 48 hours after surgery.
2 secondary outcomes
24 Hour Pain Burden
Time frame: 24 hours after surgery
QOR 40 Questionnaire Scores
Time frame: 48 hours after surgical procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12576847Joshi 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.
- Background: PubMed 27125392Koprowski 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.
- Background: PubMed 24051389Schmidt 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.
- Background: PubMed 3963344Mason 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.
- Background: PubMed 22309784Bala 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luminita Tureanu, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Anesthesia and Urethral Obstruction, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
48 Hours Morphine Equivalents Consumed. (time frame: Up to 48 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03151746, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.