ThoracotomyPhase 3NCT05172570
Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
A Phase 3 study testing Gabapentin in people with Thoracotomy and Pain, Postoperative, run by Indiana University at 1 site in United States.
Trial summary
Gabapentin is a nerve medication that treats pain. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thoracotomy, Pain, Postoperative
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2021to 2 Mar 2022
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pt undergoing open thoracotomy at Indiana University Hospital
- ASA 1,2,3 or 4
- Age 18 or older, male or female
Who cannot join
- History of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs
- Patient on home dose of gabapentin or pregabalin
- Patient staying intubated after surgery
- Patient above 70yo
- Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
- Known allergy or other contraindications to the study medications, which include gabapentin
Show all 9Show fewer
- Patient unable to receive post-op epidural
- BMI above 40
- Creatinine clearance less than 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
Gabapentin is a nerve medication that treats pain. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. Our hypothesis is that higher doses of gabapentin will correlate with decreased pain at the incision and chest tube sites and decreased opioid consumption.
Read the detailed description
The purpose of this study is to determine the effectiveness of various dosages of gabapentin, as part of an ERAS protocol, for postoperative analgesic control after open thoracotomy and additionally determine if there is a correlation of the dosage of gabapentin with pulmonary complication and impaired cognition postoperatively.
Given the widespread use of gabapentin and the huge variability in dosing, our study aims to simplify ERAS protocols for thoracotomy by figuring out the optimal dosing of gabapentin and whether its use overall decreases postoperative opioid consumption and complications.
The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night.
- Conditions
- Thoracotomy, Pain, Postoperative
- Being tested
- Gabapentin
- Keywords
- acute pain, neuropathic pain
- Medical subject headings
- Pain, Postoperative, Acute Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called neurontin
Gabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain.
| Study group | Role | What they receive |
|---|---|---|
| No Gabapentin | No intervention | Patients will not receive any gabapentin postoperatively after open thoracotomy |
| 300 mg Gabapentin 3X per day | Active comparator | Patients will receive 300mg gabapentin 3x a day after open thoracotomy Receives: Drug: Gabapentin |
| 300 mg Gabapentin once per day at night | Active comparator | Patients will receive 300mg gabapentin once a day at night after open thoracotomy Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Measured: 1 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Measured: 24 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Measured: 48 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Measured: 72 hour after surgery
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
Measured: 96 hour after surgery
Secondary outcomes (26)
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Measured: 1 hour after surgery.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Measured: 24 hour after surgery.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Measured: 48 hour after surgery.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff administering the medications.
Measured: 72 hour after surgery.
Opioid Usage
opioid usage will be collected from electronically medical record as documented by nursing staff admisterning the medications.
Measured: 96 hour after surgery.
Time to First Opioid Request
the timeframe between end of surgery to first opioid request
Measured: As it first occurs, up to 96 hours after surgery
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Measured: 1hour after surgery.
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Measured: 24 hour after surgery.
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Measured: 48 hour after surgery.
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Measured: 72 hour after surgery.
Sedation Scores
Sedation is measured as minimum to maximum awareness; high value worse to less awareness (awake/alert, quietly awake, asleep but arousable, deep sleep)
Measured: 96 hour after surgery.
Incidence of Falls
Participants with one or more falls
Measured: As they occur up to 96 hours after surgery.
Pulmonary Complications
any incidence of increase oxygen requirements or respiratory depression will be recorded
Measured: As they occur up to 96 hours after surgery.
Hospital Length of Stay
timeframe from start of surgery to time of discharge (up to 24 days)
Measured: From the date of surgery to date of hospital discharge (up to 24 days)
Delirium
Number of Participants reported they experienced delirium.
Measured: 24 hours after surgery.
Delirium
incidence of delirium will be recorded
Measured: 48 hours after surgery.
Delirium
Number of Participants reported they experienced delirium.
Measured: 72 hours after surgery.
Delirium
Number of Participants reported they experienced delirium.
Measured: 96 hours after surgery.
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Measured: 24 hours after surgery.
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Measured: 48 hours after surgery.
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Measured: 72 hours after surgery.
Visual Disturbance
incidence of any visual disturbance reported by the participants will be reported.
Measured: 96 hours after surgery.
Dizziness
incidence of any dizziness reported by the participant reported.
Measured: 24 hours after surgery.
Dizziness
iincidence of any dizziness reported by the participant reported.
Measured: 48 hours after surgery.
Dizziness
incidence of any dizziness reported by the participant reported.
Measured: 72 hours after surgery.
Dizziness
incidence of any dizziness reported by the participant reported.
Measured: 96 hours after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start6 Apr 2021
- Primary completion25 Feb 2022
- Study completion2 Mar 2022
Why it stopped: Study terminated to to shortage if study supplies for epidurals and most enrolled has study deviations due to not receiving correct post study drug assignments.
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 (14)Papers the sponsor has linked to this study.
- Other trials for ThoracotomyStudies of the same condition, open and under way.
- More trials run by Indiana 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yar Yeap, Indiana University
- Investigators
- Yar Yeap, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05172570
- Sponsor's protocol ID
- 10069
- Status last verified
- Mar 2024
- First submitted
- 21 Apr 2021
- Last updated
- 21 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PubMed 28097305Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, McMurry TL, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of care: impact of an enhanced recovery protocol on length of stay, complications, and direct costs after colorectal surgery. J Am Coll Surg. 2015 Apr;220(4):430-43. doi: 10.1016/j.jamcollsurg.2014.12.042. Epub 2015 Jan 9.
PubMed 25797725Modesitt SC, Sarosiek BM, Trowbridge ER, Redick DL, Shah PM, Thiele RH, Tiouririne M, Hedrick TL. Enhanced Recovery Implementation in Major Gynecologic Surgeries: Effect of Care Standardization. Obstet Gynecol. 2016 Sep;128(3):457-66. doi: 10.1097/AOG.0000000000001555.
PubMed 27500337Martin LW, Sarosiek BM, Harrison MA, Hedrick T, Isbell JM, Krupnick AS, Lau CL, Mehaffey JH, Thiele RH, Walters DM, Blank RS. Implementing a Thoracic Enhanced Recovery Program: Lessons Learned in the First Year. Ann Thorac Surg. 2018 Jun;105(6):1597-1604. doi: 10.1016/j.athoracsur.2018.01.080. Epub 2018 Mar 3.
PubMed 29510097Brunelli A, Thomas C, Dinesh P, Lumb A. Enhanced recovery pathway versus standard care in patients undergoing video-assisted thoracoscopic lobectomy. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2084-2090. doi: 10.1016/j.jtcvs.2017.06.037. Epub 2017 Jun 22.
PubMed 28728783Ohnuma T, Raghunathan K, Moore S, Setoguchi S, Ellis AR, Fuller M, Whittle J, Pyati S, Bryan WE, Pepin MJ, Bartz RR, Haines KL, Krishnamoorthy V. Dose-Dependent Association of Gabapentinoids with Pulmonary Complications After Total Hip and Knee Arthroplasties. J Bone Joint Surg Am. 2020 Feb 5;102(3):221-229. doi: 10.2106/JBJS.19.00889.
PubMed 31804238Myhre M, Jacobsen HB, Andersson S, Stubhaug A. Cognitive Effects of Perioperative Pregabalin: Secondary Exploratory Analysis of a Randomized Placebo-controlled Study. Anesthesiology. 2019 Jan;130(1):63-71. doi: 10.1097/ALN.0000000000002473.
PubMed 30335626Rogers LJ, Bleetman D, Messenger DE, Joshi NA, Wood L, Rasburn NJ, Batchelor TJP. The impact of enhanced recovery after surgery (ERAS) protocol compliance on morbidity from resection for primary lung cancer. J Thorac Cardiovasc Surg. 2018 Apr;155(4):1843-1852. doi: 10.1016/j.jtcvs.2017.10.151. Epub 2017 Dec 19.
PubMed 29352586Van Haren RM, Mehran RJ, Mena GE, Correa AM, Antonoff MB, Baker CM, Woodard TC, Hofstetter WL, Roth JA, Sepesi B, Swisher SG, Vaporciyan AA, Walsh GL, Rice DC. Enhanced Recovery Decreases Pulmonary and Cardiac Complications After Thoracotomy for Lung Cancer. Ann Thorac Surg. 2018 Jul;106(1):272-279. doi: 10.1016/j.athoracsur.2018.01.088. Epub 2018 Mar 9.
PubMed 29530770Lunn TH, Husted H, Laursen MB, Hansen LT, Kehlet H. Analgesic and sedative effects of perioperative gabapentin in total knee arthroplasty: a randomized, double-blind, placebo-controlled dose-finding study. Pain. 2015 Dec;156(12):2438-2448. doi: 10.1097/j.pain.0000000000000309.
PubMed 26230741Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915.
PubMed 29238824Grosen K, Drewes AM, Hojsgaard A, Pfeiffer-Jensen M, Hjortdal VE, Pilegaard HK. Perioperative gabapentin for the prevention of persistent pain after thoracotomy: a randomized controlled trial. Eur J Cardiothorac Surg. 2014 Jul;46(1):76-85. doi: 10.1093/ejcts/ezu032. Epub 2014 Feb 26.
PubMed 24574444Kinney MA, Mantilla CB, Carns PE, Passe MA, Brown MJ, Hooten WM, Curry TB, Long TR, Wass CT, Wilson PR, Weingarten TN, Huntoon MA, Rho RH, Mauck WD, Pulido JN, Allen MS, Cassivi SD, Deschamps C, Nichols FC, Shen KR, Wigle DA, Hoehn SL, Alexander SL, Hanson AC, Schroeder DR. Preoperative gabapentin for acute post-thoracotomy analgesia: a randomized, double-blinded, active placebo-controlled study. Pain Pract. 2012 Mar;12(3):175-83. doi: 10.1111/j.1533-2500.2011.00480.x. Epub 2011 Jun 16.
PubMed 21676165Savelloni J, Gunter H, Lee KC, Hsu C, Yi C, Edmonds KP, Furnish T, Atayee RS. Risk of respiratory depression with opioids and concomitant gabapentinoids. J Pain Res. 2017 Nov 10;10:2635-2641. doi: 10.2147/JPR.S144963. eCollection 2017.
PubMed 29180889
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study Comparing Variable Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy
- ClinicalTrials.gov ID
- NCT05172570
- Acronym / sponsor ID
- 10069
- Conditions
- Thoracotomy, Pain, Postoperative
- Keywords
- acute pain, neuropathic pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated to to shortage if study supplies for epidurals and most enrolled has study deviations due to not receiving correct post study drug assignments.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 6 Apr 2021 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 2 Mar 2022 (actual)
- First posted
- 29 Dec 2021 (actual)
- Results
- Posted 21 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gabapentin is a nerve medication that treats pain. The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night. Our hypothesis is that higher doses of gabapentin will correlate with decreased pain at the incision and chest tube sites and decreased opioid consumption.
Detailed description
The purpose of this study is to determine the effectiveness of various dosages of gabapentin, as part of an ERAS protocol, for postoperative analgesic control after open thoracotomy and additionally determine if there is a correlation of the dosage of gabapentin with pulmonary complication and impaired cognition postoperatively.
Given the widespread use of gabapentin and the huge variability in dosing, our study aims to simplify ERAS protocols for thoracotomy by figuring out the optimal dosing of gabapentin and whether its use overall decreases postoperative opioid consumption and complications.
The specific aim of the study is to compare the difference in the postoperative use of no gabapentin, 300 mg gabapentin 3x daily, or 300 mg gabapentin once at night.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Gabapentin | No intervention | –Patients will not receive any gabapentin postoperatively after open thoracotomy |
| 300 mg Gabapentin 3X per day | Active comparator | Drug: GabapentinPatients will receive 300mg gabapentin 3x a day after open thoracotomy |
| 300 mg Gabapentin once per day at night | Active comparator | Drug: GabapentinPatients will receive 300mg gabapentin once a day at night after open thoracotomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pt undergoing open thoracotomy at Indiana University Hospital
- ASA 1,2,3 or 4
- Age 18 or older, male or female
Key exclusion criteria (9 listed)
- History of substance abuse in the past 6 months which would include heroin, marijuana or any other illegal street drugs
- Patient on home dose of gabapentin or pregabalin
- Patient staying intubated after surgery
- Patient above 70yo
- Patient (home dose) taking more than 30mg PO morphine equivalent (PME) per day
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 |
|---|---|---|
| GabapentinAlso: neurontinGabapentin is a common medication used preoperatively and postoperatively as part of multimodal analgesia to help with acute pain. | Drug | 300 mg Gabapentin 3X per day, 300 mg Gabapentin once per day at night |
Primary outcome
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time frame: 1 hour after surgery
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time frame: 24 hour after surgery
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time frame: 48 hour after surgery
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time frame: 72 hour after surgery
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores.
Time frame: 96 hour after surgery
The pain scores will be collected at incision and chest tube. It will be measured by the study team investigator using a Visual Analog Scale (VAS) using a scale of documentation 0-10 for 10 being the worst pain and 0 being no pain.
26 secondary outcomes
Opioid Usage
Time frame: 1 hour after surgery.
Opioid Usage
Time frame: 24 hour after surgery.
Opioid Usage
Time frame: 48 hour after surgery.
Opioid Usage
Time frame: 72 hour after surgery.
Opioid Usage
Time frame: 96 hour after surgery.
Time to First Opioid Request
Time frame: As it first occurs, up to 96 hours after surgery
Sedation Scores
Time frame: 1hour after surgery.
Sedation Scores
Time frame: 24 hour after surgery.
Sedation Scores
Time frame: 48 hour after surgery.
Sedation Scores
Time frame: 72 hour after surgery.
Sedation Scores
Time frame: 96 hour after surgery.
Incidence of Falls
Time frame: As they occur up to 96 hours after surgery.
Pulmonary Complications
Time frame: As they occur up to 96 hours after surgery.
Hospital Length of Stay
Time frame: From the date of surgery to date of hospital discharge (up to 24 days)
Delirium
Time frame: 24 hours after surgery.
Delirium
Time frame: 48 hours after surgery.
Delirium
Time frame: 72 hours after surgery.
Delirium
Time frame: 96 hours after surgery.
Visual Disturbance
Time frame: 24 hours after surgery.
Visual Disturbance
Time frame: 48 hours after surgery.
Visual Disturbance
Time frame: 72 hours after surgery.
Visual Disturbance
Time frame: 96 hours after surgery.
Dizziness
Time frame: 24 hours after surgery.
Dizziness
Time frame: 48 hours after surgery.
Dizziness
Time frame: 72 hours after surgery.
Dizziness
Time frame: 96 hours after surgery.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28097305Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Background: PubMed 25797725Thiele RH, Rea KM, Turrentine FE, Friel CM, Hassinger TE, McMurry TL, Goudreau BJ, Umapathi BA, Kron IL, Sawyer RG, Hedrick TL. Standardization of care: impact of an enhanced recovery protocol on length of stay, complications, and direct costs after colorectal surgery. J Am Coll Surg. 2015 Apr;220(4):430-43. doi: 10.1016/j.jamcollsurg.2014.12.042. Epub 2015 Jan 9.
- Background: PubMed 27500337Modesitt SC, Sarosiek BM, Trowbridge ER, Redick DL, Shah PM, Thiele RH, Tiouririne M, Hedrick TL. Enhanced Recovery Implementation in Major Gynecologic Surgeries: Effect of Care Standardization. Obstet Gynecol. 2016 Sep;128(3):457-66. doi: 10.1097/AOG.0000000000001555.
- Background: PubMed 29510097Martin LW, Sarosiek BM, Harrison MA, Hedrick T, Isbell JM, Krupnick AS, Lau CL, Mehaffey JH, Thiele RH, Walters DM, Blank RS. Implementing a Thoracic Enhanced Recovery Program: Lessons Learned in the First Year. Ann Thorac Surg. 2018 Jun;105(6):1597-1604. doi: 10.1016/j.athoracsur.2018.01.080. Epub 2018 Mar 3.
- Background: PubMed 28728783Brunelli A, Thomas C, Dinesh P, Lumb A. Enhanced recovery pathway versus standard care in patients undergoing video-assisted thoracoscopic lobectomy. J Thorac Cardiovasc Surg. 2017 Dec;154(6):2084-2090. doi: 10.1016/j.jtcvs.2017.06.037. Epub 2017 Jun 22.
- Background: PubMed 31804238Ohnuma T, Raghunathan K, Moore S, Setoguchi S, Ellis AR, Fuller M, Whittle J, Pyati S, Bryan WE, Pepin MJ, Bartz RR, Haines KL, Krishnamoorthy V. Dose-Dependent Association of Gabapentinoids with Pulmonary Complications After Total Hip and Knee Arthroplasties. J Bone Joint Surg Am. 2020 Feb 5;102(3):221-229. doi: 10.2106/JBJS.19.00889.
- Background: PubMed 30335626Myhre M, Jacobsen HB, Andersson S, Stubhaug A. Cognitive Effects of Perioperative Pregabalin: Secondary Exploratory Analysis of a Randomized Placebo-controlled Study. Anesthesiology. 2019 Jan;130(1):63-71. doi: 10.1097/ALN.0000000000002473.
- Background: PubMed 29352586Rogers LJ, Bleetman D, Messenger DE, Joshi NA, Wood L, Rasburn NJ, Batchelor TJP. The impact of enhanced recovery after surgery (ERAS) protocol compliance on morbidity from resection for primary lung cancer. J Thorac Cardiovasc Surg. 2018 Apr;155(4):1843-1852. doi: 10.1016/j.jtcvs.2017.10.151. Epub 2017 Dec 19.
- Background: PubMed 29530770Van Haren RM, Mehran RJ, Mena GE, Correa AM, Antonoff MB, Baker CM, Woodard TC, Hofstetter WL, Roth JA, Sepesi B, Swisher SG, Vaporciyan AA, Walsh GL, Rice DC. Enhanced Recovery Decreases Pulmonary and Cardiac Complications After Thoracotomy for Lung Cancer. Ann Thorac Surg. 2018 Jul;106(1):272-279. doi: 10.1016/j.athoracsur.2018.01.088. Epub 2018 Mar 9.
- Background: PubMed 26230741Lunn TH, Husted H, Laursen MB, Hansen LT, Kehlet H. Analgesic and sedative effects of perioperative gabapentin in total knee arthroplasty: a randomized, double-blind, placebo-controlled dose-finding study. Pain. 2015 Dec;156(12):2438-2448. doi: 10.1097/j.pain.0000000000000309.
- Background: PubMed 29238824Hah J, Mackey SC, Schmidt P, McCue R, Humphreys K, Trafton J, Efron B, Clay D, Sharifzadeh Y, Ruchelli G, Goodman S, Huddleston J, Maloney WJ, Dirbas FM, Shrager J, Costouros JG, Curtin C, Carroll I. Effect of Perioperative Gabapentin on Postoperative Pain Resolution and Opioid Cessation in a Mixed Surgical Cohort: A Randomized Clinical Trial. JAMA Surg. 2018 Apr 1;153(4):303-311. doi: 10.1001/jamasurg.2017.4915.
- Background: PubMed 24574444Grosen K, Drewes AM, Hojsgaard A, Pfeiffer-Jensen M, Hjortdal VE, Pilegaard HK. Perioperative gabapentin for the prevention of persistent pain after thoracotomy: a randomized controlled trial. Eur J Cardiothorac Surg. 2014 Jul;46(1):76-85. doi: 10.1093/ejcts/ezu032. Epub 2014 Feb 26.
- 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.
Yar Yeap, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Thoracotomy and Pain, Postoperative, run by Indiana 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 3 inclusion and 9 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 Mar 2024. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mar 2024). 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?
The Primary Endpoint of This Study Will be Incision and Chest Tube Site Pain Scores. (time frame: 1 hour after surgery). The study lists 5 primary outcomes in all. 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 NCT05172570, which also lists 14 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 Mar 2024.