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One dose of either gabapentin or placebo will be given to patients prior to thoracotomy. Patients will also receive an epidural infusion, intravenous patient-controlled analgesia with fentanyl, oral acetaminophen and intravenous ketorolac as needed to achieve optimal analgesia. Pain ratings and supplemental medication use will be recorded for 48 hours and will also be assessed at 3 months postoperatively to determine whether the patients who received gabapentin had improved analgesia and/or required less supplemental medication than the placebo group.
The gabapentin dose utilized is 600 mg. The epidural infusion utilizes bupivacaine 0.075% with hydromorphone 10 mcg/cc infusing at 6 cc/hour. The settings for the fentanyl patient-controlled analgesia device start at 10 mcg every 10 minutes with a 200 mcg 4 hour maximum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gabapentin preoperatively | Experimental | Preoperative gabapentin 600 mg orally within 2 hours prior to surgery. |
|
| Active placebo | Placebo Comparator | Diphenhydramine 12.5 mg orally 2 hours preoperatively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gabapentin | Drug | gabapentin 600 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Score at Rest | Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine. | 48 hours |
| Average Pain Score With Coughing the First Morning Following Surgery | Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10. | First morning following surgery |
| Average Pain Score With Coughing on Second Morning After Surgery | Numeric rating scale pain score with coughing on second morning after surgery, range 0-10. | Second morning after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Consumption in First 24 Hours Postoperatively | 24 hours | |
| Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively | Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively. |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle A. Kinney, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21676165 | Derived | Kinney 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gabapentin Preoperatively | Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. |
| FG001 | Active Placebo | Diphenhydramine 12.5 mg p.o. 2 hours preoperatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gabapentin Preoperatively | Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. |
| BG001 | Active Placebo | Diphenhydramine 12.5 mg p.o. 2 hours preoperatively. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Average Pain Score at Rest | Pain scores every 4 hours for 48 hours postoperatively, utilizing the numeric rating scale with 0 being no pain and 10 the most severe pain you can imagine. | The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst). | Posted | Mean | Standard Deviation | Units on a scale | 48 hours |
|
48 hours following entrance into the recovery room.
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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 | Gabapentin Preoperatively | Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sedation | Nervous system disorders | Systematic Assessment | Sedation was graded by nursing staff every 4 hours using the Pain Management Sedation Scale (0=awake; 1=drowsy, dozes intermittently, easily arousable; 2=sedated, sleeps, but can be aroused; 3=difficult to arouse |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle A. O. Kinney | Mayo Clinic | 507-266-9877 | kinney.michelle@mayo.edu |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077206 | Gabapentin |
| D004155 | Diphenhydramine |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
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|
|
| Diphenhydramine | Drug | Diphenhydramine 12.5 mg orally within 2 hours preoperatively, epidural infusion of 0.075% bupivacaine with 10 mcg/ml of hydromorphone at 6 ml/hour, fentanyl intravenous patient controlled analgesia at 10 mcg every 10 minutes as needed with a 200 mcg 4 hour lockout, oral acetaminophen 650 mg orally every 6 hours as needed for pain, intravenous ketorolac 15 mg every 6 hours as needed for pain. |
|
|
| 3 months postoperatively |
| Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively | Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively | 48 hours postoperatively |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Diphenhydramine 12.5 mg p.o. 2 hours preoperatively. |
|
|
| Secondary | Opioid Consumption in First 24 Hours Postoperatively | The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001). | Posted | Mean | Standard Deviation | mg | 24 hours |
|
|
|
| Secondary | Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively | Patients were contacted at 3 months post-thoracotomy and asked if they had pain at the thoracotomy site. We observed the number of participants with the presence of pain at thoracotomy site at 3 months postoperatively. | The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Patients who rated their average pain 1 or greater were included. | Posted | Number | Participants | 3 months postoperatively |
|
|
|
| Primary | Average Pain Score With Coughing the First Morning Following Surgery | Patients were asked on the first morning following surgery how they rated their pain with coughing utilizing the Numeric Rating Scale for pain, with 0 being no pain and 10 being the worst pain imaginable. The range is 0-10. | The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy. Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst). | Posted | Mean | Standard Deviation | Units on a scale | First morning following surgery |
|
|
|
| Primary | Average Pain Score With Coughing on Second Morning After Surgery | Numeric rating scale pain score with coughing on second morning after surgery, range 0-10. | The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and having undergone a thoracotomy.Numeric Rating Scale (NRS) ranges from 0 (no pain) to 10 (worst). | Posted | Mean | Standard Deviation | Unites on a scale | Second morning after surgery |
|
|
|
| Secondary | Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively | Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively | The number of participants analyzed included those who had successfully completed the protocol, by having received the study medication preoperatively, having received a functioning epidural prior to discharge from the postanesthesia care unit, and had a thoracotomy. Opioid use in mg is based on morphine equivalents (Hanks GW, Br J Cancer 2001). | Posted | Mean | Standard Deviation | mg | 48 hours postoperatively |
|
|
|
| 0 |
| 57 |
| 4 |
| 57 |
| EG001 | Active Placebo | Diphenhydramine 12.5 mg p.o. 2 hours preoperatively. | 0 | 63 | 4 | 63 |
|
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| 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 |
| D005021 | Ethylamines |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |