Pain
Conditions
Keywords
Preoperative gabapentin, Acute pain, Post-thoracotomy pain, Epidural analgesia
Brief summary
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.
Detailed description
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.
Interventions
DRUGGabapentin
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.
DRUGDiphenhydramine
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.
Sponsors
Michelle Kinney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 45-75 years * Undergoing thoracotomy (lobectomy, segmentectomy, wedge resection)
Exclusion criteria
* Undergoing chest wall resection, gastroesophageal surgery * Enrolled in another post-thoracotomy analgesic research protocol * Pre-existing pain syndrome * Current gabapentin or pregabalin therapy * Inability to understand the study protocol * Coagulopathy * Current use of anticoagulants * Allergy to medications on protocol * Creatinine \>1.3 * Moderate or severe aortic stenosis * Severe psychological disorders * Bacteremia, osteomyelitis, or infection at site of thoracic epidural placement * History of previous thoracotomy * Patient declines preoperative epidural catheter placement * Prisoners or other institutionalized individuals * Severe hepatic, renal or cardiovascular disorders * Women who can become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Pain Score at Rest | 48 hours | 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. |
| Average Pain Score With Coughing the First Morning Following Surgery | 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. |
| Average Pain Score With Coughing on Second Morning After Surgery | Second morning after surgery | Numeric rating scale pain score with coughing on second morning after surgery, range 0-10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Consumption in First 24 Hours Postoperatively | 24 hours | — |
| Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively | 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. |
| Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively | 48 hours postoperatively | Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin Preoperatively Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. | 72 |
| Active Placebo Diphenhydramine 12.5 mg p.o. 2 hours preoperatively. | 74 |
| Total | 146 |
Baseline characteristics
| Characteristic | Active Placebo | Gabapentin Preoperatively | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 36 Participants | 39 Participants | 75 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants | 33 Participants | 71 Participants |
| Age, Continuous | 64 years STANDARD_DEVIATION 7 | 64 years STANDARD_DEVIATION 7 | 64 years STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 74 participants | 72 participants | 146 participants |
| Sex: Female, Male Female | 38 Participants | 32 Participants | 70 Participants |
| Sex: Female, Male Male | 36 Participants | 40 Participants | 76 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 57 | 4 / 63 |
| serious Total, serious adverse events | 0 / 57 | 0 / 63 |
Outcome results
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.
Time frame: 48 hours
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Preoperatively | Average Pain Score at Rest | 3.1 Units on a scale | Standard Deviation 1.9 |
| Active Placebo | Average Pain Score at Rest | 2.9 Units on a scale | Standard Deviation 1.8 |
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.
Time frame: Second morning after surgery
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Preoperatively | Average Pain Score With Coughing on Second Morning After Surgery | 5.0 Unites on a scale | Standard Deviation 2.2 |
| Active Placebo | Average Pain Score With Coughing on Second Morning After Surgery | 5.1 Unites on a scale | Standard Deviation 2.5 |
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.
Time frame: First morning following surgery
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Preoperatively | Average Pain Score With Coughing the First Morning Following Surgery | 5.2 Units on a scale | Standard Deviation 2.9 |
| Active Placebo | Average Pain Score With Coughing the First Morning Following Surgery | 5.0 Units on a scale | Standard Deviation 2.6 |
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.
Time frame: 3 months postoperatively
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gabapentin Preoperatively | Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively | 37 Participants |
| Active Placebo | Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively | 38 Participants |
Secondary
Opioid Consumption in First 24 Hours Postoperatively
Time frame: 24 hours
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Preoperatively | Opioid Consumption in First 24 Hours Postoperatively | 111.9 mg | Standard Deviation 116.9 |
| Active Placebo | Opioid Consumption in First 24 Hours Postoperatively | 118.1 mg | Standard Deviation 94.7 |
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
Time frame: 48 hours postoperatively
Population: 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).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin Preoperatively | Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively | 114.4 mg | Standard Deviation 106.8 |
| Active Placebo | Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively | 121.6 mg | Standard Deviation 110.3 |