N/A
N=146
Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia
Pain
Bottom Line
View on ClinicalTrials.gov: NCT00588159 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Average Pain Score at Rest — 3.1; 2.9 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gabapentin (Drug); Diphenhydramine (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Michelle Kinney
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Score at Rest |
3.1; 2.9 | — |
| PRIMARY Average Pain Score With Coughing the First Morning Following Surgery |
5.2; 5.0 | — |
| PRIMARY Average Pain Score With Coughing on Second Morning After Surgery |
5.0; 5.1 | — |
| SECONDARY Opioid Consumption in First 24 Hours Postoperatively |
111.9; 118.1 | — |
| SECONDARY Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively |
37; 38 | — |
| SECONDARY Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively |
114.4; 121.6 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00588159). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.