Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00588159
Recruitment Status : Completed
First Posted : January 8, 2008
Results First Posted : August 12, 2011
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Michelle Kinney, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Gabapentin
Drug: Diphenhydramine
Enrollment 146
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gabapentin Preoperatively Active Placebo
Hide Arm/Group Description Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Period Title: Overall Study
Started 72 74
Completed 57 63
Not Completed 15 11
Arm/Group Title Gabapentin Preoperatively Active Placebo Total
Hide Arm/Group Description Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. Diphenhydramine 12.5 mg p.o. 2 hours preoperatively. Total of all reporting groups
Overall Number of Baseline Participants 72 74 146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 146 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
33
  45.8%
38
  51.4%
71
  48.6%
>=65 years
39
  54.2%
36
  48.6%
75
  51.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 74 participants 146 participants
64  (7) 64  (7) 64  (7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 74 participants 146 participants
Female
32
  44.4%
38
  51.4%
70
  47.9%
Male
40
  55.6%
36
  48.6%
76
  52.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants 74 participants 146 participants
72 74 146
1.Primary Outcome
Title Average Pain Score at Rest
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Gabapentin Preoperatively Active Placebo
Hide Arm/Group Description:
Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Overall Number of Participants Analyzed 57 63
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.1  (1.9) 2.9  (1.8)
2.Primary Outcome
Title Average Pain Score With Coughing the First Morning Following Surgery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Gabapentin Preoperatively Active Placebo
Hide Arm/Group Description:
Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Overall Number of Participants Analyzed 57 63
Mean (Standard Deviation)
Unit of Measure: Units on a scale
5.2  (2.9) 5.0  (2.6)
3.Primary Outcome
Title Average Pain Score With Coughing on Second Morning After Surgery
Hide Description Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.
Time Frame Second morning after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Gabapentin Preoperatively Active Placebo
Hide Arm/Group Description:
Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Overall Number of Participants Analyzed 57 63
Mean (Standard Deviation)
Unit of Measure: Unites on a scale
5.0  (2.2) 5.1  (2.5)
4.Secondary Outcome
Title Opioid Consumption in First 24 Hours Postoperatively
Hide Description [Not Specified]
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Gabapentin Preoperatively Active Placebo
Hide Arm/Group Description:
Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Overall Number of Participants Analyzed 57 63
Mean (Standard Deviation)
Unit of Measure: mg
111.9  (116.9) 118.1  (94.7)
5.Secondary Outcome
Title Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Gabapentin Preoperatively Active Placebo
Hide Arm/Group Description:
Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Overall Number of Participants Analyzed 57 63
Measure Type: Number
Unit of Measure: Participants
37 38
6.Secondary Outcome
Title Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively
Hide Description Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively
Time Frame 48 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Gabapentin Preoperatively Active Placebo
Hide Arm/Group Description:
Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Overall Number of Participants Analyzed 57 63
Mean (Standard Deviation)
Unit of Measure: mg
114.4  (106.8) 121.6  (110.3)
Time Frame 48 hours following entrance into the recovery room.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gabapentin Preoperatively Active Placebo
Hide Arm/Group Description Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery. Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
All-Cause Mortality
Gabapentin Preoperatively Active Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gabapentin Preoperatively Active Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/57 (0.00%)      0/63 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gabapentin Preoperatively Active Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/57 (7.02%)      4/63 (6.35%)    
Nervous system disorders     
Sedation  [1]  4/57 (7.02%)  4 4/63 (6.35%)  4
Indicates events were collected by systematic assessment
[1]
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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michelle A. O. Kinney
Organization: Mayo Clinic
Phone: 507-266-9877
Responsible Party: Michelle Kinney, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00588159     History of Changes
Other Study ID Numbers: 05-004145
First Submitted: December 18, 2007
First Posted: January 8, 2008
Results First Submitted: December 28, 2010
Results First Posted: August 12, 2011
Last Update Posted: May 4, 2016