Trial Outcomes & Findings for Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia (NCT NCT00588159)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

146 participants

Primary outcome timeframe

48 hours

Results posted on

2016-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	Gabapentin Preoperatively Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Overall Study STARTED	72	74
Overall Study COMPLETED	57	63
Overall Study NOT COMPLETED	15	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Gabapentin for Acute and Chronic Post-thoracotomy Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Gabapentin Preoperatively n=72 Participants Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo n=74 Participants Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.	Total n=146 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	38 Participants n=7 Participants	71 Participants n=5 Participants
Age, Categorical >=65 years	39 Participants n=5 Participants	36 Participants n=7 Participants	75 Participants n=5 Participants
Age, Continuous	64 years STANDARD_DEVIATION 7 • n=5 Participants	64 years STANDARD_DEVIATION 7 • n=7 Participants	64 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	38 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	36 Participants n=7 Participants	76 Participants n=5 Participants
Region of Enrollment United States	72 participants n=5 Participants	74 participants n=7 Participants	146 participants n=5 Participants

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Gabapentin Preoperatively n=57 Participants Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo n=63 Participants Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Average Pain Score at Rest	3.1 Units on a scale Standard Deviation 1.9	2.9 Units on a scale Standard Deviation 1.8

PRIMARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	Gabapentin Preoperatively n=57 Participants Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo n=63 Participants Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Average Pain Score With Coughing the First Morning Following Surgery	5.2 Units on a scale Standard Deviation 2.9	5.0 Units on a scale Standard Deviation 2.6

PRIMARY outcome

Timeframe: 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).

Numeric rating scale pain score with coughing on second morning after surgery, range 0-10.

Outcome measures

Outcome measures
Measure	Gabapentin Preoperatively n=57 Participants Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo n=63 Participants Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Average Pain Score With Coughing on Second Morning After Surgery	5.0 Unites on a scale Standard Deviation 2.2	5.1 Unites on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Gabapentin Preoperatively n=57 Participants Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo n=63 Participants Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Opioid Consumption in First 24 Hours Postoperatively	111.9 mg Standard Deviation 116.9	118.1 mg Standard Deviation 94.7

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Gabapentin Preoperatively n=57 Participants Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo n=63 Participants Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Number of Participants With Pain at Thoracotomy Site 3 Months Postoperatively	37 Participants	38 Participants

SECONDARY outcome

Timeframe: 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).

Opioid equivalents (parenteral and/or oral) utilized by patient between hours 24-48 postoperatively

Outcome measures

Outcome measures
Measure	Gabapentin Preoperatively n=57 Participants Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo n=63 Participants Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Opioid Consumption in Second 24 Hour Hour Period (Hours 24-48) Postoperatively	114.4 mg Standard Deviation 106.8	121.6 mg Standard Deviation 110.3

Adverse Events

Gabapentin Preoperatively

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Active Placebo

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Gabapentin Preoperatively n=57 participants at risk Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.	Active Placebo n=63 participants at risk Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
Nervous system disorders Sedation	7.0% 4/57 • Number of events 4 • 48 hours following entrance into the recovery room.	6.3% 4/63 • Number of events 4 • 48 hours following entrance into the recovery room.

Additional Information

Dr. Michelle A. O. Kinney

Mayo Clinic

Phone: 507-266-9877

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place