Trial Outcomes & Findings for Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae (NCT NCT03031340)

NCT ID: NCT03031340

Last Updated: 2019-08-20

Results Overview

The primary objective of this study is to evaluate the role of three doses of pregabalin on intra and postoperative (48hrs) opioid requirements in patients undergoing fusion of two or more vertebrae.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

3 participants

Primary outcome timeframe

48 hours

Results posted on

2019-08-20

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo placebo: placebo	Pregabalin Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
Overall Study STARTED	2	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=2 Participants placebo: placebo	Pregabalin n=1 Participants Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.	Total n=3 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	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Population: Data not collected therefore no analysis

The primary objective of this study is to evaluate the role of three doses of pregabalin on intra and postoperative (48hrs) opioid requirements in patients undergoing fusion of two or more vertebrae.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 hours, 24 hours, 48 hours

Population: Data not collected therefore no analysis

evaluate pain using the visual analog scale (VAS) pain score at two hrs post-op, the morning following surgery 24 hours and 48 hours post-op

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

Population: Data not collected therefore no analysis

Find the incidence of 48 hours post operative nausea and vomiting in the target population

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours

Population: Data not collected therefore no analysis

48 hours post operative headache, dizziness, sedation and blurred vision

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours prior to surgery

Population: Data not collected therefore no analysis

Measure the level of pre-operative anxiety using the visual analog scale (VAS)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours post surgery

Population: Data not collected therefore no analysis

To measure the level of overall anesthesia satisfaction among the two groups at discharge.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pregabalin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=2 participants at risk placebo: placebo	Pregabalin n=1 participants at risk Pregabalin: On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
General disorders Death	0.00% 0/2	100.0% 1/1 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr.Singh Nair

Montefiore Medical Center

Phone: 7189205932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place