Trial Outcomes & Findings for Pregabalin for the Treatment of Pain After Posterior Spinal Fusions (NCT NCT01366196)

NCT ID: NCT01366196

Last Updated: 2022-04-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: Postoperative day 1
• Results posted on: 2022-04-14

Participant Flow

Participant milestones

Measure	Control Group (C) Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.	Pregabalin Group (P) Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
Overall Study STARTED	43	43
Overall Study COMPLETED	43	43
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

Baseline characteristics by cohort

Measure	Control Group (C) n=43 Participants Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.	Pregabalin Group (P) n=43 Participants Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.	Total n=86 Participants Total of all reporting groups
Age, Continuous	56.186 years STANDARD_DEVIATION 12.599 • n=5 Participants	57.511 years STANDARD_DEVIATION 13.491 • n=7 Participants	56.849 years STANDARD_DEVIATION 12.993 • n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	43 Participants n=5 Participants	43 Participants n=7 Participants	86 Participants n=5 Participants

PRIMARY outcome

Timeframe: Postoperative day 1

Outcome measures

Measure	Control Group (C) n=43 Participants Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.	Pregabalin Group (P) n=43 Participants Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
Patient Controlled Analgesia (PCA) Hydromorphone Usage	44 mL Standard Deviation 12	39 mL Standard Deviation 9

SECONDARY outcome

Timeframe: Day of surgery

Tabulate number of patients that used supplemental oral analgesics

Outcome measures

Measure	Control Group (C) n=43 Participants Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.	Pregabalin Group (P) n=43 Participants Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
Oral Analgesic Supplementation Use	25 Participants	21 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day of Surgery

Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.

Outcome measures

Measure	Control Group (C) n=43 Participants Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.	Pregabalin Group (P) n=43 Participants Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
Numerical Pain Rating Scale Score on Day of Surgery	3.8 units on a scale Standard Deviation 2.6	2.9 units on a scale Standard Deviation 2.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Postoperative Day 1 at rest

Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.

Outcome measures

Measure	Control Group (C) n=43 Participants Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.	Pregabalin Group (P) n=43 Participants Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest	3.7 units on a scale Standard Deviation 2.1	3.3 units on a scale Standard Deviation 2.4

OTHER_PRE_SPECIFIED outcome

Timeframe: Postoperative Day 1 with Physical Therapy

Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.

Outcome measures

Measure	Control Group (C) n=43 Participants Patients in the control group will receive a placebo tablet with a sip of water one hour prior to surgery and a placebo tablet twice a day for a total of two weeks.	Pregabalin Group (P) n=43 Participants Patients in the treatment group will receive 150 mg of pregabalin with a sip of water one hour prior to surgery, and then 150 mg daily (75 mg BID) for a total of two weeks.
Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1	4.3 units on a scale Standard Deviation 3.0	4.5 units on a scale Standard Deviation 3.4

Adverse Events

Control Group (C)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pregabalin Group (P)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Urban

Hss

Phone: (212) 606-1000

Email: UrbanM@hss.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place