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Trial record 61 of 424 for:    Pregabalin

Pregabalin for the Treatment of Pain After Posterior Spinal Fusions

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ClinicalTrials.gov Identifier: NCT01366196
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : June 21, 2017
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Lumbar Spinal Fusions
Interventions Drug: Pregabalin 150 mg
Drug: Placebo
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group (C) Pregabalin Group (P)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 43 43
Completed 43 43
Not Completed 0 0
Arm/Group Title Control Group (C) Pregabalin Group (P) Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 43 43 86
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 43 participants 43 participants 86 participants
56.186  (12.599) 57.511  (13.491) 56.849  (12.993)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 43 participants 43 participants 86 participants
Female
22
  51.2%
22
  51.2%
44
  51.2%
Male
21
  48.8%
21
  48.8%
42
  48.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 43 participants 43 participants 86 participants
43
 100.0%
43
 100.0%
86
 100.0%
1.Primary Outcome
Title Patient Controlled Analgesia (PCA) Hydromorphone Usage
Hide Description [Not Specified]
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group (C) Pregabalin Group (P)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: mL
44  (12) 39  (9)
2.Secondary Outcome
Title Oral Analgesic Supplementation Use
Hide Description Tabulate number of patients that used supplemental oral analgesics
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group (C) Pregabalin Group (P)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 43
Measure Type: Count of Participants
Unit of Measure: Participants
25
  58.1%
21
  48.8%
3.Other Pre-specified Outcome
Title Numerical Pain Rating Scale Score on Day of Surgery
Hide Description Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
Time Frame Day of Surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group (C) Pregabalin Group (P)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.8  (2.6) 2.9  (2.2)
4.Other Pre-specified Outcome
Title Numerical Pain Rating Scale Score on Postoperative Day 1 at Rest
Hide Description Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
Time Frame Postoperative Day 1 at rest
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group (C) Pregabalin Group (P)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.7  (2.1) 3.3  (2.4)
5.Other Pre-specified Outcome
Title Numerical Pain Rating Scale Score With Physical Therapy on Postoperative Day 1
Hide Description Pain scores based on a scale of 0 to 10 with 0 being no pain and 10 being the worst pain imaginable.
Time Frame Postoperative Day 1 with Physical Therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group (C) Pregabalin Group (P)
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 43 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.3  (3.0) 4.5  (3.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group (C) Pregabalin Group (P)
Hide Arm/Group Description

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.

Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.

All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.

On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.

Placebo: Patients will first receive two capsules of the placebo drug (with no active ingredients per dose) one hour before surgery. Patients will continue taking two capsules per day until POD 14.

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.

Postoperative pain will be assessed daily until discharge using a verbal Numerical Rating Scale (NRS) at rest and during physical therapy, by both physical therapists and blinded research assistants.

All narcotics (i.v. PCA, oral or IM/SQ rescue doses) will be tabulated during their hospital stay, and patients will be asked to document their oral narcotic use after discharge.

On the day of discharge, patients will be given a self report data sheet, in which they will be asked to record their daily pain level at rest, with movement, and whether their pain interfered with sleep.

Pregabalin 150 mg: Patients will receive two 75 mg capsules of pregabalin 1 hour before surgery. They continue to take 2 capsules of 75 mg (total 150 mg) until POD 14.

All-Cause Mortality
Control Group (C) Pregabalin Group (P)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Group (C) Pregabalin Group (P)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group (C) Pregabalin Group (P)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/43 (0.00%)   0/43 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael Urban
Organization: Hss
Phone: (212) 606-1000
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01366196     History of Changes
Other Study ID Numbers: IRB #27092
First Submitted: June 2, 2011
First Posted: June 3, 2011
Results First Submitted: March 23, 2017
Results First Posted: June 21, 2017
Last Update Posted: March 30, 2018