Trial Outcomes & Findings for Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica (NCT NCT01391858)

NCT ID: NCT01391858

Last Updated: 2014-08-12

Results Overview

IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 80 participants
• Primary outcome timeframe: Participants received PCA pump, an average of 24 hrs after mastectomy
• Results posted on: 2014-08-12

Participant Flow

In recent years, surgical techniques have evolved from mastectomy with lymph node dissections to other forms of less invasive or nonsurgical techniques and these changes reduced the number of patients getting an axillary lymph node dissection (personal communication with the study-associated surgeon).

A total of 80 patients were consented. 7 patients did not show up for surgery. Of the 73 patients randomized, only 49 received intervention. The remaining 24 either had their surgery cancelled, withdrew their consent before intervention, or did not receive the loading dose in time to continue with the study.

Participant milestones

Measure	Pregabalin Pregabalin 300 mg 1-2 hrs. before the surgery and then 150 mg twice a day for 14 days	Placebo Placebo 1-2 hrs. before the surgery and then twice daily for 14 days
Overall Study STARTED	25	24
Overall Study COMPLETED	23	24
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Postoperative Pain and Morphine Consumption After Mastectomy - Lyrica

Baseline characteristics by cohort

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo	Total n=47 Participants Total of all reporting groups
Age, Continuous	50 years STANDARD_DEVIATION 9 • n=5 Participants	47 years STANDARD_DEVIATION 8 • n=7 Participants	49 years STANDARD_DEVIATION 7 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants	24 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	23 participants n=5 Participants	24 participants n=7 Participants	47 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants received PCA pump, an average of 24 hrs after mastectomy

IV Patient Controlled Analgesia (PCA) morphine for rescue pain management in the immediate postoperative period for an average of 24 hrs after mastectomy

Outcome measures

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo
The Postoperative Opioid Requirement After Mastectomy	9 milligram (mg) Interval 2.0 to 29.0	7.5 milligram (mg) Interval 2.4 to 23.0

PRIMARY outcome

Timeframe: Participants were followed for the consumption of oral opioid for the duration of hospital stay, an average of 3 days after mastectomy

Oral opioids consumption after mastectomy until hospital discharge.

Outcome measures

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo
Oral Opioids Consumption	5 milligram (mg) Interval 0.0 to 20.0	10 milligram (mg) Interval 5.0 to 20.0

SECONDARY outcome

Timeframe: Participants' pain score was assessed on the first postoperative day after mastectomy

Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)

Outcome measures

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo
Pain Scores	4 units on a scale Interval 0.0 to 7.0	4 units on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Participants' pain score was assessed at hospital discharge, an average of 3 days after mastectomy

Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)

Outcome measures

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo
Pain Scores	4 units on a scale Interval 0.0 to 6.0	4 units on a scale Interval 0.0 to 7.0

SECONDARY outcome

Timeframe: Participants' pain score was assessed after discharge on the 7th day after mastectomy

Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)

Outcome measures

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo
Pain Scores	3 units on a scale Interval 0.0 to 5.0	3 units on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Participants' pain score was assessed after discharge on the 14th day after mastectomy

Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)

Outcome measures

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo
Pain Scores	3 units on a scale Interval 0.0 to 5.0	2 units on a scale Interval 0.0 to 8.0

SECONDARY outcome

Timeframe: Participants' pain score was assessed after discharge on the 30th day after mastectomy

Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)

Outcome measures

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo
Pain Scores	2 units on a scale Interval 0.0 to 5.0	2 units on a scale Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: Participants' pain score was assessed after discharge on the 90th day after mastectomy

Visual Analog Pain Scores (VAS); 0 (no pain) to 10 (worst possible pain)

Outcome measures

Measure	Pregabalin n=23 Participants pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 Participants placebo lyrica: 150mg of pregabalin/placebo
Pain Scores	1 units on a scale Interval 0.0 to 8.0	1 units on a scale Interval 0.0 to 5.0

Adverse Events

Pregabalin

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pregabalin n=23 participants at risk pregabalin (lyrica) lyrica: 150mg of pregabalin/placebo	Placebo n=24 participants at risk placebo lyrica: 150mg of pregabalin/placebo
Blood and lymphatic system disorders Surgical wound hematoma	4.3% 1/23 • Number of events 1 • 90 days after mastectomy	4.2% 1/24 • Number of events 1 • 90 days after mastectomy
Respiratory, thoracic and mediastinal disorders Desaturation in the operating room	4.3% 1/23 • Number of events 1 • 90 days after mastectomy	0.00% 0/24 • 90 days after mastectomy
Skin and subcutaneous tissue disorders Erythema and streaking of left breast skin	4.3% 1/23 • Number of events 1 • 90 days after mastectomy	0.00% 0/24 • 90 days after mastectomy
Surgical and medical procedures Wound debridement	0.00% 0/23 • 90 days after mastectomy	4.2% 1/24 • Number of events 1 • 90 days after mastectomy
Reproductive system and breast disorders Micrometastases to axilla	4.3% 1/23 • Number of events 1 • 90 days after mastectomy	0.00% 0/24 • 90 days after mastectomy
Blood and lymphatic system disorders Anemia	0.00% 0/23 • 90 days after mastectomy	4.2% 1/24 • Number of events 1 • 90 days after mastectomy
Surgical and medical procedures Nerve injury	0.00% 0/23 • 90 days after mastectomy	4.2% 1/24 • Number of events 1 • 90 days after mastectomy

Other adverse events

Adverse event data not reported

Additional Information

Babatunde Ogunnaike

UTexas Southwestern Medical Center

Phone: (214) 590

Email: Babatunde.Ogunnaike@UTSouthwestern.edu

Results disclosure agreements

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