Trial Outcomes & Findings for Preoperative Pain Control in Gastric Bypass Surgery Patients (NCT NCT01801189)

NCT ID: NCT01801189

Last Updated: 2022-07-14

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 61 participants
• Primary outcome timeframe: Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.
• Results posted on: 2022-07-14

Participant Flow

Participant milestones

Measure	Pregabalin Single, 300 mg pre-operative oral dose of Pregabalin. Pregabalin: One 300 mg oral dose of Pregabalin given before surgery.	Sugar Pill Single, placebo pre-operative dose. Placebo (for Pregabalin): One oral dose of placebo given before surgery.
Overall Study STARTED	28	33
Overall Study COMPLETED	28	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Pregabalin n=28 Participants Single, 300 mg pre-operative oral dose of Pregabalin. Pregabalin: One 300 mg oral dose of Pregabalin given before surgery.	Sugar Pill n=33 Participants Single, placebo pre-operative dose. Placebo (for Pregabalin): One oral dose of placebo given before surgery.	Total n=61 Participants Total of all reporting groups
Age, Continuous	48.89 years STANDARD_DEVIATION 9.77 • n=28 Participants	50.74 years STANDARD_DEVIATION 13.66 • n=33 Participants	49.91 years STANDARD_DEVIATION 12.10 • n=61 Participants
Sex: Female, Male Female	20 Participants n=28 Participants	26 Participants n=33 Participants	46 Participants n=61 Participants
Sex: Female, Male Male	8 Participants n=28 Participants	7 Participants n=33 Participants	15 Participants n=61 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: Morphine milligram equivalent opioid requirements on post op days zero, 1, and 2.

Outcome measures

Measure	Pregabalin n=28 Participants Single, 300 mg pre-operative oral dose of Pregabalin. Pregabalin: One 300 mg oral dose of Pregabalin given before surgery.	Sugar Pill n=33 Participants Single, placebo pre-operative dose. Placebo (for Pregabalin): One oral dose of placebo given before surgery.
Post-operative Pain Medication Requirements POD 0	13.76 MME Standard Deviation 11.61	17.32 MME Standard Deviation 9.15
Post-operative Pain Medication Requirements POD 1	40.89 MME Standard Deviation 28.71	46.63 MME Standard Deviation 30.67
Post-operative Pain Medication Requirements POD 2	33.62 MME Standard Deviation 27.6	29.74 MME Standard Deviation 26.08

SECONDARY outcome

Timeframe: Days in hospital following surgical procedure, up to 5 days

Length of stay in days after surgical procedure

Outcome measures

Measure	Pregabalin n=28 Participants Single, 300 mg pre-operative oral dose of Pregabalin. Pregabalin: One 300 mg oral dose of Pregabalin given before surgery.	Sugar Pill n=33 Participants Single, placebo pre-operative dose. Placebo (for Pregabalin): One oral dose of placebo given before surgery.
Length of Stay	2.19 Days Standard Deviation 0.47	2.24 Days Standard Deviation 0.6

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sugar Pill

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. Valerie Halpin

Legacy Weight and Diabetes Institute

Phone: 503-413-7557

Email: vhalpin@lhs.org

Results disclosure agreements

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