Trial Outcomes & Findings for Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores (NCT NCT02840240)

NCT ID: NCT02840240

Last Updated: 2024-01-09

Results Overview

Multiple pain measurements (numeric rating scale ranges from 0 to 10, where 0 - no pain and 10 - worse imaginable pain) over 72 hours after the surgery will be summarized by computing time weighted average pain score for each patient

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 107 participants
• Primary outcome timeframe: Initial 72 hours after surgery or until discharge, whatever comes first.
• Results posted on: 2024-01-09

Participant Flow

Participant milestones

Measure	Gabapentin Enacarbil Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative	Placebo Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Placebo: 600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
Overall Study STARTED	56	51
Overall Study COMPLETED	28	32
Overall Study NOT COMPLETED	28	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Gabapentin Enacarbil on Opioid Consumption and Pain Scores

Baseline characteristics by cohort

Measure	Gabapentin Enacarbil n=28 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative	Placebo n=32 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Placebo: 600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative	Total n=60 Participants Total of all reporting groups
Age, Continuous	65 years STANDARD_DEVIATION 11 • n=5 Participants	66 years STANDARD_DEVIATION 9 • n=7 Participants	66 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian/white	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Height	169 cm STANDARD_DEVIATION 11 • n=5 Participants	169 cm STANDARD_DEVIATION 10 • n=7 Participants	169 cm STANDARD_DEVIATION 10 • n=5 Participants
Weight	90 kg STANDARD_DEVIATION 26 • n=5 Participants	90 kg STANDARD_DEVIATION 20 • n=7 Participants	90 kg STANDARD_DEVIATION 23 • n=5 Participants

PRIMARY outcome

Timeframe: Initial 72 hours after surgery or until discharge, whatever comes first.

Multiple pain measurements (numeric rating scale ranges from 0 to 10, where 0 - no pain and 10 - worse imaginable pain) over 72 hours after the surgery will be summarized by computing time weighted average pain score for each patient

Outcome measures

Measure	Gabapentin Enacarbil n=28 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative	Placebo n=32 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Placebo: 600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
Time Weighted Average Pain Score in Numerical Rating Scores	4.0 score on a scale Standard Deviation 1.6	4.1 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: Initial 72 hours after surgery or until discharge, whatever comes first.

The total dose of opioid administered in the PACU and floor including the background analgesia (PCA) and boluses. All opioids will be converted into mg intravenous (IV) morphine equivalent to standardize opioid consumption .

Outcome measures

Measure	Gabapentin Enacarbil n=28 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative	Placebo n=32 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Placebo: 600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
Cumulative Postoperative Opioid Consumption	4.0 mg Standard Deviation 1.6	4.1 mg Standard Deviation 1.7

SECONDARY outcome

Timeframe: within 90 days after surgery

Population: There were 5 participants in gabapentin enacarbil group and 4 in placebo group with missing value in this outcome.

Number of participants with persistent pain at 90 days after surgery

Outcome measures

Measure	Gabapentin Enacarbil n=23 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative	Placebo n=28 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Placebo: 600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
Number of Participants With Persistent Pain 90-day After Surgery	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Initial 72 hours after surgery

Postoperative nausea and vomiting (PONV) were recorded daily by nurses.

Outcome measures

Measure	Gabapentin Enacarbil n=28 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative	Placebo n=32 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Placebo: 600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
Postoperative Nausea and Vomiting (PONV) up to 72 Hours After Surgery	8 Participants	12 Participants

SECONDARY outcome

Timeframe: From the end of surgery to discharge

Duration of hospitalization (hours) was recorded from the end of surgery to discharge, and compared between groups on the medians.

Outcome measures

Measure	Gabapentin Enacarbil n=28 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative	Placebo n=32 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Placebo: 600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
Length of Hospital Stay in Hours	78 hours Interval 49.0 to 102.0	76 hours Interval 56.0 to 82.0

SECONDARY outcome

Timeframe: Initial 72 hours after surgery or shortly before hospital discharge.

Population: There were 3 participants in gabapentin enacarbil group and 1 in placebo group with missing value in this outcome.

Quality of Recovery (QoR-15) survey was assessed by blinded investigators at 72 hours after surgery or shortly before hospital discharge, whichever came first. It is a patient-reported outcome ranging from 0 to 150. The higher scale indicates better recovery.

Outcome measures

Measure	Gabapentin Enacarbil n=25 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive Gabapentin enacarbil for 5 days Gabapentin enacarbil: 600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative	Placebo n=31 Participants Patients going through elective hip or knee replacement surgery with spinal anesthesia will receive placebo for 5 days Placebo: 600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
Quality of Recovery (QoR-15) Score 72 Hours After Surgery	114 score on a scale Standard Deviation 19	118 score on a scale Standard Deviation 15

Adverse Events

Gabapentin Enacarbil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Fabio Rodriguez

Cleveland Clinic

Phone: 216444-9950

Email: rodrigf3@ccf.org

Results disclosure agreements

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