Trial Outcomes & Findings for Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty (NCT NCT03838874)

NCT ID: NCT03838874

Last Updated: 2021-08-12

Results Overview

Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 154 participants
• Primary outcome timeframe: Post surgery, approximately 1 day
• Results posted on: 2021-08-12

Participant Flow

Participant milestones

Measure	Low-Dose Bupivacaine Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Overall Study STARTED	80	74
Overall Study COMPLETED	80	74
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	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic	Total n=154 Participants Total of all reporting groups
Age, Continuous	67.9 years STANDARD_DEVIATION 11.8 • n=80 Participants	67.9 years STANDARD_DEVIATION 9.2 • n=74 Participants	67.9 years STANDARD_DEVIATION 10 • n=154 Participants
Sex: Female, Male Female	46 Participants n=80 Participants	42 Participants n=74 Participants	88 Participants n=154 Participants
Sex: Female, Male Male	34 Participants n=80 Participants	32 Participants n=74 Participants	66 Participants n=154 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	80 participants n=80 Participants	74 participants n=74 Participants	154 participants n=154 Participants

PRIMARY outcome

Timeframe: Post surgery, approximately 1 day

Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Time to Return of Lower Extremity Motor Function	210.3 minutes Standard Deviation 79.54	184.7 minutes Standard Deviation 47.8

SECONDARY outcome

Timeframe: Time of discharge, approximately 1-2 days

Number of minutes subjects were admitted to PACU following the surgical procedure

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Post-Anesthesia Care Unit (PACU) Length of Stay	65.2 minutes Standard Deviation 33.6	75.0 minutes Standard Deviation 39.3

SECONDARY outcome

Timeframe: Time of discharge, approximately 1-2 days

Number days subjects were admitted to the hospital following the surgical procedure

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Hospital Length of Stay	1.5 days Standard Deviation 0.9	1.4 days Standard Deviation 0.8

SECONDARY outcome

Timeframe: 24 hours following the surgical procedure

Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Maximum Pain Score	6.0 score on a scale Standard Deviation 2.5	6.5 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 24 hours following the surgical procedure

Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Median Pain Score	3.4 score on a scale Standard Deviation 1.9	3.4 score on a scale Standard Deviation 1.6

SECONDARY outcome

Timeframe: Time of discharge, approximately 1-2 days

Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Discharge Pain Score	3.5 score on a scale Standard Deviation 2.1	3.5 score on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: Time of discharge, approximately 1-2 days

Number of participants to experience orthostatic hypotension following the surgical procedure.

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Orthostatic Hypotension	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Time of discharge, approximately 1-2 days

Number of participants to experience urinary retention follow the surgical procedure.

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Urinary Retention	10 Participants	10 Participants

SECONDARY outcome

Timeframe: One week post-operative

Number of participants to report transient neurologic symptoms

Outcome measures

Measure	Low-Dose Bupivacaine n=80 Participants Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic	Mepivacaine n=74 Participants Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA. Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
Transient Neurologic Symptoms	0 Participants	0 Participants

Adverse Events

Low-Dose Bupivacaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mepivacaine

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. Matthew Abdel

Mayo Clinic

Phone: 507-538-1296

Email: Abdel.Matthew@mayo.edu

Results disclosure agreements

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