Trial Outcomes & Findings for 3 Local Anesthetics for Spinal Anesthesia in Primary Total Hip Arthroplasty (NCT NCT03948386)

Results Overview

Is there a difference between isobaric mepivacaine, hyperbaric bupivacaine, and isobaric bupivacaine when used for spinal anesthesia in primary total hip replacement in percentage of patients that can ambulate within 3.5 hours after spinal anesthesia?

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

159 participants

Primary outcome timeframe

3.5 hours

Results posted on

2021-05-07

Participant Flow

One patient assigned to isobaric bupivacaine received hyperbaric bupivacaine (miscommunication); two patients assigned to mepivacaine did not receive correct drug from miscommunication; and one patient assigned to hyperbaric bupivacaine was given the wrong drug from miscommunication. One patient assignment information is unclear.

Participant milestones

Participant milestones
Measure	Isobaric Bupivacaine Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
Overall Study STARTED	52	54	53
Overall Study COMPLETED	51	53	50
Overall Study NOT COMPLETED	1	1	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Isobaric Bupivacaine n=51 Participants Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine n=53 Participants hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: TThe anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine n=50 Participants isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Total n=154 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=51 Participants	0 Participants n=53 Participants	0 Participants n=50 Participants	0 Participants n=154 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=51 Participants	19 Participants n=53 Participants	21 Participants n=50 Participants	64 Participants n=154 Participants
Age, Categorical >=65 years	27 Participants n=51 Participants	34 Participants n=53 Participants	29 Participants n=50 Participants	90 Participants n=154 Participants
Age, Continuous	66 years STANDARD_DEVIATION 9 • n=51 Participants	67 years STANDARD_DEVIATION 8 • n=53 Participants	67 years STANDARD_DEVIATION 8 • n=50 Participants	67 years STANDARD_DEVIATION 8 • n=154 Participants
Sex: Female, Male Female	28 Participants n=51 Participants	28 Participants n=53 Participants	22 Participants n=50 Participants	78 Participants n=154 Participants
Sex: Female, Male Male	23 Participants n=51 Participants	25 Participants n=53 Participants	28 Participants n=50 Participants	76 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	51 Participants n=51 Participants	53 Participants n=53 Participants	50 Participants n=50 Participants	154 Participants n=154 Participants

PRIMARY outcome

Timeframe: 3.5 hours

Is there a difference between isobaric mepivacaine, hyperbaric bupivacaine, and isobaric bupivacaine when used for spinal anesthesia in primary total hip replacement in percentage of patients that can ambulate within 3.5 hours after spinal anesthesia?

Outcome measures

Outcome measures
Measure	Isobaric Bupivacaine n=51 Participants Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine n=53 Participants hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine n=50 Participants isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
Percentage Ambulating Early After Spinal Anesthesia	9 Participants	20 Participants	35 Participants

SECONDARY outcome

Timeframe: Postoperative day 0 (day of surgery)

time to return of motor function of the thigh and lower leg

Outcome measures

Outcome measures
Measure	Isobaric Bupivacaine n=51 Participants Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine n=53 Participants hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine n=50 Participants isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
Return of Motor Function of the Thigh and Lower Leg	148 minutes Interval 120.0 to 205.0	123 minutes Interval 88.0 to 188.0	109 minutes Interval 74.0 to 156.0

SECONDARY outcome

Timeframe: Postoperative day 2

Population: 2 patients with missing data

number of patients with dizziness when transitioning from lying down to sitting or standing

Outcome measures

Outcome measures
Measure	Isobaric Bupivacaine n=51 Participants Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine n=52 Participants hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine n=49 Participants isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
Number of Patients With Dizziness Events	11 Participants	7 Participants	9 Participants

SECONDARY outcome

Timeframe: postoperative day 1

Population: 3 patients with missing data

number of patients with inability to urinate within 8 hours of surgery OR a report of distended or painful bladder occurring on postoperative day 0 or 1, either by patient report or on palpation by nursing

Outcome measures

Outcome measures
Measure	Isobaric Bupivacaine n=49 Participants Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine n=52 Participants hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine n=50 Participants isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
Number of Patients With Urinary Retention Events	6 Participants	8 Participants	5 Participants

SECONDARY outcome

Timeframe: Postoperative days 0-2

Population: Number of patients experiencing TNS at any time.

Number of patients with TNS events occurring. Transient neurological symptoms were defined as new onset of back, buttock, or thigh pain occurring after spinal anesthesia.

Outcome measures

Outcome measures
Measure	Isobaric Bupivacaine n=51 Participants Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine n=53 Participants hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine n=50 Participants isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
Number of Patients With Transient Neurological Symptoms (TNS)	2 Participants	6 Participants	5 Participants

SECONDARY outcome

Timeframe: hospital stay (0-3 days)

length of hospital stay

Outcome measures

Outcome measures
Measure	Isobaric Bupivacaine n=51 Participants Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine n=53 Participants hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine n=50 Participants isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
Hospital Stay	26 hours Interval 21.0 to 28.0	26 hours Interval 23.0 to 29.0	22 hours Interval 9.0 to 26.0

Adverse Events

Isobaric Bupivacaine

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Hyperbaric Bupivacaine

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Isobaric Mepivacaine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Isobaric Bupivacaine n=51 participants at risk Isobaric bupivacaine 12.5 mg (2.5 cc of 0.5%) for ≤ 74" height and 15 mg (3 cc) for \> 74" height isobaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Hyperbaric Bupivacaine n=53 participants at risk hyperbaric bupivacaine 10.25 mg (1.5 cc 0.75%) for ≤ 74" height and 13.125 mg (1.75 cc) for \> 74" height hyperbaric bupivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.	Isobaric Mepivacaine n=50 participants at risk isobaric mepivacaine 52.5 mg (3.5 cc of 1.5%) for ≤ 74" height and 60 mg (4 cc) for \> 74" height isobaric mepivacaine: The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
Nervous system disorders Transient neurologic symptoms	3.9% 2/51 • 3 days	11.3% 6/53 • 3 days	10.0% 5/50 • 3 days

Additional Information

Eric S Schwenk, MD

Thomas Jefferson University

Phone: 215-955-6161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place