Trial Outcomes & Findings for Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery (NCT NCT03414359)

Last Updated: 2020-04-13

Results Overview

The onset time to surgical anesthesia, as reported by the participant using a standard procedure This will be measured by the time taken from the end of the epidural loading dose to develop a loss of touch sensation using a neurotip® (Owen Mumford, USA) device bilaterally at the T7 dermatomal level using a non-inferiority study design. A non-inferiority limit of 3 minutes was chosen apriori.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

70 participants

Primary outcome timeframe

Up to 35 minutes

Results posted on

2020-04-13

Participant Flow

Participant milestones

Participant milestones
Measure	2% Lidocaine 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)	3% Chloroprocaine 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
Overall Study STARTED	35	35
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	2% Lidocaine 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)	3% Chloroprocaine 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
Overall Study Lack of Efficacy	1	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

Comparison of Chloroprocaine vs Lidocaine for Epidural Anesthesia in Cesarean Delivery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	2% Lidocaine n=34 Participants 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)	3% Chloroprocaine n=33 Participants 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)	Total n=67 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	34 Participants n=93 Participants	33 Participants n=4 Participants	67 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	27 years n=93 Participants	30 years n=4 Participants	28 years n=27 Participants
Sex: Female, Male Female	34 Participants n=93 Participants	33 Participants n=4 Participants	67 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race/Ethnicity, Customized African American	13 participants n=93 Participants	12 participants n=4 Participants	25 participants n=27 Participants
Race/Ethnicity, Customized Other	21 participants n=93 Participants	21 participants n=4 Participants	42 participants n=27 Participants
Region of Enrollment United States	34 participants n=93 Participants	33 participants n=4 Participants	67 participants n=27 Participants
BMI	31 kg/m^2 n=93 Participants	32 kg/m^2 n=4 Participants	31 kg/m^2 n=27 Participants
Gestational age	273 days n=93 Participants	273 days n=4 Participants	273 days n=27 Participants
Duration of epidural infusion	48 minutes n=93 Participants	49 minutes n=4 Participants	49 minutes n=27 Participants

PRIMARY outcome

Timeframe: Up to 35 minutes

Population: Per protocol analysis

Outcome measures

Outcome measures
Measure	2% Lidocaine n=34 Participants 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)	3% Chloroprocaine n=33 Participants 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
The Onset Time to Surgical Anesthesia	558 seconds Standard Deviation 269	655 seconds Standard Deviation 258

SECONDARY outcome

Timeframe: 1 hour

This requirement for any rescue medications to control discomfort or pain during CD

Outcome measures

Outcome measures
Measure	2% Lidocaine n=34 Participants 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)	3% Chloroprocaine n=33 Participants 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
Secondary Outcome: Number of Participants With Requirement for Intraoperative Analgesia Supplementation	4 Participants	7 Participants

Adverse Events

2% Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

3% Chloroprocaine

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	2% Lidocaine n=34 participants at risk 2% Lidocaine: 2% Lidocaine (with epinephrine, bicarbonate, and fentanyl) using a combined spinal-epidural (CSE)	3% Chloroprocaine n=33 participants at risk 3% Chloroprocaine: 3% Chloroprocaine using a combined spinal-epidural (CSE)
Nervous system disorders Post dural puncture headache	0.00% 0/34 • During inpatient admission, approximately three days local anesthetic systemic toxicity (LAST), post-dural puncture headache (PDPH) and high spinal (defined as upper limb weakness)	3.0% 1/33 • Number of events 1 • During inpatient admission, approximately three days local anesthetic systemic toxicity (LAST), post-dural puncture headache (PDPH) and high spinal (defined as upper limb weakness)

Additional Information

Nadir El Sharawi

UAMS

Phone: 5016866114

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place