Trial Outcomes & Findings for 1% Chloroprocaine(PF) vs. Bupivacaine Spinals (NCT NCT03324984)
NCT ID: NCT03324984
Last Updated: 2025-02-28
Results Overview
For this study Recovery time was defined as the time (in minutes) to return of both motor and sensory function, postoperatively. The return of motor function was tested by demonstrating mobility in both lower extremities including hips, knees, and lower legs using the Bromage scale. The return of sensory function was assessed using light touch and/or pinprick techniques on the dermatomes corresponding with the T8-S2 spinal cord segments. The duration in minutes when both sensory and motor function were re-established was documented and results were summarized by study arm using basic descriptive statistics. In this study it is hypothesized that use of 1% Chloroprocaine spinal anesthesia will reduce recovery times of patients undergoing anorectal procedures as compared to 0.75% bupivacaine spinal.
COMPLETED
PHASE2
110 participants
On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours
2025-02-28
Participant Flow
Between September 2019 and February 2023, a total of 110 eligible patients were randomized and 55 were assigned to each treatment group, 1% Chloroprocaine or 0.75% Bupivacaine. Study was paused from March 2020 to September 2020 due to the pandemic and was also paused December 2020 because the surgery center was closed and the pharmacy was unable to obtain the necessary medications from the manufacturer.
Participant milestones
| Measure |
1% Chloroprocaine (PF)
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
|
0.75% Bupivacaine
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
0.75% bupivacaine: Bupivacaine is used on label
|
|---|---|---|
|
Overall Study
STARTED
|
55
|
55
|
|
Overall Study
COMPLETED
|
54
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
1% Chloroprocaine (PF)
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
|
0.75% Bupivacaine
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
0.75% bupivacaine: Bupivacaine is used on label
|
|---|---|---|
|
Overall Study
Inability to place a spinal anesthesia due to the patients' anatomy
|
1
|
4
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1% Chloroprocaine (PF)
n=54 Participants
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
|
0.75% Bupivacaine
n=51 Participants
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
0.75% bupivacaine: Bupivacaine is used on label
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
n=54 Participants
|
48.0 years
n=51 Participants
|
49.3 years
n=105 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=54 Participants
|
21 Participants
n=51 Participants
|
40 Participants
n=105 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=54 Participants
|
30 Participants
n=51 Participants
|
65 Participants
n=105 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
54 participants
n=54 Participants
|
51 participants
n=51 Participants
|
105 participants
n=105 Participants
|
|
American Society of Anesthesiologists Physical Status (ASA-PS) Classification
Class I
|
0 Participants
n=54 Participants
|
4 Participants
n=51 Participants
|
4 Participants
n=105 Participants
|
|
American Society of Anesthesiologists Physical Status (ASA-PS) Classification
Class II
|
40 Participants
n=54 Participants
|
37 Participants
n=51 Participants
|
77 Participants
n=105 Participants
|
|
American Society of Anesthesiologists Physical Status (ASA-PS) Classification
Class III
|
14 Participants
n=54 Participants
|
10 Participants
n=51 Participants
|
24 Participants
n=105 Participants
|
|
Body Mass Index (BMI)
|
29.1 kg/m^2
n=54 Participants
|
28.1 kg/m^2
n=51 Participants
|
28.6 kg/m^2
n=105 Participants
|
|
Surgical Procedure
Ablation
|
24 Participants
n=54 Participants
|
22 Participants
n=51 Participants
|
46 Participants
n=105 Participants
|
|
Surgical Procedure
Anal Fissurectomy
|
8 Participants
n=54 Participants
|
5 Participants
n=51 Participants
|
13 Participants
n=105 Participants
|
|
Surgical Procedure
Debridement
|
6 Participants
n=54 Participants
|
8 Participants
n=51 Participants
|
14 Participants
n=105 Participants
|
|
Surgical Procedure
Exam Under Anesthesia
|
8 Participants
n=54 Participants
|
3 Participants
n=51 Participants
|
11 Participants
n=105 Participants
|
|
Surgical Procedure
Hemorrhoidectomy
|
7 Participants
n=54 Participants
|
12 Participants
n=51 Participants
|
19 Participants
n=105 Participants
|
|
Surgical Procedure
Other
|
1 Participants
n=54 Participants
|
1 Participants
n=51 Participants
|
2 Participants
n=105 Participants
|
PRIMARY outcome
Timeframe: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hoursFor this study Recovery time was defined as the time (in minutes) to return of both motor and sensory function, postoperatively. The return of motor function was tested by demonstrating mobility in both lower extremities including hips, knees, and lower legs using the Bromage scale. The return of sensory function was assessed using light touch and/or pinprick techniques on the dermatomes corresponding with the T8-S2 spinal cord segments. The duration in minutes when both sensory and motor function were re-established was documented and results were summarized by study arm using basic descriptive statistics. In this study it is hypothesized that use of 1% Chloroprocaine spinal anesthesia will reduce recovery times of patients undergoing anorectal procedures as compared to 0.75% bupivacaine spinal.
Outcome measures
| Measure |
1% Chloroprocaine (PF)
n=54 Participants
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
|
0.75% Bupivacaine
n=51 Participants
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
0.75% bupivacaine: Bupivacaine is used on label
|
|---|---|---|
|
Recovery Time
|
134.1 minutes
Standard Error 8.6
|
161.9 minutes
Standard Error 10.3
|
PRIMARY outcome
Timeframe: On post-operative day 1 (POD1), up to 24 hoursFor this study discharge time is defined as the time (in minutes) when the patient is "fit to discharge" from the Postoperative Care Unit (PACU). At the institution where this study took place "fit to discharge" was defined as the ability to void and the ability to ambulate unassisted for at least 10 feet. The duration of time when a patient was able to do both was documented. Results were summarized by study arm using basic descriptive statistics. It is hypothesized that the use of 1% Chloroprocaine spinal anesthesia will result in a clinically significant 30% reduction in discharge times of patients as compared to 0.75% bupivacaine spinal.
Outcome measures
| Measure |
1% Chloroprocaine (PF)
n=54 Participants
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
|
0.75% Bupivacaine
n=51 Participants
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
0.75% bupivacaine: Bupivacaine is used on label
|
|---|---|---|
|
Discharge Time
|
191.4 minutes
Standard Error 6.6
|
230.9 minutes
Standard Error 9.4
|
SECONDARY outcome
Timeframe: On day of procedure, 0-5 minutes following administration of spinal anesthesiaEvidence of hypotension will be documented if systolic blood pressure (SBP) drops more than 20mmHg from baseline following spinal anesthesia. Hypotension is a common side effect of spinal anesthesia (SA). The number of participants with evidence of hypotension will be summarized by study arm.
Outcome measures
| Measure |
1% Chloroprocaine (PF)
n=54 Participants
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
|
0.75% Bupivacaine
n=51 Participants
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
0.75% bupivacaine: Bupivacaine is used on label
|
|---|---|---|
|
Evidence of Hypotension
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: On post-op day 2, approximately 24 hours post operationThe number of participants demonstrating TNS approximately 24 hours following the procedure will be assessed. TNS will be defined as back pain or dysesthesia that radiated to the buttocks, thighs, hips, or calves and began within the first 24 hours after surgery. Localized pain or tenderness at the injection site or lower back without radiation will not be considered TNS. TNS is clinically important as it causes patient pain and discomfort and, in severe cases, may delay discharge or cause readmission. Symptoms will be summarized and reported by study arm.
Outcome measures
| Measure |
1% Chloroprocaine (PF)
n=54 Participants
1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
|
0.75% Bupivacaine
n=51 Participants
0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
0.75% bupivacaine: Bupivacaine is used on label
|
|---|---|---|
|
Evidence of Transient Neurological Symptoms (TNS)
|
0 Participants
|
0 Participants
|
Adverse Events
1% Chloroprocaine (PF)
0.75% Bupivacaine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place