Trial Outcomes & Findings for Observational Study on 2-chloroprocaine Hydrochloride 1% (NCT NCT02067806)

NCT ID: NCT02067806

Last Updated: 2021-06-29

Results Overview

Number of Participants with neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome(CES).

• Recruitment status: COMPLETED
• Target enrollment: 394 participants
• Primary outcome timeframe: assessed at 24h and 7(-1/+2) days after surgery, total reported
• Results posted on: 2021-06-29

Participant Flow

Participant milestones

Measure	Chloroprocaine 1% Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
Overall Study STARTED	394
Overall Study COMPLETED	387
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Observational Study on 2-chloroprocaine Hydrochloride 1%

Baseline characteristics by cohort

Measure	Chloroprocaine 1% n=393 Participants intrathecal anesthesia with 1% solution of 2-chloroprocaine hydrochloride in patients undergoing short surgical procedures (max. 40 minutes).
Age, Continuous	51.5 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	158 Participants n=5 Participants
Sex: Female, Male Male	235 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	388 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants
Region of Enrollment Belgium	200 participants n=5 Participants
Region of Enrollment Germany	139 participants n=5 Participants
Region of Enrollment France	54 participants n=5 Participants
BMI	27.4 kg/m^2 STANDARD_DEVIATION 5 • n=5 Participants

PRIMARY outcome

Timeframe: assessed at 24h and 7(-1/+2) days after surgery, total reported

Number of Participants with neurological adverse events, with particular attention to Transient Neurological Symptoms (TNS) and Cauda Equina Syndrome(CES).

Outcome measures

Measure	Chloroprocaine 1% n=393 Participants Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
Number of Participants With Adverse Events 24 hours	9 participants
Number of Participants With Adverse Events 7 days	5 participants

PRIMARY outcome

Timeframe: 24 hours

the follow-up questionnaires are foreseen, at 24 h after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 24 h after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed.

Outcome measures

Measure	Chloroprocaine 1% n=393 Participants Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours fatigue	4 number of patients
Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours nausea/vomiting	3 number of patients
Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours dizziness	1 number of patients
Number of Participants With Symptoms in Follow-Up Questionnaire at 24 Hours urin/defec problems	1 number of patients

PRIMARY outcome

Timeframe: 7 days

the follow-up questionnaires are foreseen, at 7 days after time of spinal injection (Tsp), to gather all possible neurological adverse events. About 7 days after surgery (indicated as Tsp),Investigator or a deputy will question patients about neurological symptoms and pain not associated to the operation area on the basis of the follow-up questionnaires and giving a score between 0 to 10 to the pain intensity. All other adverse events will also be assessed.

Outcome measures

Measure	Chloroprocaine 1% n=393 Participants Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days fatigue	3 number of patients
Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days nausea/vomiting	1 number of patients
Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days dizziness	1 number of patients
Number of Participants With Symptoms in Follow-Up Questionnaire at 7 Days urin/defec problems	2 number of patients

Adverse Events

Chloroprocaine 1%

Serious events: 0 serious events

Other events: 37 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Chloroprocaine 1% n=393 participants at risk Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
Cardiac disorders bradycardia	1.0% 4/393 • Number of events 4 • 7 days
Gastrointestinal disorders vomiting	0.51% 2/393 • Number of events 2 • 7 days
General disorders drug effect incomplete	1.0% 4/393 • Number of events 4 • 7 days
General disorders drug ineffective	0.25% 1/393 • Number of events 1 • 7 days
General disorders injection site pain	0.25% 1/393 • Number of events 1 • 7 days
Injury, poisoning and procedural complications anesthetic complication	0.76% 3/393 • Number of events 3 • 7 days
Injury, poisoning and procedural complications Incision site haemorrhage	0.25% 1/393 • Number of events 1 • 7 days
Injury, poisoning and procedural complications incision site pain	0.25% 1/393 • Number of events 1 • 7 days
Injury, poisoning and procedural complications Post lumbar puncture syndrome	1.5% 6/393 • Number of events 6 • 7 days
Injury, poisoning and procedural complications Procedural hypotension	0.25% 1/393 • Number of events 1 • 7 days
Musculoskeletal and connective tissue disorders myalgia	0.25% 1/393 • Number of events 1 • 7 days
Nervous system disorders burning sensation	0.25% 1/393 • Number of events 1 • 7 days
Nervous system disorders headache	0.25% 1/393 • Number of events 1 • 7 days
Nervous system disorders Hypoaesthesia	0.51% 2/393 • Number of events 2 • 7 days
Nervous system disorders hypotonia	0.51% 2/393 • Number of events 2 • 7 days
Nervous system disorders paresthesia	1.0% 4/393 • Number of events 4 • 7 days
Respiratory, thoracic and mediastinal disorders hyprventilation	0.25% 1/393 • Number of events 1 • 7 days
Vascular disorders hypotension	3.3% 13/393 • Number of events 13 • 7 days

Additional Information

Dr.Elisabetta Donati, Corporate Director Scientific Affairs

Sintetica SA

Phone: +41.91.640.42.50

Email: edonati@sintetica.com

Results disclosure agreements

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