Trial Outcomes & Findings for Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section (NCT NCT02919072)

Results Overview

The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

16 participants

Primary outcome timeframe

Up to 1 hour after last epidural injection

Results posted on

2023-11-21

Participant Flow

Due to difficulties in enrolling patients, the enrolment stopped prematurely, and only 16 patients were screened and randomised (only at site N. 001).

Participant milestones

Participant milestones
Measure	Chloroprocaine Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.	Ropivacaine Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
Overall Study STARTED	8	8
Overall Study COMPLETED	8	8
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Chloroprocaine 3% - Epidural Anesthesia in Unplanned Caesarean Section

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Chloroprocaine n=8 Participants Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.	Ropivacaine n=8 Participants Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.	Total n=16 Participants Total of all reporting groups
Age, Continuous	28.8 years STANDARD_DEVIATION 5.6 • n=5 Participants	33.3 years STANDARD_DEVIATION 7.5 • n=7 Participants	31.05 years STANDARD_DEVIATION 6.55 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Belgium	8 participants n=5 Participants	8 participants n=7 Participants	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 1 hour after last epidural injection

The time from T0 (start time of the epidural injection) to complete loss of cold sensation to the metameric level T4 (block to T4), bilateral.

Outcome measures

Outcome measures
Measure	Chloroprocaine n=6 Participants Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.	Ropivacaine n=7 Participants Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
Time to the Onset of Anaesthesia	9 minutes Standard Deviation 5.8	9.1 minutes Standard Deviation 4

SECONDARY outcome

Timeframe: Up to 1 hour after last epidural injection

Time from T0 to loss light touch sensation to the metameric level T5 (block to T5), bilateral

Outcome measures

Outcome measures
Measure	Chloroprocaine n=3 Participants Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.	Ropivacaine n=6 Participants Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
Time From T0 to Loss Light Touch Sensation	9.3 minutes Standard Deviation 9.2	13.3 minutes Standard Deviation 4.1

SECONDARY outcome

Timeframe: Quality of the block assessed between 10 and 20 minutes after the end of surgery

Quality of the block assessed between 10 and 20 min after the end of surgery by the anaesthesiologist and patient together using a 0-10 cm visual analogue scale (VAS; 10=excellent anaesthetic quality, 0=very poor anaesthetic quality)

Outcome measures

Outcome measures
Measure	Chloroprocaine n=6 Participants Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.	Ropivacaine n=7 Participants Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
Quality of the Block	9.8 units on a scale Standard Deviation 0.4	8.4 units on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: Up to 1 hrs after last epidural injection

Maximum metameric level of the sensory block assessed by three modalities (complete loss of cold, pinprick and light touch sensation)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

Motor block assessment (modified Bromage scale) at baseline, prior to incision and after surgery

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 hours after last epidural injection

Proportion of patients who need top-up epidural anaesthesia (same anaesthetic as first epidural injection)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 hours after last epidural injection

Proportion of patients who need supplementation of the block intraoperatively with intravenous opioids

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 hours after last epidural injection

Proportion of patients who need general anaesthesia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 hours after last epidural injection

Discomfort and pain assessed during surgery through spontaneous patient's reporting and questioning by the Investigator/anaesthesiologist

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

First breakthrough pain assessed by the patient, recorded on a 0-10 cm VAS (0=no pain, 10= most severe pain imaginable)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to day 3±1 after surgery

Maternal treatment-emergent adverse events, with particular attention to pain (see above), pruritus, nausea, vomiting

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

Maternal pulse rate

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

Maternal pulse oximetry (SpO2)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

Maternal electrocardiogram

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 hours after last epidural injection

Total dose (μg) of phenylephrine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 hours after last epidural injection

Total dose (mg) of atropine

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

Total volume (ml) of intravenous fluids

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 1 and 5 minutes after birth

Neonate Apgar scores at 1 and 5 minutes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

Indication of foetal hypoxic stress

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

Pain at the site of surgery at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=most severe pain imaginable)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 hours after surgery

Pain at the site of epidural injection at final visit/early termination visit, recorded on a 0-10 cm VAS (0=no pain, 10=severe pain)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to day 3±1 after surgery

Maternal concomitant medications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to day 3±1 after surgery

Neonatal adverse events

Outcome measures

Outcome data not reported

Adverse Events

Chloroprocaine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Ropivacaine

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Chloroprocaine n=8 participants at risk Chloroprocaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Chloroprocaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.	Ropivacaine n=8 participants at risk Ropivacaine, 20 ml epidural anaesthetic solution administered according to the standard procedures of the hospital. In case of pain or discomfort, a 6 mL epidural top-up will be administered. Ropivacaine: The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
Vascular disorders Hypotensio	62.5% 5/8 • Number of events 5 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	87.5% 7/8 • Number of events 8 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Injury, poisoning and procedural complications post lumbar puncture syndrom	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	0.00% 0/8 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Injury, poisoning and procedural complications POst procedural disconfort	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	0.00% 0/8 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Injury, poisoning and procedural complications procedural nausea	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	0.00% 0/8 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Injury, poisoning and procedural complications procedural pain	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	25.0% 2/8 • Number of events 2 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Gastrointestinal disorders dysphagia	0.00% 0/8 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Gastrointestinal disorders vomiting	0.00% 0/8 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Gastrointestinal disorders nausea	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Blood and lymphatic system disorders anemia	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	25.0% 2/8 • Number of events 2 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Infections and infestations urinary tract infection	0.00% 0/8 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1
Skin and subcutaneous tissue disorders skin lesion	0.00% 0/8 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1	12.5% 1/8 • Number of events 1 • Maternal AEs will be assessed throughout the study from the signature of the informed consent up to follow-up Visit Day 3±1

Additional Information

Anna Guaita

Sintetica SA

Phone: +41 (0)91640 42 50

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place