The study evaluate the quality of epidural anaesthesia and the safety of Chloroprocaine HCl 3% compared with Ropivacaine HCl 0.75% in patients with an epidural catheter in situ undergoing unplanned Caesarean section.
Labouring women who have an epidural catheter in situ and established analgesia, in need of an unplanned Caesarean section, will be randomly allocated to receive either Chloroprocaine HCl 3% (T-group) or Ropivacaine HCl 0.75% (R-group) epidurally. Prior to the epidural injection, the patient will be transferred to the operating theatre. The local anaesthetic solution will be freshly prepared and 20 mL will be administered by epidural injection, according to the standard hospital procedures, as detailed in the "Study Schedule" section below. Time T0 is defined as the start time of the first epidural injection of the investigational product. In case of pain or discomfort, a 6 mL epidural top-up of the same anaesthetic, i.e. Chloroprocaine HCl 3% in T-group and Ropivacaine HCl 0.75% in R-group, will be administered. The anaesthesiologist(s) administering the anaesthetic and collecting the data will be blinded with respect to the treatment given to each patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
16
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.
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.
UZ Leuven, campus Gasthuisberg
Leuven, Belgium
Time to the Onset of Anaesthesia
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.
Time frame: Up to 1 hour after last epidural injection
Time From T0 to Loss Light Touch Sensation
Time from T0 to loss light touch sensation to the metameric level T5 (block to T5), bilateral
Time frame: Up to 1 hour after last epidural injection
Quality of the Block
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)
Time frame: Quality of the block assessed between 10 and 20 minutes after the end of surgery
Maximum Metameric Level of the Sensory Block
Maximum metameric level of the sensory block assessed by three modalities (complete loss of cold, pinprick and light touch sensation)
Time frame: Up to 1 hrs after last epidural injection
Motor Block Assessment
Motor block assessment (modified Bromage scale) at baseline, prior to incision and after surgery
Time frame: Up to 12 hours after surgery
Proportion of Patients Who Need Top-up Anaesthesia
Proportion of patients who need top-up epidural anaesthesia (same anaesthetic as first epidural injection)
Time frame: Up to 2 hours after last epidural injection
Proportion of Patients Who Need Supplementation of Opioids
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Proportion of patients who need supplementation of the block intraoperatively with intravenous opioids
Time frame: Up to 2 hours after last epidural injection
Proportion of Patients Who Need General Anaesthesia
Proportion of patients who need general anaesthesia
Time frame: Up to 2 hours after last epidural injection
Discomfort and Pain During Surgery
Discomfort and pain assessed during surgery through spontaneous patient's reporting and questioning by the Investigator/anaesthesiologist
Time frame: Up to 2 hours after last epidural injection
First Breakthrough Pain
First breakthrough pain assessed by the patient, recorded on a 0-10 cm VAS (0=no pain, 10= most severe pain imaginable)
Time frame: Up to 12 hours after surgery
Maternal Treatment-emergent Adverse Events
Maternal treatment-emergent adverse events, with particular attention to pain (see above), pruritus, nausea, vomiting
Time frame: Up to day 3±1 after surgery
Pulse Rate
Maternal pulse rate
Time frame: Up to 12 hours after surgery
Oximetry
Maternal pulse oximetry (SpO2)
Time frame: Up to 12 hours after surgery
Electrocardiogram
Maternal electrocardiogram
Time frame: Up to 12 hours after surgery
Total Dose of Phenylephrine
Total dose (μg) of phenylephrine
Time frame: Up to 2 hours after last epidural injection
Total Dose of Atropine
Total dose (mg) of atropine
Time frame: Up to 2 hours after last epidural injection
Intravenous Fluids
Total volume (ml) of intravenous fluids
Time frame: Up to 12 hours after surgery
Neonate Apgar
Neonate Apgar scores at 1 and 5 minutes
Time frame: 1 and 5 minutes after birth
Foetal Hypoxic Stress
Indication of foetal hypoxic stress
Time frame: Up to 12 hours after surgery
Pain at the Site of 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)
Time frame: Up to 12 hours after surgery
Pain at the Site of Epidural Injection
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)
Time frame: Up to 12 hours after surgery
Concomitant Medications
Maternal concomitant medications
Time frame: Up to day 3±1 after surgery
Neonatal Adverse Events
Neonatal adverse events
Time frame: Up to day 3±1 after surgery