ESPB vs Intrathecal Morphine for Assessements of Quality of Recovery After Cesarean Section
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorAUSL Romagna Rimini
About this trial
Cesarean section is a surgical procedure that involves significant pain, which is managed through a multimodal pharmacological approach.The primary objective of the study is to evaluate the quality of hospitalization after cesarean section using the QRo11 questionnaire in patients treated with a postoperative Erector Spinae Plane Block compared to those treated with intrathecal morphine.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult women aged 18-45 years
ASA physical status II-III
Full-term singleton pregnancy scheduled for elective cesarean section under spinal anesthesia
Disqualifiers
ASA ≥ IV
Coagulation disorders
Emergency surgery
Preoperative infection (including infection at the ESPB puncture site)
Trial design
Design model
Parallel
Treatments tested in this trial
Erector spinae plane block
Procedure/SurgeryUltrasound-guided Erector Spinae Plane Block performed at the T9 level with 0,375%, ropivacaine 20 mL administered bilaterally at the end of surgery for postoperative analgesia following cesarean section.
Intrathecal morphine
Procedure/SurgeryIntrathecal administration of 100 mcg of morphine in combination with a local anesthetic was performed at the time of spinal anesthesia for cesarean section.
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: Erector Spinae Plane BlockExperimental treatment 1 intervention
Group B: Intrathecal MorphineITMActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
QoR-11 questionnaire score
Assessment of QoR-11 questionnaire score
Time frame
day 1 after surgerySecondary outcomes
1
Numerical Rating Scale (NRS) pain scores
Assessment of Numerical Rating Scale (NRS) pain scores both at rest and during movement. NRS 0-10. 0 mean a better outcome, 10 mean a worse outcome.
Time frame
4, 6, 8, 12, and 24 hours after cesarean section2
rescue dose
Time to first rescue dose (interval between the block or intrathecal morphine administration and the first request for opioid analgesia).
Time frame
day 1 after surgery3
complications
Assessment of adverse events such as sedation, nausea, and other complications
Time frame
day 1 after surgery4
breastfeeding latch
Time from birth to first breastfeeding latch
Time frame
day 1 after surgerySponsors and contacts
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Source ClinicalTrials.gov