Efficacy and Safety of Intrathecal Morphine for Postoperative Pain Management Following Planned Caesarean Section
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAnne Juul Wikkelsø
About this trial
The goal of this clinical trial is to learn if morphine added to the spinal anaesthesia can improve postoperative pain treatment for patients undergoing caesarean section, without increasing the risk of serious adverse events in mother and baby.
The main questions it aims to answer are:
* Is the treatment effective in preventing postoperative pain? * Is the treatment safe for both mother and baby?
Participants will be given a normal spinal anaesthesia with addition of either morphine or sodium chloride (inactive substance). All participants will receive standard postoperative pain treatment, including morphine tablets as needed. Researchers will collect data from the electronic medical record and ask the participants to fill out questionnaires about pain levels and possible side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years
Singleton pregnancy
Scheduled for planned caesarean section performed under spinal anaesthesia
Written informed consent
Disqualifiers
Allergy to or contraindications towards trial medication
Patients planned for postoperative epidural due to expected difficult postoperative pain management
Patients planned for combined spinal-epidural as primary anaesthesia
Inability to understand and read Danish
Trial design
Design model
Parallel
Treatments tested in this trial
Intrathecal Morphine
Drug80 μg preservative-free morphine (0.2 ml) added to a single-shot spinal anaesthesia consisting of 11.5 mg hyperbaric bupivacaine and 10 μg fentanyl
Placebo (Sodium Chloride Injection, 0.9%)
Drug0.2 ml of isotonic sodium chloride added to a single-shot spinal anaesthesia consisting of 11.5 mg hyperbaric bupivacaine and 10 μg fentanyl.
Treatment groups
1,312 Participants
are divided into 2 treatment groupsGroup A: Intrathecal morphineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Level of pain when mobilising from supine to sitting position within 24 hours
Longitudinal measurements of NRS (0-10) at 6, 12, 18 and 24 hours with most focus on the 24-hour pain level
Time frame
6, 12, 18 and 24 hours following spinal anaesthesia2
Maternal and neonatal serious adverse events
Binary composite outcome: 1. Death of either participant or neonate within 7 days 2. Participants with clinically significant respiratory depression within 24 hours, defined as respiratory depression documented in the electronic medical record, e.g. need for airway management or pharmacological intervention (subjective assessment by treating clinician, validated by 2 investigators) 3. Neonates needing admission to neonatal intensive care unit within 48 hours 4. Hospitalisation of either participant or neonate within 7 days after discharge 5. Participants with severe vomiting or nausea within 24 hours, defined as ≥5 points on the 'Simplified postoperative nausea and vomiting impact scale'63 at any time point (6, 12, 18 and 24 hours)
Time frame
Within 7 days from dischargeSecondary outcomes
1
Opioid consumption within 24 hours
Mg oral morphine equivalents
Time frame
Within 24 hours following spinal anaesthesia2
Morphine associated adverse effects within 24 hours
Binary composite outcome: participants experiencing either: 1. Vomiting (patient reported, yes/no) 2. Nausea 3. Dizziness 4. Pruritus Nausea, dizziness, and pruritus is assessed as "none", "little", "moderate", or "severe" with patients reporting "moderate" or "severe" categorised as having a positive outcome 5. Urinary retention, defined as need for re-catheterisation within 24 hours
Time frame
Within 24 hours following spinal anaesthesia3
Obstetric quality of recovery score at 24 hours
Obs-QoR-10 (0-100)
Time frame
Within 24 hours following spinal anaesthesia4
Participants satisfaction with postoperative pain-treatment during the first 24 hours
NRS 0-10
Time frame
Within 24 hours following spinal anaesthesiaOther outcomes
1
Serious adverse events, pain at 24 hours and opioid consumption, compared using Win Ratio
A composite outcome analysed using Win Ratio, consisting of 1. Maternal and neonatal serious adverse events (as defined in the primary outcome) 2. Level of pain when mobilising from supine to sitting position at 24 hours (NRS 0-10) 3. Opioid consumption within 24 hours (mg oral morphine equivalents)
Time frame
Within 7 days from discharge2
Overall severity of pruritus within 24 hours
NRS 0-10
Time frame
Within 24 hours following spinal anaesthesia3
Pharmacological treatment for opioid-related adverse effects within 24 hours
Dexametasone, dosage (mg) 5-HT3 receptor antagonists, type, dosage (mg) Dopamine receptor antagonists, type, dosage (mg) Droperidol, dosage (mg) Antihistamines, type, dosage (mg) Pethidine, dosage (mg) Naloxone, dosage (mg) Clonidine, dosage (mg)
Time frame
Within 24 hours following spinal anaesthesia4
Ability to mobilise independently
Proportion of participants able to mobilise independently at 6, 12, 18 and 24 hours
Time frame
6, 12, 18 and 24 hours following spinal anaesthesiaSponsors and contacts
Click on the lead sponsor to view all of their trials.
Anne Juul Wikkelsø
Lead sponsor
Zealand University Hospital
Sponsor institution
Source ClinicalTrials.gov