The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delivery Under Spinal Anesthesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision. Reactive Plan: no prophylactic medication; rescue IV fentanyl 50 mcg administered only if NRS ≥4., Control Group (Standard Care).
- Who it may be relevant to
- Registry conditions: Decision Making , Cesarean Section. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Caesarean delivery (CD) is a common surgical procedure performed when vaginal delivery poses risks to the mother or fetus, with global rates projected to reach 28.5% by 2030. Neuraxial anesthesia is the preferred technique due to its safety advantages over general anesthesia, which is associated with increased risks such as impaired oxygenation, aspiration, and higher incidence of postpartum depression. Although spinal anesthesia is widely used, it may be complicated by intraoperative pain during cesarean delivery (PDCD), attributed to visceral traction despite adequate sensory block . PDCD is associated with adverse psychological outcomes including anxiety, postpartum depression, and post-traumatic stress disorder , and is the leading cause of obstetric anesthesia-related medicolegal claims in the United Kingdom . Reported incidence rates vary widely, from 2.1% to 36%, reflecting under-recognition and misinterpretation by clinicians who may mistake pain for anxiety . Shared decision-making (SDM) is a patient-centered approach that incorporates patient preferences into perioperative planning and has been shown to improve outcomes in various surgical settings , yet its impact on intraoperative experience during cesarean delivery remains unexplored.
Detailed description
All participants will receive spinal anesthesia in the sitting position at either the L3-L4 or L4-L5 interspace using 0.5% hyperbaric bupivacaine (dose adjusted by patient height) combined with fentanyl 15 mcg. Surgery will commence only after confirmation of a bilateral sensory block to at least the T5 dermatome and motor block. Standard monitoring will be applied continuously throughout the procedure, including ECG, heart rate, noninvasive blood pressure, and pulse oximetry. A preload of 500 mL lactated Ringer's solution will be administered. Intraoperative hypotension, bradycardia, nausea, and respiratory depression will be treated according to institutional protocols. Postoperative pain will be managed using paracetamol and ketorolac, with intravenous morphine administered as rescue analgesia for NRS ≥4.
Intervention Protocol Control Group (Standard Care) Patients will receive standard preoperative counseling delivered by the anesthesiologist using the institutional script. No structured shared decision-making process or documented preference for intraoperative analgesic management will be included.
SDM Group (Structured Intervention)
Patients randomized to the SDM group will participate in a structured 10-15 minute shared decision-making session, based on the Elwyn three-step model(8) (choice talk, option talk, decision talk), supported by an Arabic Option Grid™. Patients will be presented with two intraoperative comfort management options:
Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision.
Reactive Plan: no prophylactic medication; rescue IV fentanyl 50 mcg administered only if NRS ≥4.
The patient's preference will be documented, sealed in an envelope, and handed to the blinded attending anesthesiologist.
Implementation
After confirming adequate spinal block (sensory level to T6), the attending anesthesiologist will open the envelope and implement the assigned plan:
Proactive: administer the chosen medication prior to skin incision. Reactive: administer rescue analgesia only if pain is reported. Pain will be assessed at four predefined intraoperative time points: skin incision, uterine incision, delivery, and peritoneal closure. Continuous communication will be maintained, and any request for analgesia or conversion to general anesthesia will be recorded.
Interventions
- Other Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision. Reactive Plan: no prophylactic medication; rescue IV fentanyl 50 mcg administered only if NRS ≥4.
Proactive Plan: prophylactic IV ketamine 0.2 mg/kg or IV midazolam 1 mg given prior to incision. Reactive Plan: no prophylactic medication; rescue IV fentanyl 50 mcg administered only if NRS ≥4. Proactive: administer the chosen medication prior to skin incision. Reactive: administer rescue analgesia only if pain is reported. - Other Control Group (Standard Care)
Patients will receive standard preoperative counseling delivered by the anesthesiologist using the institutional script. No structured shared decision-making process or documented preference for intraoperative analgesic management will be included.
Primary outcome measures
- The primary outcome will be the incidence and severity of pain during cesarean delivery, defined as an NRS score ≥4 at any intraoperative time point. [Time frame: any intraoperative time point.]
Eligibility criteria
Inclusion criteria
- pregnant women aged 18 years or older, with a singleton pregnancy
- scheduled for elective cesarean delivery under spinal anesthesia
- classified as ASA physical status I or II, and fluent in Arabic.
Exclusion criteria
- refusal to participate; contraindications to spinal anesthesia (such as coagulopathy, infection at the injection site, or severe hypovolemia)
- emergency cesarean procedures
- cognitive impairment
- history of chronic pain disorders
- regular preoperative analgesic use
- conversion to general anesthesia.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
Egypt · 1 center
- medical research institute , Alexandrria university — Alexandria
Publications
- Elwyn G, Frosch D, Thomson R, Joseph-Williams N, Lloyd A, Kinnersley P, Cording E, Tomson D, Dodd C, Rollnick S, Edwards A, Barry M. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012 Oct;27(10):1361-7. doi: 10.1007/s11606-012-2077-6. Epub 2012 May 23. PMID 22618581
Identifiers
NCT: NCT07476482 · Decision Making in CS