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The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delivery Under Spinal Anesthesia

The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delivery Under Spinal Anesthesia

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07476482
Enrollment
80
Registered
2026-03-17
Start date
2026-04-01
Completion date
2027-10-01
Last updated
2026-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decision Making , Cesarean Section

Keywords

Shared Decision-Making, Cesarean Delivery

Brief summary

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

OTHERProactive 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.

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.

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. pregnant women aged 18 years or older, with a singleton pregnancy 2. scheduled for elective cesarean delivery under spinal anesthesia 3. classified as ASA physical status I or II, and fluent in Arabic.

Exclusion criteria

1. refusal to participate; contraindications to spinal anesthesia (such as coagulopathy, infection at the injection site, or severe hypovolemia) 2. emergency cesarean procedures 3. cognitive impairment 4. history of chronic pain disorders 5. regular preoperative analgesic use 6. conversion to general anesthesia.

Design outcomes

Primary

MeasureTime frameDescription
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.any intraoperative time point.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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026