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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.
• Другое 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.

Первичные конечные точки

• 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. [Срок оценки: any intraoperative time point.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

Египет · 1 центр

• medical research institute , Alexandrria university — Alexandria

Публикации

• 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

Идентификаторы

NCT: NCT07476482 · Decision Making in CS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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