Decision Making , Cesarean SectionNCT07476482
The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delivery Under Spinal Anesthesia
A study testing 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. in people with Decision Making , Cesarean Section, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Decision Making , Cesarean Section
- What is being tested?
- 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.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Decision Making , Cesarean Section
- Being tested
- 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)
- Keywords
- Shared Decision-Making, Cesarean Delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.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: administer the chosen medication prior to skin incision. Reactive: administer rescue analgesia only if pain is reported.
Control Group (Standard Care)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group (Standard Care) | Placebo comparator | 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. Receives: Other: Control Group (Standard Care) |
| SDM Group (Structured Intervention) | Active comparator | 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.
Proactive: administer the chosen medication prior to skin incision. Reactive: administer rescue analgesia only if pain is reported. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: any intraoperative time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Decision Making , Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476482
- Sponsor's protocol ID
- Decision Making in CS
- Status last verified
- Jan 2026
- First submitted
- 1 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: through clinical trials
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.
PubMed 22618581
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Shared Decision-Making Intervention on Intraoperative Patient Experience During Elective Cesarean Delivery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07476482
- Acronym / sponsor ID
- Decision Making in CS
- Conditions
- Decision Making , Cesarean Section
- Keywords
- Shared Decision-Making, Cesarean Delivery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group (Standard Care) | Placebo comparator | 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. |
| SDM Group (Structured Intervention) | Active comparator | 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.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. Proactive: administer the chosen medication prior to skin incision. Reactive: administer rescue analgesia only if pain is reported. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | SDM Group (Structured Intervention) |
| 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. | Other | Control Group (Standard Care) |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Results publication: PubMed 22618581Elwyn 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.
- Individual participant dataSharing planned: Yes. through clinical trials
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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. in people with Decision Making , Cesarean Section, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07476482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.