Patient Perception of Sensory Stimuli During Elective Cesarean Delivery Under Neuraxial Anesthesia (PIONEER): A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,005
- 试验地点
- 1
- 主要终点
- Proportion of participants who request a Pharmacological Intervention in Response to an Intraoperative Sensory Stimulus
研究概览
简要总结
During a cesarean delivery (C-section), most patients are awake and receive spinal or epidural anesthesia to block pain from the lower body. Even when this anesthesia works well, many patients still feel sensations during surgery, such as pulling, pressure, tugging, or, in some cases, pain. In the past, studies have mostly focused on whether patients felt "pain," and have often relied on patients remembering their experience afterward or on the surgical team's judgment of how the patient was doing. These approaches can miss sensations that bother the patient but are not clearly described as pain, and they may not reflect what the patient actually wanted done at the time.
This study takes a different approach. Instead of asking only about pain, the researchers will ask patients, in real time during their C-section, what they are feeling in their own words, and whether they would like the medical team to do something about it (such as giving medication). The main idea is that the patient's own request for help, rather than someone else's opinion about how severe a sensation is, should be what counts as a moment that matters.
The main purpose of the study is to find out how often patients undergoing a planned C-section ask for medication in response to a sensation they feel during surgery. The researchers will ask each patient at six specific points during the operation whether they feel any sensation, how they would describe it, and whether they would like the team to act. Patients will also rate how strong each sensation is and point to where on the body they feel it. All decisions about care will remain entirely with the patient's own medical team; the research team only records what the patient reports and what care is given.
The study is also designed to answer several related questions:
- What words and descriptions do patients naturally use for the sensations they feel during a C-section?
- How often are sensations that patients do not call "painful" still bothersome enough that the patient asks for medication?
- How do patients' feelings and mental health change over the first six months after delivery, including symptoms of post-traumatic stress, depression, and birth-related distress?
- Does a patient's anxiety before surgery affect what they feel during surgery or how likely they are to ask for help?
The main question the study is trying to answer is: How often do patients undergoing a planned cesarean delivery ask for medication because of something they feel during the operation?
The researchers' hypothesis is that this number will be higher than what earlier pain-focused studies have reported. Specifically, they expect that more than 11.5 percent of patients will ask for medication during surgery, which is greater than the rate of pain requiring extra medication found in a similar previous study. If correct, this would suggest that the true number of patients who experience moments during a C-section when they want help has been underestimated by traditional methods that focus only on pain.
This is an observational study. It does not test a new drug or change how anesthesia or surgery is performed. Instead, it carefully observes and records patients' experiences in order to better understand what patients feel during a cesarean delivery, how often they want the team to act, and how these experiences relate to their recovery and emotional well-being afterward. The goal is to use this information to improve the comfort, care, and long-term well-being of patients having a C-section.
详细描述
Study design and setting
This is a multicenter, prospective, longitudinal observational cohort study conducted at tertiary-care obstetric centers. The coordinating center is British Columbia Women's Hospital (Vancouver, Canada), which performs approximately 15 to 20 elective cesarean deliveries under neuraxial anesthesia per week. Additional participating centers are recruited from the academic obstetric anesthesia community through the PIONEER multicenter collaborative and are added as each completes local regulatory approval and site initiation. Every center follows a common protocol with identical intraoperative assessment instruments, identical surgical timepoint definitions, identical eligibility criteria, and an identical longitudinal follow-up schedule, while preserving local institutional standards for anesthetic and surgical care. The study is conducted in compliance with the Declaration of Helsinki and the International Council for Harmonisation Good Clinical Practice guidelines.
The study is strictly observational. The research team does not participate in, direct, or influence any aspect of clinical care. All decisions about anesthesia, surgery, and the management of patient comfort rest entirely with the attending clinical team. The research team documents only what the participant reports and what care the clinical team provides.
Study procedures
Preoperative phase. Eligible patients are identified from the elective surgical schedule and approached on the day of surgery after standard preoperative nursing assessment. Following written informed consent, baseline questionnaires are completed by the participant directly in REDCap on a study device. Demographic and clinical data are collected from the participant and the medical record, including age, height, weight, body mass index, ethnicity, race, primary language, gravidity, gestational age, number of previous cesarean deliveries, surgical indication, comorbidities, psychiatric history and medication history, current medications, and baseline vital signs. Participants receive a structured orientation to the two intraoperative tools (a visual analog scale for sensation intensity and a standardized body diagram for sensation location) and practice using them in the configuration that will be used in the operating room, where the tools are positioned within the participant's field of vision and within reach of the arm bearing the pulse oximeter. Participants are told once, in a standardized manner, that any sensation they report is of interest, that there is no expected answer, and that they may decline to respond at any time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant and 19 years of age or older
- •Single (one) baby at 37 weeks of pregnancy or later
- •Overall health classified as American Society of Anesthesiologists (ASA) Physical Status II or III
- •Scheduled for a planned (elective) cesarean delivery using spinal anesthesia (single-shot spinal or combined spinal-epidural)
- •Able to describe sensations in their own words in one of the study's available languages
- •Willing and able to give written informed consent before any study procedures
- •Willing and able to complete online follow-up questionnaires at 6 weeks, 3 months, and 6 months after delivery
排除标准
- •History of a chronic pain condition (for example, fibromyalgia, chronic pelvic pain, complex regional pain syndrome, or chronic low back pain requiring ongoing treatment)
- •Regular use of opioids, gabapentinoids (gabapentin or pregabalin), or other centrally acting pain medications during the current pregnancy (occasional acetaminophen use is allowed)
- •History of a neurological condition that can affect normal sensation (for example, peripheral neuropathy, multiple sclerosis, or spinal cord injury)
- •Pregnancy with more than one baby (twins or more)
- •Cesarean delivery planned with an anesthesia method other than single-shot spinal or combined spinal-epidural (for example, topping up an existing labor epidural, or general anesthesia)
- •Known major fetal abnormality or an expected newborn complication likely to require immediate admission to the neonatal intensive care unit (NICU)
- •Known allergy or other reason the local anesthetic medications used for spinal anesthesia cannot be given
- •Active substance use disorder
研究组 & 干预措施
Elective cesarean delivery under neuraxial anesthesia
Adults undergoing a planned (elective) cesarean delivery under single-shot spinal or combined spinal-epidural anesthesia at a participating tertiary-care obstetric center. All enrolled participants form a single prospective cohort and undergo the same study assessments: standardized self-report of intraoperative sensory experience at six predefined surgical timepoints (including, at each timepoint, whether a sensation is felt, a verbatim description of the sensation, a request for intervention if any, an intensity rating, and the anatomical location of the sensation), followed by longitudinal psychological assessment from a preoperative baseline through 6 months postpartum. Participants are not assigned to any intervention or exposure by the investigators; all anesthetic and surgical care is provided by the clinical team according to institutional standards.
干预措施: Patient-initiated request for pharmacological intervention during cesarean delivery (Other)
结局指标
主要结局
Proportion of participants who request a Pharmacological Intervention in Response to an Intraoperative Sensory Stimulus
时间窗: Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test (immediately before skin incision) through skin closure during the cesarean delivery (typically up to approximately 90 minutes)
At each of six predefined surgical timepoints (surgical sharp-stimulus test before skin incision, skin incision, uterine incision, end of uterine closure, end of fascia closure, and skin closure), participants who report a sensation are asked: "Is there anything you would like us to do to address the sensation, like giving you medication or some other action?" A participant meets the outcome if, at one or more timepoints, the request includes medication (alone or together with some other action). Requests for some other action only, and timepoints with no affirmative response, are counted as non-events. The measure is the proportion (percentage) of participants with at least one qualifying request: the numerator is participants requesting a pharmacological intervention; the denominator is all analyzable participants. Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model.
Incidence of intraoperative sensory stimuli perceived as unacceptable
时间窗: From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.
Proportion of participants who report experiencing any intraoperative sensory stimulus that they subjectively self-report as unacceptable.
次要结局
- Thematic Categories of Patient-Reported Descriptions of Intraoperative Sensory Experiences(Intraoperative; verbatim descriptions collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins))
- Incidence of Each Type of Patient-Reported Sensory Experience at Each Surgical Timepoint(Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins))
- Intensity of Patient-Reported Intraoperative Sensation Measured on a 100-mm Visual Analog Scale at Each Surgical Timepoint(Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins))
- Edinburgh Postnatal Depression Scale (EPDS) Total Score at Each Assessment Timepoint(Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days))
- Anatomical Distribution of Patient-Reported Intraoperative Sensations Recorded on a Standardized Body Diagram at Each Surgical Timepoint(Intraoperative; assessed at each of the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins))
- Temporal Pattern of Patient-Reported Intraoperative Sensations Across the Six Surgical Timepoints(Intraoperative; assessed across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins))
- Proportion of Non-Pain Sensory Stimuli That Prompted a Patient Request for Pharmacological Intervention(Intraoperative; sensory events and associated requests collected across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins))
- Concordance Between Patient-Initiated Requests for Pharmacological Intervention and Receipt of Supplemental Intraoperative Analgesia(Intraoperative; requests and analgesia administration recorded across the six surgical timepoints from the surgical sharp-stimulus test through skin closure during the cesarean delivery (up to approximately 90 mins))
- PTSD Checklist for DSM-5 (PCL-5) Total Score at Each Assessment Timepoint(Preoperative baseline (day of surgery), 24 to 48 hours postpartum, and 6 weeks, 3 months, and 6 months postpartum (up to a maximum of 183 days))
- Peritraumatic Distress Inventory (PDI) Total Score at 24 to 48 Hours and 6 Weeks Postpartum(24 to 48 hours postpartum and 6 weeks postpartum (up to a maximum of 42 days))
- Proportion of Participants Exceeding Validated Clinical Thresholds on the PCL-5, EPDS, and PDI at Each Postpartum Assessment Timepoint(PCL-5 and EPDS: 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum. (up to a maximum of 183 days) PDI: 24 to 48 hours and 6 weeks postpartum (up to a maximum of 42 days).)
- Association Between Patient-Initiated Requests for Pharmacological Intervention and Exceeding Clinical Thresholds on the PCL-5, EPDS, and PDI(Psychological thresholds assessed at 24 to 48 hours, 6 weeks, 3 months, and 6 months postpartum (PDI at 24 to 48 hours and 6 weeks only), in relation to the intraoperative primary outcome (up to a maximum of 183 days))
- Preoperative Anxiety (STAI-6) and Its Association With Intraoperative Sensory Outcomes and Patient-Initiated Treatment Requests(STAI-6 measured at preoperative baseline (day of surgery); intraoperative sensory outcomes assessed across the six surgical timepoints during the cesarean delivery (up to a maximum of 1 day))
- Proportion of Participants Who Indicated They Would Have Preferred General Anesthesia for Any Part of the Surgery(Assessed once at the conclusion of surgery (end of the cesarean delivery) (up to a maximum 90 mins))
- Total Supplemental Intraoperative Intravenous Analgesia Administered, by Drug Type and Cumulative Dose(Intraoperative; from neuraxial placement through the end of the cesarean delivery (up to a maximum of 90 mins))
- In-Hospital Opioid Consumption From End of Surgery to Discharge, in Oral Morphine Milligram Equivalents (MME)(From end of surgery to hospital discharge (up to a maximum of 7 days))
- Length of Hospital Stay From End of Surgery to Discharge(From end of surgery to official hospital discharge (up to a maximum of 7 days))
- Qualitative description of unacceptable sensory stimuli(From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.)
- Severity of intraoperative sensory stimuli(From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.)
- Total intraoperative supplemental IV analgesia received(From date of enrollment until the date of cesarean delivery completed, assessed up to 1day.)
- PTSD symptoms over time(From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.)
- Depressive symptoms over time(From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.)
- Peritraumatic distress over time(From date of enrollment until the date of follow-up completion, assessed up to 6 months post-partum.)
- Postoperative pain intensity (NRS)(From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum.)
- In-hospital opioid requirement (MME)(From date of enrollment until the date of discharge from hospital, assessed up to 3 weeks post-partum.)
研究者
Juliana Barrera
Clinical Asisstant Professor
University of British Columbia