Sensory Stimuli During Cesarean Delivery
ConditionIntraoperative Pain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age19+
SponsorUniversity of British Columbia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial population
Participants are drawn from patients scheduled for planned cesarean delivery at participating tertiary-care obstetric centers in North America. The coordinating center is British Columbia Women's Hospital (Vancouver, Canada), a tertiary-care obstetric referral center performing approximately 15 to 20 elective cesarean deliveries under neuraxial anesthesia per week; additional participating centers include Western University (London, Canada) and the University of Arkansas for Medical Sciences (Little Rock, USA). Potential participants are identified prospectively from each center's daily elective surgical schedule and approached on the day of surgery in the preoperative area, after standard preoperative nursing assessment and once the nurse confirms the patient is amenable to being approached. The sample reflects the obstetric populations served by these academic referral centers across a range of North American obstetric anesthesia practice.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Patient-initiated request for pharmacological intervention during cesarean delivery
Other interventionThe exposure of interest is the participant's own request, made during cesarean delivery, for the clinical team to provide a pharmacological intervention in response to an intraoperative sensory stimulus. At each of six predefined surgical timepoints, participants who report a sensation are asked whether they would like the team to act and, if so, whether they are requesting medication, some other action, or both. A request that includes medication constitutes the exposure. This is an observed, patient-initiated event; investigators do not assign or administer it, and all clinical management remains at the discretion of the treating team. This exposure is linked to the single study cohort (Elective cesarean delivery under neuraxial anesthesia).
Treatment groups
1,005 Participants
are divided into 1 treatment groupGroup A: Elective cesarean delivery under neuraxial anesthesia1 intervention
Trial outcomes
Primary outcomes
1
Proportion of participants who request a Pharmacological Intervention in Response to an Intraoperative Sensory Stimulus
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.
Time frame
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)Secondary outcomes
1
Thematic Categories of Patient-Reported Descriptions of Intraoperative Sensory Experiences
Verbatim responses to the standardized open-ended prompt "How would you describe the sensation you are feeling?", administered at each of six predefined surgical timepoints to participants who report a sensation, are analyzed by inductive qualitative content analysis. Sensory categories are derived inductively from participants' own descriptions rather than predefined classifications. Two independent investigators develop and refine a codebook through iterative open coding; inter-rater reliability is assessed on a random subset using Cohen's kappa (prespecified threshold 0.70) before full coding. The outcome is the set of thematic categories of intraoperative sensory experience, reported with the frequency of each category and its distribution across the six surgical timepoints. Reported per the Standards for Reporting Qualitative Research (SRQR).
Time frame
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)2
Incidence of Each Type of Patient-Reported Sensory Experience at Each Surgical Timepoint
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 report whether they feel any sensation. Sensory categories are derived inductively from participants' own verbatim descriptions rather than predefined classifications (see the qualitative content analysis). For each surgical timepoint, the incidence of any reported sensation and of each inductively derived sensory category is calculated as the proportion (percentage) of participants reporting that sensation. Site-specific proportions are estimated with 95% Clopper-Pearson exact confidence intervals and pooled across participating centers using a DerSimonian-Laird random-effects model on the logit scale, with back-transformation to the proportion scale.
Time frame
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)3
Intensity of Patient-Reported Intraoperative Sensation Measured on a 100-mm Visual Analog Scale at Each Surgical Timepoint
Participants who report a sensation at a given surgical timepoint rate its intensity on a 100-mm horizontal Visual Analog Scale (VAS), anchored at the left end by "no sensation" (0 mm) and at the right end by "worst imaginable sensation" (100 mm); higher scores indicate greater intensity. The score is the distance in millimeters from the left anchor to the participant's mark (continuous, range 0 to 100 mm). Intensity is assessed 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). For each timepoint, VAS scores are summarized within each participating center as medians with interquartile ranges and pooled across centers by random-effects meta-analysis.
Time frame
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)4
Anatomical Distribution of Patient-Reported Intraoperative Sensations Recorded on a Standardized Body Diagram at Each Surgical Timepoint
Participants who report a sensation at a given surgical timepoint indicate its location on a standardized body diagram. Each marked location is coded to a set of predefined anatomical regions specified a priori in the body-diagram coding key. 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), the outcome is the proportion (percentage) of participants reporting sensation in each anatomical region. Site-specific proportions are pooled across participating centers using a DerSimonian-Laird random-effects model on the logit scale, with back-transformation to the proportion scale. Distributions are additionally cross-tabulated by sensory category and by surgical timepoint to describe spatial and spatiotemporal patterns.
Time frame
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of British Columbia
Lead sponsor
Western University, Canada
Collaborator
University of Arkansas
Collaborator
Source ClinicalTrials.gov