Sensory Stimuli During Cesarean Delivery

Condition(s) studied

Investigational drug(s) / intervention(s)

Patient-initiated request for pharmacological intervention during cesarean delivery: The 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).

Study summary

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

Primary outcome measure(s)

• Proportion of participants who request a Pharmacological Intervention in Response to an Intraoperative Sensory Stimulus — 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.

Trial sites (1)

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