Effect of a Transversus Abdominis Plane Block on Wound Healing, Stress, and Immune Response After… (NCT05840406) | Clinical Trial Compass
CompletedNot Applicable
Effect of a Transversus Abdominis Plane Block on Wound Healing, Stress, and Immune Response After a Cesarean Delivery
Croatia105 participantsStarted 2024-09-03
Plain-language summary
The primary purpose of this study is to determine whether the addition of a TAP block to standard analgesia after the cesarean delivery will impact postoperative wound healing and attenuate postoperative stress and immune response.
Random allocation of participants in 3 groups: group SA (standard analgesia), group L (TAP block with levobupivacaine), and group D (TAP block with levobupivacaine + dexmedetomidine). All participants will undergo elective cesarean section through Pfannestiel incision under spinal anesthesia. They will receive standard postoperative pain management with acetaminophen, nonsteroidal anti-inflammatory drugs, and tramadol. Groups L and D will additionally receive bilateral ultrasound-guided TAP block with 20 ml 0,25% levobupivacaine or with 20 ml 0,25% levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine. TAP block will be performed in the theatre immediately after the cesarean delivery.
Venous blood samples will be collected before the surgery and on the third postoperative day. Complete blood count and serum cortisol levels will be measured. REEDA scale will be used for assessing wound healing.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients scheduled for the elective cesarean section through Pfannenstiel incision under spinal anesthesia
* Age \>18
* American Society of Anesthesiologists (ASA) physical status II
* Body mass index \< 40 mg/kg²
* \>35 gestational weeks
Exclusion Criteria:
* participant's refusal to participate in the study
* ASA physical status \>II
* emergency cesarean section
* twin or triplets pregnancy
* history of allergy to the local anesthetic or any other drug used in this study (dexmedetomidine, acetaminophen, tramadol, nonsteroidal anti-inflammatory drugs)
* contraindications for spinal anesthesia or TAP block
Drop out from the study:
* the change in anesthetic technique from spinal to the general anesthesia
* the need for the blood transfusion
* acute mastitis, puerperal endometritis, and/or wound infection developed in the first 72 hours postoperatively
* failed TAP block
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Wound healing
Timeframe: 72 hours after the surgery
2
Measure the stress response (serum cortisol)
Timeframe: up to 72 hours
3
Measure immune response (neutrophil to lymphocyte ratio)
Timeframe: up to 72 hours
4
Measure immune response (platelet to lymphocyte ratio)