Effect of a Transversus Abdominis Plane Block on Operative Wound Healing, Stress, and Immune Response After a Cesarean Delivery

003-06/22-03/007

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.

2024-04-01

2025-04-01

2025-04-01

Not yet recruiting

120

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective single-blind randomized control trial', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': "Participants will be randomly allocated to either a group SA receiving the standard postoperative analgesia or groups receiving the TAP block with levobupivacaine (group L) or levobupivacaine with the addition of dexmedetomidine (group D). The allocation sequence will be generated by a random number table. After signing an informed consent, participants and an anesthesiologist performing the TAP block will be informed about patients' group allocation. An independent observer, who will not know which group the participant belongs to, will assess wound healing using the standardized REEDA scale 72 hours after the cesarean delivery. The same independent observer will assess every participant at 4, 8, 12, 18, 24, and 72 hours after surgery for pain by using the pain numerical rating scale.", 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2023-05-03