At a glance
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Effect of a Transversus Abdominis Plane Block on Operative Wound Healing, Stress, and Immune Response After a Cesarean Delivery
In Brief
A clinical study evaluating Postoperative pain management with acetaminophen, Bilateral TAP Block with levobupivacaine, and 4 other interventions for Postoperative Pain and 2 related conditions. Completed, enrolled 105 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
During the 24 hours postoperatively, participants will receive 1 g acetaminophen intravenously (i.v.) three times a day. On the second and third postoperative days, participants will receive 1g acetaminophen per os three times a day.
Ultrasound-guided bilateral TAP block will be performed, and 20 ml of 0,25 % levobupivacaine will be administered to the participant on each side.
Ultrasound-guided bilateral TAP block will be performed, and 20 ml of 0,25 % levobupivacaine with the addition of 0,5 μg/kg dexmedetomidine will be administered to the participant on each side.
During the 24 hours postoperatively, participants will receive 500 mg tramadol + 500 ml 0,9% NaCl i.v. continuously 30ml/h.
During the 24 hours postoperatively, participants will receive 100 mg ketoprofen + 100 ml of 0,9% NaCl i.v. twice a day. The first dose will be administered in the theatre at the end of the surgical procedure.
On the second and third postoperative days, participants will receive 600 mg ibuprofen per os three times a day.