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

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.

Conditions

• Postoperative Pain
• Cesarean Section
• Wound Heal

Interventions

DRUG

Postoperative pain management with acetaminophen

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.

PROCEDURE

Bilateral TAP Block with levobupivacaine

Ultrasound-guided bilateral TAP block will be performed, and 20 ml of 0,25 % levobupivacaine will be administered to the participant on each side.

PROCEDURE

Bilateral TAP Block with levobupivacaine and dexmedetomidine

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.

DRUG

Postoperative pain management with tramadol

During the 24 hours postoperatively, participants will receive 500 mg tramadol + 500 ml 0,9% NaCl i.v. continuously 30ml/h.

DRUG

Postoperative pain management with ketoprofen

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.

DRUG

Postoperative pain management with ibuprofen

On the second and third postoperative days, participants will receive 600 mg ibuprofen per os three times a day.

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice

  lead OTHER

Principal Investigators

• Mirta Ciglar, MD · University Hospital Center Sestre Milosrdnice

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-03

Primary Completion

2025-03-17

Completion

2025-03-20

Countries

• Croatia

Study Locations