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

NCT05840406 | Completed

• 1 other identifier: 003-06/22-03/007
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Cesarean section; Wound healing; Nerve block; Cortisol; Immune response

Outcome Measures

Primary Outcomes (4)

• Wound healing

  Wound healing will be assessed 72 hours after cesarean delivery using a standardized REEDA scale. REEDA includes five factors associated with the healing of an incision: redness, edema, ecchymosis, discharge, and approximation of the two edges of the wound, each receiving a score between 0-3, with a higher score indicating a greater level of tissue trauma and less healed wound compared to lower scores.

  72 hours after the surgery

• Measure the stress response (serum cortisol)

  Venous blood samples will be collected at 7 a.m. on the day of surgery and at 7 a.m. on the 3rd postoperative day. Serum cortisol levels will be measured by using electrochemiluminescence immunoassay (ECLIA).

  up to 72 hours

• Measure immune response (neutrophil to lymphocyte ratio)

  The neutrophil to lymphocyte ratio will be calculated as a simple ratio between absolute neutrophil and lymphocyte counts measured in peripheral blood. Venous blood samples will be collected the day before the surgery at the admission and at 7 a.m. on the third postoperative day.

  up to 72 hours

• Measure immune response (platelet to lymphocyte ratio)

  The platelet to lymphocyte ratio will be calculated as a simple ratio between absolute platelet and lymphocyte counts measured in peripheral blood. Venous blood samples will be collected the day before the surgery at the admission and at 7 a.m. on the third postoperative day.

  up to 72 hours

Secondary Outcomes (2)

• Postoperative pain score

  4, 8, 12, 18, 24, and 72 hours after surgery

• Quality of recovery

  24 hours after the surgery

Study Arms (3)

Group SA

ACTIVE COMPARATOR

No TAP block applied.

Drug: Postoperative pain management with acetaminophen; Drug: Postoperative pain management with tramadol; Drug: Postoperative pain management with ketoprofen; Drug: Postoperative pain management with ibuprofen

Group L

EXPERIMENTAL

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml will be administered in the block on each side.

Drug: Postoperative pain management with acetaminophen; Procedure: Bilateral TAP Block with levobupivacaine; Drug: Postoperative pain management with tramadol; Drug: Postoperative pain management with ketoprofen; Drug: Postoperative pain management with ibuprofen

Group D

EXPERIMENTAL

Ultrasound-guided bilateral TAP block (in-plane technique) will be performed in this group. Levobupivacaine 0.25 % 20 ml + dexmedetomidine 0,5 μg/kg will be administered in the block on each side.

Drug: Postoperative pain management with acetaminophen; Procedure: Bilateral TAP Block with levobupivacaine and dexmedetomidine; Drug: Postoperative pain management with tramadol; Drug: Postoperative pain management with ketoprofen; Drug: Postoperative pain management with ibuprofen

Interventions

Postoperative pain management with acetaminophen DRUG

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.

Group D; Group L; Group SA

Bilateral TAP Block with levobupivacaine PROCEDURE

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

Group L

Bilateral TAP Block with levobupivacaine and dexmedetomidine PROCEDURE

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.

Group D

Postoperative pain management with tramadol DRUG

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

Group D; Group L; Group SA

Postoperative pain management with ketoprofen DRUG

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.

Group D; Group L; Group SA

Postoperative pain management with ibuprofen DRUG

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

Group D; Group L; Group SA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Sestre Milosrdnice: lead

Study Sites (1)

University Hospital Center Sestre milosrdnice

Zagreb, 10000, Croatia

Location

Related Publications (13)

• Lavand'homme P. Postoperative cesarean pain: real but is it preventable? Curr Opin Anaesthesiol. 2018 Jun;31(3):262-267. doi: 10.1097/ACO.0000000000000585.

  PMID: 29521684 BACKGROUND

• Ernawati E, Amirah A, Sumartono C, Aditiawarman A. Comparison of Post-Caesarean Section Wound Healing Methods Based on Reeda Scale and Platelet Lymphocyte Ratio. Syst Rev Pharm. 2020;11(7):5. doi:10.31838/srp.2020.7.49

  BACKGROUND

• Rotem R, Erenberg M, Rottenstreich M, Segal D, Yohay Z, Idan I, Yohay D, Weintraub AY. Early prediction of post cesarean section infection using simple hematological biomarkers: A case control study. Eur J Obstet Gynecol Reprod Biol. 2020 Feb;245:84-88. doi: 10.1016/j.ejogrb.2019.12.009. Epub 2019 Dec 23.

  PMID: 31884150 BACKGROUND

• Hughes O, MacQuhae F, Rakosi A, Herskovitz I, Kirsner RS. Stress and wound healing. U: França K, Jafferany M, ur. Stress and skin disorders: Basic and clinical aspects. Cham: Springer; 2017. P. 185-207.

  BACKGROUND

• Childs C, Sandy-Hodgetts K, Broad C, Cooper R, Manresa M, Verdu-Soriano J. Risk, Prevention and Management of Complications After Vaginal and Caesarean Section Birth. J Wound Care. 2020 Nov 1;29(Sup11a):S1-S48. doi: 10.12968/jowc.2020.29.Sup11a.S1. No abstract available.

  PMID: 33170077 BACKGROUND

• Siddiqui MR, Sajid MS, Uncles DR, Cheek L, Baig MK. A meta-analysis on the clinical effectiveness of transversus abdominis plane block. J Clin Anesth. 2011 Feb;23(1):7-14. doi: 10.1016/j.jclinane.2010.05.008.

  PMID: 21296242 BACKGROUND

• Liu R, Qin H, Wang M, Li K, Zhao G. Transversus abdominis plane block with general anesthesia blunts the perioperative stress response in patients undergoing radical gastrectomy. BMC Anesthesiol. 2019 Nov 7;19(1):205. doi: 10.1186/s12871-019-0861-0.

  PMID: 31699052 BACKGROUND

• Varshney A, Prabhu M, Periyadka B, Nanjundegowda DC, Rao A. Transversus abdominis plane (TAP) block with levobupivacaine versus levobupivacaine with dexmedetomidine for postoperative analgesia following cesarean delivery. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):161-164. doi: 10.4103/joacp.JOACP_372_17.

  PMID: 31303702 BACKGROUND

• Sun Q, Liu S, Wu H, Ma H, Liu W, Fang M, Liu K, Pan Z. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block: A Systematic Review and Meta-analysis. Clin J Pain. 2019 Apr;35(4):375-384. doi: 10.1097/AJP.0000000000000671.

  PMID: 30475260 BACKGROUND

• Surhonne N, Hebri C, Kannan S, Duggappa DR, Rs RR, Mapari CG. The effect of anesthetic techniques on neutrophil to lymphocyte ratio in patients undergoing infraumbilical surgeries. Korean J Anesthesiol. 2019 Oct;72(5):458-465. doi: 10.4097/kja.d.19.00022. Epub 2019 May 17.

  PMID: 31096728 BACKGROUND

• Kiriakopoulos N, Grigoriadis S, Maziotis E, Philippou A, Rapani A, Giannelou P, Tsioulou P, Sfakianoudis K, Kontogeorgi A, Bakas P, Mastorakos G, Koutsilieris M, Simopoulou M. Investigating Stress Response during Vaginal Delivery and Elective Cesarean Section through Assessment of Levels of Cortisol, Interleukin 6 (IL-6), Growth Hormone (GH) and Insulin-Like Growth Factor 1 (IGF-1). J Clin Med. 2019 Jul 27;8(8):1112. doi: 10.3390/jcm8081112.

  PMID: 31357604 BACKGROUND

• McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.

  PMID: 18165577 BACKGROUND

• Sultan P, Kamath N, Carvalho B, Bansal P, Elkhateb R, Dougan S, Whittington J, Guo N, El-Sayed Y, Mhyre J, Sharawi N. Evaluation of inpatient postpartum recovery using the Obstetric Quality of Recovery-10 patient-reported outcome measure: a single-center observational study. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100202. doi: 10.1016/j.ajogmf.2020.100202. Epub 2020 Aug 17.

  PMID: 33345919 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Levobupivacaine; Dexmedetomidine; Tramadol; Ketoprofen; Ibuprofen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bupivacaine; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Mirta Ciglar, MD

  University Hospital Center Sestre Milosrdnice

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective single-blind randomized control trial

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: May 3, 2023
• Study Start: September 3, 2024
• Primary Completion: March 17, 2025
• Study Completion: March 20, 2025
• Last Updated: November 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)