Bilevel Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Analgesia After Cesarean Delivery.

NCT07137208 | Completed

• 1 other identifier: Bilevel ESPB for CS analgesia
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Optimizing analgesia after cesarian delivery is an essential element of enhancing maternal recovery.A multimodal analgesic approach incorporating truncal blocks can provide effective pain relief with minimal side effects for both mother and infant.The posterior TAP block may provide enhanced effect due to possible retrograde spread to the paravertebral space.The ESP block has emerged as a valuable component of multimodal pain management, providing effective postoperative analgesia for various surgeries, including cesarean delivery. We hypothesized that the bilevel ESP block will offer superior analgesic efficacy compared to the TAP block and may be a valuable addition to multimodal analgesic regimens targeting opioid use reduction.

Conditions

Cesarean Section Wound

Outcome Measures

Primary Outcomes (1)

• Total analgesic requirements of fentanyl

  The amount of fentanyl consumption given as a rescue analgesia to patients will be measured all over the 24 hours.

  Up to 24 hours after the procedure

Secondary Outcomes (4)

• the first analgesic request time

  Up to 24 hours after the procedure

• The intensity of postoperative pain

  Up to 24 hours after the procedure

• Patient satisfaction

  Up to 24 hours after the procedure

• Incidence of any adverse effects

  Up to 24 hours after the procedure

Study Arms (2)

Bilevel ESP block group

ACTIVE COMPARATOR

Ultrasound-guided bilevel ESP block will be performed under strict aseptic precautions and patients will be positioned in the right lateral position.

Procedure: ESP block; Drug: Bupivacaine injection

Posterior TAP block group

ACTIVE COMPARATOR

Ultrasound-guided posterior TAP block will be performed under strict aseptic precautions and patients will be positioned the supine position.

Procedure: TAP Block; Drug: Bupivacaine injection

Interventions

ESP block PROCEDURE

In the ESP group, patients will be positioned in the right lateral position. The ultrasound probe will be placed vertically about 3 cm lateral to the spinous process of T9 to visualize the transverse process, trapezius, and erector spinae muscles. A 22-gauge spinal needle will be inserted in-plane in the cranial-to-caudal direction until the needle tip reaches the fascial plane between the erector spinae muscle and transverse process. Following hydrodissection with 2 mL of sterile saline to confirm needle placement, and negative aspiration to rule out intravascular placement, the local anesthetic will be injected. Likewise, the same block procedure will be performed at the T11 level and on both levels on the other side, 10 mL will be injected at each of the four injection sites.

Bilevel ESP block group

TAP Block PROCEDURE

In the TAP group, patients will be positioned in the supine position. A posterior approach will be employed, with the ultrasound probe placed transversely on the anterolateral abdominal wall, midway between the costal margin and iliac crest, posterior to the midaxillary line. This will allow visualization of the external oblique, internal oblique, and transversus abdominis muscles. The probe will then be moved posteriorly to identify the tapering of the transversus abdominis muscle toward the quadratus lumborum. A 22-gauge spinal needle will be inserted in-plane from anterior to posterior. Following hydrodissection with 2 mL of sterile saline to confirm needle placement, and negative aspiration to rule out intravascular placement, the local anesthetic will be injected into the plane between the internal oblique and transversus abdominis muscles. Likewise, the same block procedure will be performed on the other side.

Posterior TAP block group

Bupivacaine injection DRUG

A total of 20 mL of 0.25 bupivacaine will be administered at each side.

Also known as: 0.25 bupivacaine

Bilevel ESP block group; Posterior TAP block group

Eligibility Criteria

• Age: 19 Years - 40 Years
• Gender Eligibility Details: pregnant with singleton full term
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Parturients with full term singleton pregnancy.
• American Society of Anesthesiologists (ASA) physical status II.

You may not qualify if:

• Body mass index (BMI) ≥ 35 kg/m².
• Cerebrovascular, cardiovascular, hepatic, or renal disease.
• Any contraindication to spinal anesthesia, local anesthetic or opioids.
• Pre-existing chronic pain syndrome or history of recent opioid exposure.
• Inability to comprehend or participate in pain scoring system.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, 35511, Egypt

Location

Related Publications (9)

• Kamel AAF, Amin OAI, Ibrahem MAM. Bilateral Ultrasound-Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Postoperative Analgesia after Total Abdominal Hysterectomy. Pain Physician. 2020 Jul;23(4):375-382.

  PMID: 32709172 RESULT

• Eksteen A, Wagner J, Kleyenstuber T, Kamerman P. Comparison of erector spinae plane and transversus abdominis plane block for postoperative analgesia after caesarean delivery under spinal anaesthesia: A randomised controlled trial. Int J Obstet Anesth. 2024 Nov;60:104259. doi: 10.1016/j.ijoa.2024.104259. Epub 2024 Aug 30.

  PMID: 39307664 RESULT

• Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.

  PMID: 33403545 RESULT

• Canakci E, Gultekin A, Cebeci Z, Hanedan B, Kilinc A. The Analgesic Efficacy of Transverse Abdominis Plane Block versus Epidural Block after Caesarean Delivery: Which One Is Effective? TAP Block? Epidural Block? Pain Res Manag. 2018 Oct 17;2018:3562701. doi: 10.1155/2018/3562701. eCollection 2018.

  PMID: 30416635 RESULT

• Silverman M, Zwolinski N, Wang E, Lockwood N, Ancuta M, Jin E, Li J. Regional Analgesia for Cesarean Delivery: A Narrative Review Toward Enhancing Outcomes in Parturients. J Pain Res. 2023 Nov 10;16:3807-3835. doi: 10.2147/JPR.S428332. eCollection 2023.

  PMID: 38026463 RESULT

• Hussain N, Brull R, Thaete L, Fuller S, D'Souza RS, Mankinen-Abdallah Y, Essandoh MK, Weaver TE, Abdallah FW. The analgesic effects of novel fascial plane blocks compared with intrathecal morphine after Caesarean delivery: a systematic review and meta-analysis. Br J Anaesth. 2025 May;134(5):1415-1431. doi: 10.1016/j.bja.2025.01.032. Epub 2025 Mar 11.

  PMID: 40074621 RESULT

• Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.

  PMID: 26827847 RESULT

• Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of peripheral nerve blocks for cesarean delivery analgesia. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100752. doi: 10.1136/rapm-2019-100752. Online ahead of print.

  PMID: 31653797 RESULT

• Sangkum L, Tangjitbampenbun A, Chalacheewa T, Brennan K, Liu H. Peripheral Nerve Blocks for Cesarean Delivery Analgesia: A Narrative Review. Medicina (Kaunas). 2023 Nov 4;59(11):1951. doi: 10.3390/medicina59111951.

  PMID: 38004000 RESULT

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Amany H Eldeeb

  Faculty of Medicine, Mansoura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A single investigator will handle eligibility screening, informed consent, and baseline data collection. An anesthesiology resident, not involved in the study, will administer the spinal anesthesia, record intraoperative data, and prepare the block solution. The patients will be separated from the surgical field and the operators by a large opaque screen. After achieving an upper sensory level of T6 or higher, the primary investigator (who will not participate in anesthesia or postoperative care) will open group allocation envelopes and perform the block after skin closure. All blocks will be done by the same anesthesiologist. Postoperative data will be collected by independent assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia, ICU & pain management; Faculty of Medicine

Model Details: Randomized controlled, single-blind study.

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 22, 2025
• Study Start: October 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: January 15, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)