NCT07582640

Brief Summary

This study is a prospective randomized controlled trial designed to compare the effectiveness of the erector spinae plane (ESP) block versus the transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing cesarean section under spinal anesthesia. Sixty patients will be randomly allocated into two equal groups to receive either ESP or TAP block after surgery. The primary outcome of the study is the assessment of postoperative pain using the Numeric Rating Scale (NRS) over the first 24 hours. Secondary outcomes include total morphine consumption, time to first request for rescue analgesia, patient satisfaction, incidence of complications, and hemodynamic stability. All patients will receive standardized spinal anesthesia followed by the assigned block using a combination of bupivacaine and lidocaine under ultrasound guidance. Postoperatively, a multimodal analgesic regimen will be applied, including regular paracetamol and rescue analgesia with ketorolac or morphine based on pain scores. The rationale of the study is based on the limitation of the TAP block in providing only somatic analgesia, whereas the ESP block may offer both somatic and visceral pain control due to its wider spread. Therefore, the study aims to determine whether ESP block provides superior postoperative analgesia and reduces opioid requirements compared to TAP block after cesarean delivery.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
9mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress16%
Apr 2026Mar 2027

Study Start

First participant enrolled

April 1, 2026

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

April 30, 2026

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Expected
Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

April 30, 2026

Last Update Submit

May 11, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain scores assessment using the Numeric Rating Scale (NRS).

    Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only. Pain scores will be evaluated both at rest and during movement.Patients will be informed about Numerical Rating Scale (NRS) and asked to circle the number between 0 and 10, Zero means no pain and ten means the worst pain\].

    Postoperative pain scores will be assessed using the Numeric Rating Scale (NRS) at 2, 4, 6, 12 and 24 hours only.

Secondary Outcomes (4)

  • Total morphine consumption

    the first 24 hours postoperatively.

  • Time to first request for rescue analgesia.

    during the first 24 postoperative hours.

  • Patient satisfaction scores

    at 24 hours.

  • Incidence of block-related complications

    first 24 hours postoperatively.

Study Arms (2)

ESPB group

ACTIVE COMPARATOR

patients included in this group will receive the erector spinae plane block.

Procedure: Erector Spinae Plane Block For Postoperative Analgesia In Cesarean Section

TAP group

ACTIVE COMPARATOR

patients included in this group will receive the transversus abdominis plane block.

Procedure: Transversus Abdominis Plane Block For Postoperative Analgesia In Cesarean Section

Interventions

For the ESP block, patients will be placed in the right lateral decubitus position, and the T9 transverse process will be identified using a high-frequency linear ultrasound probe positioned 2-3 cm lateral to the midline in a parasagittal orientation. After skin sterilization, a 21-gauge echogenic block needle will be advanced in-plane cranio-caudally until contact with the transverse process is achieved. Hydrodissection with sterile saline will be performed to confirm correct fascial plane placement beneath the erector spinae muscle. A total of 20 mL local anesthetic mixture will be administered on each side, consisting of 10 mL bupivacaine 0.25%- and 10-mL lidocaine 0.5%, ensuring that the maximum safe dose is not exceeded. Correct spread will be confirmed under ultrasound by observing separation of the fascial layers.

ESPB group

For the TAP block, patients will be placed supine, and the posterior approach will be used with the probe placed midway between the subcostal margin and the iliac crest in the anterior axillary line. The fascial plane between the internal oblique and transversus abdominis muscles will be visualized until it tapers toward the quadratus lumborum. A 21-gauge echogenic needle will be introduced in-plane from anterior to posterior, and hydrodissection with sterile saline will be performed to confirm the correct plane. A total of 20 mL local anesthetic mixture will be administered per side, composed of 10 mL bupivacaine 0.25%- and 10-mL lidocaine 0.5%, with care taken to remain within safe dosage limits.

TAP group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age from 18 to 40 years old.
  • Pregnant women.
  • Scheduled for lower-segment cesarean section.
  • American Society of Anesthesiologists (ASA) physical status I-II.
  • Singleton pregnancy at ≥37 weeks' gestation.

You may not qualify if:

  • Contraindications to regional blocks or local anesthetics.
  • History of chronic analgesic use or opioid dependency.
  • Coagulopathy or anticoagulant therapy.
  • Local infection at the injection site.
  • Allergy to study medications.
  • Patient refusal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag Faculty of Medicine

Sohag, Egypt

Location

MeSH Terms

Interventions

Cesarean Section

Intervention Hierarchy (Ancestors)

Delivery, ObstetricObstetric Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Mohamed ali Elyamany, resident

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of Anesthesia, Surgical Intensive Care and Pain Management Faculty of Medicine, Sohag University

Study Record Dates

First Submitted

April 30, 2026

First Posted

May 13, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations