Evaluating the Intraoperative Analgesic Effect of Ultrasound Guided Erector Spinae Plane Block in Parturient Undergoing Elective Cesarean Section for Placenta Accreta Under General Anesthesia.

NCT07748741 | Completed

• 1 other identifier: MD-463-2024
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Due to the significant risk of massive bleeding complicated by profound hypotension and coagulopathy and a high likelihood of hysterectomy during caesarean delivery, general anesthesia is generally regarded as the anesthetic of choice for patients with placenta accreta. The advantage of a planned general anesthetic is the ability to secure the airway in a controlled setting, before the onset of hemodynamic instability, airway edema or coagulopathy. A multidisciplinary approach may improve patient outcomes. However, it is necessary to maintain a good depth of anesthesia and sufficient analgesia and to consider the impact of anesthesia drugs on the fetus. Since all opioids, particularly those with high lipid solubility (e.g., remifentanil, fentanyl, and sufentanil), readily pass through the placenta to the fetus. Consequently, opioid administration is usually avoided until after delivery to reduce the risk of neonatal depression. The latest publications have reported that the erector spinae plane block is one of the components of multimodal analgesia techniques for pain management after different surgical procedures, including cesarean delivery.

Conditions

ESPB; C-section; General Anesthesia; Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• Total intraoperative fentanyl consumption

  total dose of fentanyl consumed intraoperative

  the whole procedure

Secondary Outcomes (2)

• The time to first request of rescue analgesia

  24 hours

• Visual analog scale (VAS) at 2 h, 6 h, 12 h, and 24 h after operation

  24 hours

Study Arms (2)

Erector Spinae block .

ACTIVE COMPARATOR

bilateral ESPB with general anesthesia. block will be performed under ultrasound guidance 30 minutes before induction of general anesthesia . After standard disinfection of skin and subcutaneous infiltration of 3 mL of 2% lidocaine, a 22G blunt needle will be introduced from the outside towards the transverse process (T9) using the in-plane method until the needle tip crosses all the muscles. Subsequently, 20 ml of 0.25% Bupivacaine will be injected between the transverse process and the deep surface of the erector spinae on each side. thus the expected dermatomal block would be from T5 to L1. Testing for loss of tactile sensation and discrimination in the expected dermatome will be done 20 min after the injection of drugs. If no loss of sensation was attained within 30 min this will be considered an unsuccessful block and the parturient will be excluded from the study and managed according to the theater protocol.

Procedure: ultra sound guided Erector spinae plane block

general anesthesia

ACTIVE COMPARATOR

general anesthesia with opioids. Patients in this group will be given 1mic/kg fentanyl diluted to 10 ml by IV injection by the attending anesthetist after delivery of the fetus. General anesthesia will be induced in both groups after adequate preoxygenation using propofol 2.5 mg/kg, rocuronium 1 mg/kg. After securing the endotracheal tube (6.5mm), anesthesia will be maintained using 1 MAC isoflurane, timed rocuronium and volume-controlled ventilation 6-8ml/kg to obtain normocarbia.

Procedure: ultra sound guided Erector spinae plane block

Interventions

ultra sound guided Erector spinae plane block PROCEDURE

preoperative ESPB sonar guided in c-section with placenta accreta

Also known as: general anesthesia

Erector Spinae block .; general anesthesia

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists physical status II.
• Female patients aged 18 to 40 years' old.
• BMI less than 40.
• Diagnosed placenta accreta

You may not qualify if:

• Patient's unwillingness to participate in the study.
• Contraindication to receive regional anesthesia.
• Patients with anticipated difficult airway.
• Allergy to any of the drugs used in the study
• Any apparent deformity in the spine.
• Hemodynamic instability.
• Fetal distress.
• Surgically complicated cases.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Al Aini Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Placenta Accreta

Interventions

Anesthesia, General

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia& ICU

Study Record Dates

• First Submitted: April 26, 2025
• First Posted: August 6, 2026
• Study Start: January 25, 2025
• Primary Completion: November 25, 2025
• Study Completion: December 30, 2025
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)