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Analgesic Efficacy of U/S Retrolaminar Block and Erector Spinae Plane Block in MRM

NCT06322316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-03-21

No results posted yet for this study

Summary

Modified radical mastectomy (MRM) is the most commonly performed surgical procedure in breast cancer patients and is usually associated with severe postoperative pain. The peripheral nerve block techniques were suggested to reduce acuter post-mastectomy pain. The study compared the analgesic efficacy of retrolaminar block (RLB) and ESPB in patients undergoing MRM.

Conditions

  • Breast Neoplasms
  • Analgesia

Interventions

PROCEDURE

The Ultrasound-guided Retrolaminar Block Group

The ultrasound probe was placed on the back in a transverse orientation on the lateral side of the posterior median line to identify the lamina of the 5th vertebra, ESM, and transversospinalis muscles of the target segment. A 38-mm 22-gauge regional block needle was advanced using an in-plane technique. When the puncture needle touched the lamina, 20 mL of 0.25% levobupivacaine was administered between the transversospinalis muscle and lamina. The LA diffusion between the lamina and the ESM indicated a successful puncture.

PROCEDURE

The Ultrasound-guided Erector Spinae Plane Block Group

The ultrasound probe was placed on the back in a transverse orientation to identify the tip of the T5 transverse process as flat, squared-off acoustic shadows with a faint image of the pleura visible. When the tip of the transverse process was centered on the ultrasound screen, the probe was rotated to a longitudinal orientation. In the parasagittal view, the following layers were visible superficial to the acoustic shadows of the transverse processes: skin and subcutaneous tissue, trapezius, ESM, and T5 transverse process. The block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process. The correct location of the needle tip in the fascial plane deep to the ESM was confirmed by injecting 0.5-1.0 ml of normal saline and seeing the fluid lifting the ESM off the transverse process without distending the muscle. Then 20 ml levobupivacaine 0.25% was injected.

Sponsors & Collaborators

  • National Cancer Institute, Egypt

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2023-03-01
Completion
2023-04-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06322316 on ClinicalTrials.gov