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

NCT06322316 | Completed DMC

• 1 other identifier: MS-492-2022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Analgesics; Opioids; Breast Neoplasms; Postoperative Pain; Mastectomy; Nerve block

Outcome Measures

Primary Outcomes (1)

• the total morphine consumed postoperatively for 24 hours

  the total morphine consumed postoperatively for 24 hours

  24 hours

Secondary Outcomes (3)

• the total intraoperative fentanyl consumption

  intraoperative

• duration of analgesia

  at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

• postoperative nausea and vomiting PONV as side effect of morphine

  at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively

Study Arms (2)

The Ultrasound-guided Retrolaminar Block (RLB) Group

ACTIVE COMPARATOR

Received a preoperative ultrasound-guided retrolaminar block using 20 ml levobupivacaine 0.25% 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.

Procedure: The Ultrasound-guided Retrolaminar Block Group

The Ultrasound-guided Erector Spinae Plane Block (ESPB) Group

ACTIVE COMPARATOR

Received a preoperative ultrasound-guided erector spinae plane block using 20 ml levobupivacaine 0.25%. 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 block needle was inserted in-plane in a cranial-to-caudal direction until contact was made with the T5 transverse process.

Procedure: The Ultrasound-guided Erector Spinae Plane Block Group

Interventions

The Ultrasound-guided Retrolaminar Block Group PROCEDURE

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.

Also known as: RLB

The Ultrasound-guided Retrolaminar Block (RLB) Group

The Ultrasound-guided Erector Spinae Plane Block Group PROCEDURE

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.

Also known as: ESPB

The Ultrasound-guided Erector Spinae Plane Block (ESPB) Group

Eligibility Criteria

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

You may qualify if:

• Female patients
• Type of surgery; Modified Radical Mastectomy (MRM)
• Physical status ASA I, II, III.
• Age ≥ 18 and ≤ 65 Years.
• Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

You may not qualify if:

• Age \<18 years or \>65 years
• BMI \<20 kg/m2 and \>35 kg/m2
• Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids).
• History of psychological disorders and/or chronic pain.
• Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
• Patient refusal.
• Severe respiratory or cardiac disorders.
• Advanced liver or kidney disease.
• Pregnancy.
• Physical status ASA IV and Male patients.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National cancer Insititute Cairo university

Cairo, 11796, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Agnosia; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Model Details: To determine the analgesic effect of ultrasound guided Retrolaminar Block and Erector Spinae Plane Block in patients undergoing modified radical mastectomy regarding the following : 1-Post-operative opioid (morphine) consumption in the 1st 24 hours 2- Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 21, 2024
• Study Start: October 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)