Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia

Zagazig University

Status: Enrolling

Conditions: Analgesia

Treatments: Drug: ultrasound guided Retrolaminar Block; Drug: ultrasound guided Erector Spinae Plane

Study type: Interventional

Funder types: Other

Identifiers

NCT04531215

6236 (Other Identifier)

Details and patient eligibility

About

Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. PVB has the benefit of perception of the needle position using ultrasonography. However, PVB is also additionally connected with a danger of serious complications, such as pneumothorax, hypotension, or nerve injury. Newer approaches to deal with PVB have been the focal point of numerous techniques lately; these methodologies incorporate retrolaminar block (RLB) and erector spinae plane block (ESPB)

Full description

Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome.

Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.

The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.

As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.

Enrollment: 46 estimated patients

Sex: All

Ages: 21 to 64 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patient acceptance.
• 21 - 64 years of age.
• American Society of Anesthesiologist physical status class I,II.
• Body Mass Index 25-35 kg/m2.
• Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia.

Exclusion criteria

• Coagulation disorders or anticoagulant therapy.
• Known allergy to study drugs (Bupivacaine, Fentanyl)
• Infection at the injection site.
• Patients having chronic pain or on pain treatment.
• Advanced renal, respiratory, hepatic or cardiovascular disorders.
• Uncooperative patients.
• Duration of surgery > 3hours.
• Pregnant or lactating females.
• Metastasis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

ultrasound guided Retrolaminar Block

Active Comparator group

Description:

ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.

Treatment:

Drug: ultrasound guided Retrolaminar Block

ultrasound guided erector spinae

Active Comparator group

Description:

ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.

Treatment:

Drug: ultrasound guided Erector Spinae Plane