Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2024-04-01

Brief Summary

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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)

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Detailed Description

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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%.

Conditions

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Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ultrasound guided Retrolaminar Block

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.

Group Type ACTIVE_COMPARATOR

ultrasound guided Retrolaminar Block

Intervention Type DRUG

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

ultrasound guided erector spinae

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.

Group Type ACTIVE_COMPARATOR

ultrasound guided Erector Spinae Plane

Intervention Type DRUG

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.

Interventions

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ultrasound guided Retrolaminar Block

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

Intervention Type DRUG

ultrasound guided Erector Spinae Plane

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes