Bilateral Ultrasound-Guided Erector Spinae Plane Block For Postoperative Analgesia in Breast Reduction Surgery

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

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-15

Study Completion Date

2021-09-01

Brief Summary

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Erector spinae plane (ESP) block is a novel block developed by Forero to treat severe neuropathic pain and was firstly reported in 2016. Anatomical and radiological investigations in fresh cadavers indicate that its site of action is likely at the dorsal and ventral rami of the thoracic spinal nerves. The ESP block has a clear and simple sonoanatomy, it is easy to perform, not time consuming and generally well tolerated by the patients. So, the investigators believed that the ESP block may be an effective and safer alternative to paravertebral block, epidural analgesia and other myofascial thoracic wall blocks in breast surgery and designed a prospective, randomised, placebo-controlled trial for pain management.

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Detailed Description

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Conditions

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Postoperative Pain Breast Hypertrophy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ESP block group

The bilateral erector spine plane (ESP) block will be performed with ultrasound guided, preoperatively. Following antiseptic preparation of block site with povidone iodine, ultrasound probe will be placed 3 cm lateral to spine at T5 level. After identifying the erector spinae muscle and transverse process, the overlying skin will be infiltrated with local anesthetics and 20 mL local anesthetics (10 mL 0.5% bupivacaine + 10 mL 1% lidocaine) will be injected deep to the erector spinae muscle. The same procedure will be performed on the other side. Also, patients will receive intravenous patient controlled analgesia with morphine, and 1 g acetaminophen for supplemental analgesia if pain score raises over 5/10 on NRS and 50 mg meperidine for rescue analgesic for persistent pain.

Interventions:

Procedure: Ultrasound guided erector spinae plane block Other: Standard Pain Followup and Monitorization

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type PROCEDURE

Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.

sham block

A sham block will be performed while looking for intended location for ESP block placement. Skin will be infiltrated with local anesthetics but ESP block will not be performed, instead of ESP block 2 mL subcutaneous saline injection will be applied.

Intervention: Sham block Other: Standard Pain Followup and Monitorization

Group Type SHAM_COMPARATOR

sham block

Intervention Type OTHER

A sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients.

Interventions

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Erector spinae plane block

Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.

Intervention Type PROCEDURE

sham block

A sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) I-II, 18-65 years of age, adult, female patients undergoing elective breast reduction surgery

Exclusion Criteria

* Coagulopathy
* Allergy to amide-type local anesthetics
* Infection at the ESP block injection site
* Severe obesity (BMI \> 35 kg/m2)
* Liver or renal deficiency
* Patients with anatomical deformities
* Recent use of analgesic drugs
* Patient refusal or inability to consent

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No