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

Ç

Çukurova University

Status

Completed

Conditions

Postoperative Pain
Breast Hypertrophy

Treatments

Other: sham block
Procedure: Erector spinae plane block

Study type

Interventional

Funder types

Other

Identifiers

NCT03621345
CukurovaUniv

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

Female

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

60 participants in 2 patient groups

ESP block group
Active Comparator group
Description:
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
Treatment:
Procedure: Erector spinae plane block
sham block
Sham Comparator group
Description:
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
Treatment:
Other: sham block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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