Postoperative Analgesia in Breast Cancer Surgery: Safety and Efficiency of Ultrasound Guided Erector Spinae Plane Block

NCT03769428 | Completed

• 1 other identifier: erector-spinae
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer surgery is one of the most common surgeries, due to the high incidence of breast cancer. Unfortunately, patients experience significant postoperative acute pain, placing them at risk for increased clinical morbidity and the development of disabling chronic pain which may rich up to 55% . The intensity of perioperative pain experienced by the patient is one of the best predictors of chronic pain. However, postoperative analgesia in breast cancer surgery is difficult due to the extensive nature of the surgery and the complex innervation of the breast. Several newly described regional anesthesia techniques exist to control perioperative pain, including the Paravertebral block (PVB) which has been proved to be the most effective one. The anatomic proximity of the pleura and central neuraxial system makes it a particularly challenging technique and carrying a risk of pneumothorax. The Erector Spinae Plane Block (ESPB) is a novel interfascial plane block described by Forero et al in September 2016. Local anesthetic injection is performed beneath the erector spinae muscle. Local anesthetic (LA) expected to achieve paravertebral spread of three vertebral levels cranially and four levels caudally, blocking the dorsal and ventral rami of the spinal nerves.The easy, fast and safe execution of ESPB makes it a promising technique in the context of surgical pain during breast cancer surgery. There is no sufficient randomized controlled trials that assess the effectiveness of ESPB in controlling post-operative breast surgery pain. The main purpose of this study is to evaluate the postoperative analgesic effect of Ultrasound-guided ESPB in patients undergoing breast cancer surgery.

Conditions

Breast Cancer Surgery; Postoperative Analgesia

Keywords

opioid consumption; erector spinae plane block; breast surgery; analgesia; PCA morphine; Locoregional anesthesia; breast cancer surgery

Outcome Measures

Primary Outcomes (1)

• Comparing morphine consumption rates within 24h postoperative

  All patients will be provided with IV morphine PCA and morphine consumption within 24 hour postoperatively will be recorded for both groups.

  The first 24 hours postoperative

Secondary Outcomes (7)

• Assessment of pain in postoperative period via visual analogue scales (VAS) .

  The first 24 hours postoperative

• Total morphine demand

  During 24 hours postoperative

• Time to first request for morphine

  During 24 hours postoperative

• Requirement of rescue analgesia

  During 24 hours postoperative

• Total intraoperative consumption of Fentanyl.

  Intraoperative period

Study Arms (2)

group B:ESP block

ACTIVE COMPARATOR

Patients in the experimental arm will receive an erector spinae plane block prior to induction of general anesthetic :- 150 mg of Ropivacaine : 40cc of Ropivacaine (3.75mg/cc) * An intravenous patient controlled analgesia device will be given to the patients postoperatively

Procedure: erector spinae plane block

group P: Sham ESP block

PLACEBO COMPARATOR

Patients allocated to the placebo-control arm will receive a sham erector spinae plane block .they will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block:- 40 cc of normal saline will be injected -An intravenous patient controlled analgesia device will be given to the patients postoperatively

Procedure: sham erector spinae plane block

Interventions

erector spinae plane block PROCEDURE

The ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid. Then 40cc of Ropivacaine (3.75mg/cc) will be injected .The distribution will be observed in both cranial and caudal directions.

group B:ESP block

sham erector spinae plane block PROCEDURE

The sham ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next between the erector spinae muscle and transverse process. Then 40cc of normal saline will be injected.The distribution will be observed in both cranial and caudal directions.

group P: Sham ESP block

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• ASA I-II
• Undergoing unilateral breast cancer surgery

You may not qualify if:

• obesity (body mass index \>40 kg/m2)
• Preoperative chronic dependence upon opioid and NSAID medications
• History of psychiatric or neurological disease
• Patients with chronic pain syndromes
• allergy to local anaesthetics
• other contraindications to peripheral nerve blocks
• Patients' refusal to participate

Sponsors & Collaborators

• Ben marzouk Sofiene: lead

Study Sites (1)

Tunis maternity and neonatology center,

Tunis, 1007, Tunisia

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hayen Maghrebi, PROFESSOR

  UNIVERSITY OF TUNIS EL MANAR

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinical associate professor

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 7, 2018
• Study Start: December 17, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 24, 2019

Record last verified: 2019-12

Locations

TU (1)