Comparative Analysis of Three Locoregional Anesthesia Methods in Breast Tumour Pathology Surgery

NCT05185752 | Completed

• 1 other identifier: Ref. 070/2018
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The present study compares the Erector Spinae Plane (ESP) block, Pectoral (PECS II) block, and Serratus-Intercostal Fascial Plane (SIFP) block. This is the first article to compare these three locoregional nerve block techniques in acute and chronic postoperative pain in breast tumour surgery. From June 1, 2018, to June 30, 2019, 103 patients undergoing breast cancer surgery were randomised to undergo one of three locoregional techniques (35 for ESP block, 34 for PECS II block, 34 for SIFP block). Locoregional techniques were performed under light sedation and then, general anaesthesia was used for the breast cancer surgery. Outcomes measured included pain (visual analog scale \[VAS\] in immediate postoperatory and at 24 hours. It also was collected opioid use at 24 hours, adverse events, and length of stay (for acute postoperatory). Moreover, at 3 months, a telephone interview was conducted with the patient and VAS was questioned. A year later, the patient was questioned again and asked for VAS, location of her pain, and pharmacological treatment. It was collected if patients were assisted or not by a Pain Unit.

Conditions

Postoperative Pain; Chronic Post Operative Pain; Breast Tumor; Locoregional Anesthesia; Breast Pain

Keywords

ESP block; PECS block; SIFP block; breast tumor surgery; locoregional anesthesia

Outcome Measures

Primary Outcomes (6)

• Which technique presents less pain in visual analogue scale (VAS score) in the immediate postoperative

  Compare pain management in immediate postoperative period: Which technique presents less pain in visual analogue scale (VAS score), and also comparing this VAS score obtained with the preoperative VAS collected (baseline VAS). VAS is a one-dimensional pain scale (0-no pain; 1-3 mild pain; 4-7 moderate pain; 8-10 severe pain).

  Immediate postoperative

• Which technique presents less pain in visual analogue scale (VAS score) 24 hours after surgery

  Compare pain management in postoperative period (24 hours after surgery): Which technique presents less pain in visual analogue scale (VAS score), and also comparing this VAS score obtained with the preoperative VAS collected (baseline VAS). VAS is a one-dimensional pain scale (0-no pain; 1-3 mild pain; 4-7 moderate pain; 8-10 severe pain).

  24 hours after surgery

• Which technique presents less pain in visual analogue scale (VAS score) 3 months after surgery.

  Compare pain management in postoperative period (3 months after surgery): Which technique presents less pain in visual analogue scale (VAS score), and also comparing this VAS score obtained with the preoperative VAS collected (baseline VAS). VAS is a one-dimensional pain scale (0-no pain; 1-3 mild pain; 4-7 moderate pain; 8-10 severe pain).

  3 months after surgery

• Which technique presents less pain in visual analogue scale (VAS score) 1 year after surgery.

  Compare pain management in postoperative period (1 year after surgery): Which technique presents less pain in visual analogue scale (VAS score), and also comparing this VAS score obtained with the preoperative VAS collected (baseline VAS). VAS is a one-dimensional pain scale (0-no pain; 1-3 mild pain; 4-7 moderate pain; 8-10 severe pain).

  1 year after surgery

• Rate of participants that required opioid consumption.

  Which technique requires less opioid use; quantify opioid consumption in milligrams morphine equivalent (MME) and compare opioid consumption between the three study groups. Researchers record the opioid use required by patients and the results are converted into MME to make comparison possible.

  24 hours after surgery

• Rate of participants that required consumption of analgesia 1 year after surgery.

  Comparing the incidence of need of analgesic treatment 1 year after surgery between the three study groups: according to the World Health Organization (WHO) analgesic ladder that patients received one year after surgery. WHO analgesic ladder: Step I, treatment with paracetamol and NSAIDs. At step II, treatment with weak opioids; Step III, treatment with a strong opioid; Step IV, interventional pain techniques.

  1 year after surgery

Secondary Outcomes (4)

• Rate of participants that presented intraoperative hemodynamic alterations

  Intraoperative period; an average up to 12 hours.

• The Length (number of hours) of Hospital Stay: comparison between the three study groups.

  Number of hours from hospitalization; from Major Outpatient Surgery (0 hours) to 7 days (168 hours) Hospital Stay

• Assistance by Pain Unit: comparison between the three study groups.

  1 year after surgery

• Compare the incidence of location of chronic postoperative pain between the three study groups.

  1 year after surgery

Study Arms (3)

Erector Spinae Plane Block (ESP block)

ACTIVE COMPARATOR

The patient is positioned in the prone position, the probe is used to locate in cross-section the T4 spinous process. Next, using a lateral scan, approximately 3 cm away, the costotransverse joint is located, and then change to sagittal ultrasound vision. By locating the intertransverse line with the probe, the following anatomical structures can be identified: three longitudinal muscles (trapezius, rhomboid, erector spinae). The needle enters in a single punction at an angle of 45º, in the cranio-caudal direction, until it touches the apex of the costotransverse image. Subsequently, 30 cc of 0.25% bupivacaine are administered in the depth of the erector spinae, which will remain elevated.

Procedure: ESP block: Locoregional Interfascial Anesthesic Technique

Pectoral Nerve type II Block (PECS II block)

ACTIVE COMPARATOR

The patient is positioned supine, with the ipsilateral upper limb extended. The clavicular external third line is drawn. In parallel, the lower costal line and the infraclavicular space are highlighted. The probe obtains an image that allows the identification of the pectoralis major and pectoralis minor. If colour Doppler is added, the acromiothoracic artery is identified and must be avoided. The needle enters at an angle of 45º from medial to lateral, and 20 cc of 0.25% bupivacaine are administered. Next, needle advances in the interfascial space between the pectoral minor and serratus anterior and 10 cc of 0.25% bupivacaine are administered.

Procedure: PECS II block: Locoregional Interfascial Anesthesic Technique

Serratus-Intercostal Fascial Plane Block (SIFP block)

ACTIVE COMPARATOR

The patient is positioned supine, with the ipsilateral upper extremity at a 90º angle. The fourth, fifth, and sixth intercostal spaces are identified in the mid-axillary line. In coronal section, it is possible to appreciate the subcutaneous cellular tissue, the serratus anterior, and the intercostal muscles. The needle is introduced at an angle of 30º. From caudal to cranial and resting the needle on the fourth rib, 30 cc of 0.25% bupivacaine are administered between the serratus anterior and lateral intercostal muscles.

Procedure: SIFP Block Locoregional Interfascial Anesthesic Technique

Interventions

SIFP Block Locoregional Interfascial Anesthesic Technique PROCEDURE

Interfascial blocks emerged as locoregional techniques that incorporate ultrasonography to visualise the anatomy while administrating the drug, reducing the rate of complications. There are multiple locoregional interfascial techniques continue to be implemented; in 2011 Blanco described Pectoral Nerve Block (PECS block); in 2012, Serratus-Intercostal Fascial Plane Block (SIFP) was described, and in 2016, Forero described the Erector Spinae Plane Block (ESP). Drug: 30 cc 0.25% bupivacaine. Nerves blocked by SIFP block: lateral and anterior cutaneous branches of the 2nd-6th Intercostal Nerves. Devices: S-Nerve® ultrasound was used in all three techniques; linear 6 to 13 Megahertz and convex 2 to 5 Megahertz transducers and 22G (Gauge) x 50 mm needles.

Serratus-Intercostal Fascial Plane Block (SIFP block)

PECS II block: Locoregional Interfascial Anesthesic Technique PROCEDURE

Interfascial blocks emerged as locoregional techniques that incorporate ultrasonography to visualise the anatomy while administrating the drug, reducing the rate of complications. There are multiple locoregional interfascial techniques continue to be implemented; in 2011 Blanco described Pectoral Nerve Block (PECS block); in 2012, Serratus-Intercostal Fascial Plane Block (SIFP) was described, and in 2016, Forero described the Erector Spinae Plane Block (ESP). Drug: 30 cc 0.25% bupivacaine. Nerves blocked by PECS-II: Lateral Pectoral Nerve and Medial Pectoral Nerve Devices: S-Nerve® ultrasound was used in all three techniques; linear 6 to 13 Megahertz and convex 2 to 5 Megahertz transducers and 22G (Gauge) x 50 mm needles.

Pectoral Nerve type II Block (PECS II block)

ESP block: Locoregional Interfascial Anesthesic Technique PROCEDURE

Interfascial blocks emerged as locoregional techniques that incorporate ultrasonography to visualise the anatomy while administrating the drug, reducing the rate of complications. There are multiple locoregional interfascial techniques continue to be implemented; in 2011 Blanco described Pectoral Nerve Block (PECS block); in 2012, Serratus-Intercostal Fascial Plane Block (SIFP) was described, and in 2016, Forero described the Erector Spinae Plane Block (ESP). Drug: 30 cc 0.25% bupivacaine. Nerves blocked by ESP Block: dorsal and ventral branch block of the spinal nerves; white and gray communicating branches of the sympathetic nerves that go to the thoracic sympathetic chain. Devices: S-Nerve® ultrasound was used in all three techniques; linear 6 to 13 Megahertz and convex 2 to 5 Megahertz transducers and 22G (Gauge) x 50 mm needles.

Erector Spinae Plane Block (ESP block)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient undergoing elective surgery for breast tumour pathology.

You may not qualify if:

• Previous breast tumour pathology surgery.
• Breast prosthesis carrier.
• Coagulopathy.
• Pregnancy or lactation.
• Puncture site infection.
• Chest wall deformity.
• Hemodynamically unstable patient.
• Refusal of the patient to undergo locoregional technique.
• The patient refuses to take part in the study or revocation of the Informed Consent.

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

José De Andrés Ibáñez

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms; Mastodynia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jose De Andrés Ibáñez, MD, PhD

  jose.andres@uv.es

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The type of masking applied was: First part of study (until 24 hours after surgery): single-blind, the patient did not know what type of treatment he had received, but the anaesthesiologist in the operating room, and the main intraoperative and immediate postoperative period evaluator were aware of all this. Second part of study (3 months and 1 year after surgery): double-blind, the patient did not know what type os treatment he had received, and the anesthesiologist who was the responsible of collecting data through the telephone interview or her medical history, did not know the treatment taken by the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients undergoing breast tumour surgery were randomised to undergo one of three locoregional techniques in three study groups (Erector Spinae Plane block -ESP block-, Pectoral Nerve Block type II -PECS II block-, or Serratus-Intercostal fascial Plane Block-SIFP block). Locoregional techniques were performed under light sedation and then, general anaesthesia was used for the breast tumour surgery.

Study Record Dates

• First Submitted: November 16, 2021
• First Posted: January 11, 2022
• Study Start: June 1, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2020
• Last Updated: January 11, 2022

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)