Efect of Erector Spina Plane Block on Mastectomy

NCT04824300 | Completed DMC

• 1 other identifier: 09.2020.125
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

After breast cancer surgery, more than 60% of patients experience persistent pain.Although opioids are the main method of use in postoperative pain management, there are side effects such as constipation, sedation, respiratory depression, urinary retention, itching, postoperative nausea and vomiting.Erector spina plane block (ESPB) is a technique used in many surgeries for anesthesia and analgesia.It is frequently preferred by anesthesiologists for postoperative analgesia recently because it is easy to apply and no complications are reported in the literature.ESPB with arms of iliocostalis, longissimus and spinalis, is located parallel to the spine, from the back of the skull to the pelvis.The injected local anesthetic is distributed in many levels in the cranio-caudal direction and blocks the intercostal spinal nerves, causing sensory block.Providing the necessary perioperative analgesia due to the complex innervation of the breast tissue is a big controversy among anesthesiologists.Multimodal analgesia methods with various regional blocks are more preferred.ESPB block is also preferred as another method since it provides both perioperative and postoperative analgesia.In studies conducted on cadavers, it has been shown that local analgesia spreads to the paravertebral area when applied under the Erektor Spina muscle.Technically, compared to the paravertebral block,the ESPB has proven to be more reliable and easier in terms of pleural puncture risk. ANI is a monitoring method used in the evaluation of acute nociception and pain.Analyzes the instantaneous changes in heart rate due to the activation of the parasympathetic nervous system using respiratory sinus arrhythmia.A value between 0-100 is obtained.If parasympathetic modulation is very low, a value of 0 is obtained, if it is high, a value of 100 is obtained.ANI detects the noxious stimulus more specifically and sensitively than heart rate and blood pressure changes. Application of anesthesia and having ANI value between 50-70 in the early postoperative period indicates that analgesia is sufficient,and values \<50 are the following 10 minutes.Hemodynamic reactivity (20% increase in heart rate or blood pressure) will occur and the level of analgesia is insufficient,and values\> 70 indicate that there is no painful stimulus or that more analgesic drugs are used.

Conditions

Pain, Postoperative; Opioid Use

Keywords

erector spinae plane block; opioid consumption; mastectomy; Analgesia nosiseption index

Outcome Measures

Primary Outcomes (1)

• intraoperative opioid consumption

  measurement with analgesia nosiception index monitor

  during surgery

Secondary Outcomes (1)

• postoperative changes in vas ( visual analog scor)

  postoperative first 24 hours.

Study Arms (2)

erector spinae plane block group

ACTIVE COMPARATOR

All patients were monitored with standard monitoring (electrocardiography (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO2)), bispectral index (BIS, Medtronic, Mineapolis) and ANI (analgesia nociception index) -90-120 min) data were recorded.Group ESPB was applied before general anesthesia by the same anesthesiologist with block experience. In the sitting position, using an ultrasound-guided linear probe (6-13 MHz) on the side to be operated, T3 is marked 3 cm from the lateral of the spinous processes and with the in-plane technique, a 22G block needle (100mm, B-Braun, Germany) in the cranio-caudal direction first After it was observed that the erector spina muscle was separated from the transverse process with -2 ml normal saline, 20 ml 0.5% bupivacaine and 100 mg lidocaine were administered. And the drug was found to spread to the craniocaudal line at the ESP on ultrasound.Postoperative pain of the patients was evaluated using VAS (visual analogue scale).

Procedure: erector spinae block

non block control group

NO INTERVENTION

All patients were monitored with standard monitoring (electrocardiography (ECG), noninvasive blood pressure, peripheral oxygen saturation (SpO2)), bispectral index (BIS, Medtronic, Mineapolis) and ANI (analgesia nociception index) -90-120 min) data were recorded.15 minutes before the end of the surgery, 1 gr paracetamol and 100 mg tramadol were given to the control group. Postoperative pain of the patients was evaluated using VAS (visual analogue scale).

Interventions

erector spinae block PROCEDURE

Erector spina plane block (ESP) is a technique used in many surgeries for anesthesia and analgesia. It is frequently preferred by anesthesiologists for postoperative analgesia recently because it is easy to apply and no complications are reported in the literature. Erector spina muscle, with arms of iliocostalis, longissimus and spinalis, is located parallel to the spine, from the back of the skull to the pelvis. The injected local anesthetic is distributed in many levels in the cranio-caudal direction and blocks the intercostal spinal nerves, causing sensory block. Providing the necessary perioperative analgesia due to the complex innervation of the breast tissue is a big controversy among anesthesiologists. Multimodal analgesia methods with various regional blocks are more preferred. Erector Spina Plane block is also preferred as another method since it provides both perioperative and postoperative analgesia

erector spinae plane block group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult female patients ASA 1-3 25-70 years old were included in the study.

You may not qualify if:

• Severe respiratory and heart disease liver or kidney failure coagulopathy local infection at the injection site spine or chest wall deformity allergy to drugs to be used opioid addiction

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, Maltepe, 34854, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• MELIHA ORHON ERGUN

  Marmara University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 1, 2021
• Study Start: November 1, 2020
• Primary Completion: February 23, 2021
• Study Completion: February 25, 2021
• Last Updated: June 18, 2021

Record last verified: 2021-06

Locations

TU (1)