NCT04824300

Efect of Erector Spina Plane Block on Mastectomy

Completed NA Last updated 18 June 2021

What this trial tests

NA trial testing erector spinae block in Pain, Postoperative in 42 participants. Completed in 25 February 2021.

Timeline

1 November 2020

Primary endpoint
23 February 2021

25 February 2021

Quick facts

Lead sponsor	Marmara University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	42
Start date	1 November 2020
Primary completion	23 February 2021
Estimated completion	25 February 2021
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• erector spinae block

Conditions studied

• Pain, Postoperative — all drugs for Pain, Postoperative →
• Opioid Use — all drugs for Opioid Use →

Sponsor

Marmara University

Who can join

Adults 18 to 70, female only, with Pain, Postoperative or Opioid Use. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.