Skip to main content
OpenTrials
Completed

NCT Number: NCT06022614

Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in US Guided ESPB for Post MRM Pain Management

The aim of the study is to assess the effect of adding dexmedetomidine to bupivacaine in US guided erector spinae plane block in modified radical mastectomy surgeries , Using visual analogue score and post-operative narcotics consumption.

Peripheral nerve blocks are effective adjuvant options for pain management in breast surgeries. The use of Erector spinae plane block (ESPB) has been proven to be very effective in controlling pain and minimizing narcotic consumption after modified radical mastectomy surgeries.

Many adjuvants to local anaesthetics were used to improve the duration and intensity of the peripheral nerve block.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Erector Spinae Plane Block

Age range

30 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine Ain Shams University

Cairo, 1181, Egypt

About this study

Breast cancer is one of the most important medical problems in the female gender, since among every eight women, one will suffer from breast cancer during her lifetime.

Acute post-operative pain is very common after breast surgeries which requires adequate pain management. Different peripheral nerve blocks such as paravertebral block had been used as an analgesic option for breast surgeries.

Erector spinae plane block is a newer interfascial plane block first described in 2016 who used it for treating thoracic neuropathic pain by injecting a local anesthetic deep into the erector spinae muscle at the level of T5. Moreover, ESPB is a reasonable option, with clearly identifiable sonographic landmarks and LA needle insertion and injection locations.

Later studies have shown that ESPB can provide effective analgesia in breast surgeries.

ESPB is achieved by injecting the local anesthetics locally deep to erector spinae muscle surface, as a part of multimodal analgesia. Given that erector spinae muscles anatomically situate along the thoracolumbar spine, ESPB promotes an extensive craniocaudal spread.

Ultrasound is a non-invasive visualization technology that helps in capturing the anatomical structure of target tissues, it can help to guide the direction and depth of anesthesia puncture needles, thus reducing the risk of complications .

Adjuvants to local anesthetics, such as opioids, alpha 2 agonists, magnesium and dexamethasone may improve the duration and intensity of peripheral nerve blocks effect.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age:30-65years.
  • Physical status: ASA I,II.
  • BMI<35.
  • Localized breast cancer

Exclusion criteria

  • Age:<30 and >65 years.
  • Refusal of procedure or participation in the study by the patient.
  • Physical status: ASA III or above.
  • History of allergy to the study drug.
  • BMI>35.
  • Bleeding disorders and coagulopathy.
  • Psychiatric illness that may interfere with the study.
  • Metastatic breast cancer.

Treatment and study plan

Use Bupivacaine 0.25% Injectable Solution

Drug

Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.

Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine

Drug

Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine

Primary outcomes

  1. The primary outcome will be the first time to request rescue analgesia.

    Time frame: From the end of the surgery till 24 hours

    The investigators assess first time to request rescue analgesia according to A) pain score from 0 to 10 while 0 means no pain (best) and 10 means sever pain (worst).

  2. The primary outcome will be the first time to request rescue analgesia

    Time frame: From the end of the surgery till 24 hours

    B) patient hemodynamics ex. Heart rate if patient is tachypneic (HR more than 100 beat/min) which is means that the patient is in pain.

Sponsors and collaborators

Lead sponsor

Abanoub Habib

Other

Registry information

Official study title

Effect of Adding Dexmedetomidine As Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 5, 2023
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.