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

Erector Spinae Plane Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06022614
• Other study ID #: erector spinae plane block
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: Ain Shams University
• Contact: Abanoub Habib, PHD
• Phone: 01283575659
• Email: abanoubmoureshabib[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erector Spinae Plane Block

Intervention

Drug:
• Use Bupivacaine 0.25% Injectable Solution
Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.
• Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine
Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the first time to request rescue analgesia.	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).	From the end of the surgery till 24 hours
Primary	The primary outcome will be the first time to request rescue analgesia	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.	From the end of the surgery till 24 hours