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

NCT ID: NCT06022614

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2024-07-01

Brief 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.

Detailed 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.

Conditions

Erector Spinae Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Patients receiving Block with Bupivacaine only

consists of patients receiving erector spinae plane block with Bupivacaine only

Group Type: ACTIVE_COMPARATOR

Use Bupivacaine 0.25% Injectable Solution

Intervention Type: DRUG

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

Patients receiving Block using Bupivacaine with Dexmedetomidine

consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine

Group Type: ACTIVE_COMPARATOR

Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Use Bupivacaine 0.25% Injectable Solution

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

Intervention Type: DRUG

Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Abanoub Habib

OTHER

Sponsor Role: lead

Responsible Party

Abanoub Habib

Dr

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Faculty of Medicine Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

erector spinae plane block

Identifier Type: -

Identifier Source: org_study_id