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

• Sponsor: Ain Shams University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06022614
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 1.5
• Patients Per Site Per Month: 38.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Erector Spinae Plane Block	Drug: Use Bupivacaine 0.25% Injectable Solution; Drug: Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in Ultrasound Guided Erector Spinae Plane Block for Post Modified Radical Mastectomy Pain Management
• Actual Study Start Date: Aug 15, 2023
• Anticipated Primary Completion Date: Sep 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Patients receiving Block with Bupivacaine only consists of patients receiving erector spinae plane block with Bupivacaine only	Drug: Use Bupivacaine 0.25% Injectable Solution; Group A Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml normal saline.
Active Comparator: Patients receiving Block using Bupivacaine with Dexmedetomidine consists of patients receiving erector spinae plane block using bupivacaine with Dexmedetomidine	Drug: Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine; Group B Patients receiving 20 ml Bupivacaine 0.25% added to 1 ml dexmedetomidine

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine Ain Shams University	Cairo		Egypt	1181

Sponsors and Collaborators

• Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ain Shams University
• ClinicalTrials.gov Identifier: NCT06022614
• Other Study ID Numbers: erector spinae plane block
• First Posted: Sep 5, 2023
• Last Update Posted: Sep 5, 2023
• Last Verified: Aug 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dexmedetomidine; Bupivacaine; Pharmaceutical Solutions

Study Results

No Results Posted as of Sep 5, 2023