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

NCT06022614 | Completed

• 1 other identifier: erector spinae plane block
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Erector Spinae Plane Block

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Patients receiving Block with Bupivacaine only

ACTIVE COMPARATOR

consists of patients receiving erector spinae plane block with Bupivacaine only

Drug: Use Bupivacaine 0.25% Injectable Solution

Patients receiving Block using Bupivacaine with Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine

Interventions

Use Bupivacaine 0.25% Injectable Solution DRUG

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

Patients receiving Block with Bupivacaine only

Bupivacaine 0.25% Injectable Solution plus Dexmedetomidine DRUG

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

Patients receiving Block using Bupivacaine with Dexmedetomidine

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abanoub Habib: lead

Study Sites (1)

Faculty of Medicine Ain Shams University

Cairo, 1181, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: September 5, 2023
• Study Start: August 15, 2023
• Primary Completion: June 1, 2024
• Study Completion: July 1, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

EG (1)