Dexmedetomidine Versus Dexamethasone as Adjuncts in Erector Spinae Plane Block in Modified Radical Mastectomy

NCT05447949 | Completed

• 1 other identifier: MS-536-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the analgesic efficacy and safety of adding dexmedetomidine versus dexamethasone to levobupivacaine in ultrasound guided ESPB for patients undergoing modified radical mastectomy

Conditions

Breast Cancer; Post Operative Pain

Keywords

Modified Radical Mastectomy; Dexmedetomidine; Dexamethasone; Erector Spinae Plane Block; Regional anesthesia

Outcome Measures

Primary Outcomes (1)

• Total amount of morphine consumed postoperatively for 24 hours.

  Total amount of morphine consumed postoperatively in mg for 24 hours.

  24 hours

Secondary Outcomes (9)

• Total amount of fentanyl consumed intraoperatively.

  Duration of surgery

• Change in heart rate intraoperatively

  Duration of surgery

• Change in mean arterial blood pressure intraoperatively

  Duration of surgery

• Postoperative sedation according to Ramsay scores.

  24 hours

• Time to first rescue analgesia.

  24 hours

Study Arms (3)

Group 1 (ESPB + Dexmedetomidine)

EXPERIMENTAL

Patients received Ultrasound guided ESPB with addition of dexmedetomidine 1 Mcg/kg to 30 ml levobupivacaine 0.25%, N=30 (16)

Procedure: Adjuncts to levobupivacaine in Erector Spinae Plane Block

Group 2 (ESPB+ dexamethasone)

EXPERIMENTAL

Patients received Ultrasound guided ESPB with addition of dexamethasone 10 mg to 30 ml levobupivacaine 0.25%, N=30 (16)

Procedure: Adjuncts to levobupivacaine in Erector Spinae Plane Block

Group 3 (ESPB)

ACTIVE COMPARATOR

Patients received Ultrasound guided ESPB with 30 ml levobupivacaine 0.25%, N=30

Procedure: Adjuncts to levobupivacaine in Erector Spinae Plane Block

Interventions

Adjuncts to levobupivacaine in Erector Spinae Plane Block PROCEDURE

The block level will be at T5 with the patient in a sitting position and full aseptic precautions. T5 transverse process; these are recognizable as flat, squared-off acoustic shadows with only a very faint image of the pleura visible. In a longitudinal US view, in which the following layers will be visible superficial to the transverse processes: skin, subcutaneous tissue, trapezius, erector spinae muscle . Skin is topicalized, then echogenic block needle inserted in plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process. After aspiration; to avoid intravascular injection, 30 ml of injectate is injected and separation will be seen. 6-13-MHz, linear transducer set for small parts and a depth of 4-6 cm will be used (18-19).

Group 1 (ESPB + Dexmedetomidine); Group 2 (ESPB+ dexamethasone); Group 3 (ESPB)

Eligibility Criteria

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

You may qualify if:

• Type of surgery; Modified Radical Mastectomy (MRM)
• Physical status ASA II, III.
• Age ≥ 18 and ≤ 65 Years.
• Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

You may not qualify if:

• Patient's refusal
• Age \<18 years or \>65 years
• BMI \<20 kg/m2 and \>35 kg/m2
• Known sensitivity or contraindication to drug used in the study (local anaesthetics, opioids).
• History of psychological disorders and/or chronic pain.
• Contraindication to regional anaesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy.
• Severe respiratory or cardiac disorders.
• Advanced liver or kidney disease. Pregnancy.
• Physical status ASA IV.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ashgan R Ali, Professor

  Anaesthesiology Faculty of Medicine - Cairo University

  STUDY CHAIR

• Heba I Ahmed, Ass. Professor

  Anaesthesiology Faculty of Medicine - Cairo University

  STUDY DIRECTOR

• Reham M Gamal, Lecturer

  Anaesthesiology National Cancer Institute - Cairo University

  STUDY DIRECTOR

• Mohammed M Abdelrahman, Ass. Lecturer

  Anaesthesiology National Cancer Institute - Cairo University

  STUDY DIRECTOR

• Norhan H El Emam, Resident

  Anaesthesiology National Cancer Institute - Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the investigator for postoperative pain and the patients will be blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology , ICU and Pain Management

Model Details: Randomized

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: July 7, 2022
• Study Start: December 15, 2020
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: July 7, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)