Ropivacaine 0,2% Plus Dexamethasone Versus Ropivacaine 0,2% Plus Placebo in Modified Pectoral Block

NCT ID: NCT03700177

Last Updated: 2020-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2020-12-31

Brief Summary

To find out if dexamethasone used as adjuvant to ropivacaine, a long-lasting local anesthetic, prolongs the duration of modified pectoral nerve block in women undergoing breast surgery.

Detailed Description

Breast surgeries are one of the most common forms of surgery conducted in hospitals, and even relatively minor interventions can be associated with significant postoperative pain. The most common surgical procedure for breast cancer is modified radical mastectomy, which means removing a generous amount of skin and the entire breast with axillary evacuation. According to the literature, up to 50% of breast surgery patients experience severe acute postoperative pain, with 10-40% breast cancer patients experiencing pain a year or more after surgery.

Poorly controlled postoperative pain has negative physiological and psychological consequences. Furthermore, effective acute pain control preserves immune function both by suppressing surgical stress response and decreasing the need for general anesthetics and opioids in the perioperative period.

The ultrasound-guided modified, pectoral nerve block is a frequently used, easy, and reliable technique to provide complete analgesia during and after breast surgery. A major limitation to its use for postoperative analgesia is that the analgesic effect lasts only a few hours, after which moderate to severe pain at the surgical site may result in the need for alternative analgesic therapy. Several adjuvants have been used to prolong the analgesic duration of peripheral nerve block, including perineural/interfascial or intravenous dexamethasone.

Our aim is to explore the efficacy of 8 mg dexamethasone added to US-guided modified pectoral nerve block on postoperative pain in patients undergoing major breast surgery.

Conditions

Effect of Drugs; Breast Pain; Anesthesia, Local

Study Design

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

Study Groups

ropivacaine + dexamethasone

Every participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml dexamethasone (8mg).

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

modified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg.

Ropivacaine Injection [Naropin]

Intervention Type: DRUG

30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)

ropivacaine + placebo

Every participant receives general anesthesia and a modified pectoral nerve block for breast surgery. Participants of this arm receive single-shot ropivacaine (0,2%, 30ml) plus 2ml placebo (NaCl 0,9%).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).

Ropivacaine Injection [Naropin]

Intervention Type: DRUG

30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)

Interventions

Dexamethasone

modified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg.

Intervention Type: DRUG

Placebo

modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).

Intervention Type: DRUG

Ropivacaine Injection [Naropin]

30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)

Intervention Type: DRUG

Other Intervention Names

Dexabene; sodium chloride (NaCl) 0,9%; Naropin

Eligibility Criteria

Inclusion Criteria

• female gender
• a American Society of Anesthesiologists (ASA) score of 1 or 2
• weight: body mass index (BMI) 18 - 35 kg/m2
• informed consent
• elective, unilaterale breast surgery

Exclusion Criteria

• bleeding disorders
• any known allergy to the medication
• diabetes mellitus
• any disease that leads to alterations in the corticosteroid physiology
• drug-dependency
• BMI <18 or > 35
• systemic infections
• psychiatric diseases, that are associated with an alteration in the perception of pain
• tumor spread at the site of injection
• inflammation at the site of injection
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University Innsbruck

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karl Lindner, Prof.Dr.

Role: STUDY_DIRECTOR

Department of Anesthesia and Intensive Care

Locations

Medical University of Innsbruck

Innsbruck, Tyrol, Austria

Site Status: RECRUITING

Countries

Austria

Central Contacts

Elisabeth Hoerner, DDr

Role: CONTACT

elisabeth.hoerner@tirol-kliniken.at

+43 512 504 83150

Guenther Putz, Prof.Dr.

Role: CONTACT

guenther.putz@tirol-kliniken.at

+43 512 504 22400

Facility Contacts

Elisabeth Hoerner, DDr.

Role: primary

elisabeth.hoerner@tirol-klniken.at

+4351250483150

Guenther Putz, AoUniv.Prof.

Role: backup

guenther.putz@i-med.ac.at

+4351250480275

Other Identifiers

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Identifier Type: -

Identifier Source: org_study_id