Pectoral Nerve Blockade in Mastectomy

NCT01943240 | Withdrawn Phase 4

• 1 other identifier: Pec block
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Our routine practice for patients undergoing mastectomy is to include paravertebral peripheral nerve blockade for postoperative analgesia. This study investigates whether the addition of another nerve block targeting the pectoral nerves will improve that analgesia.

Conditions

Postoperative Pain; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption in post anesthesia care unit (PACU)

  Up to 8 hours

Secondary Outcomes (4)

• Maximum pain score in PACU (numerical rating scale)

  Up to 8 hours

• Time to meet PACU discharge criteria

  Up to 8 hours

• Patient satisfaction with block

  1 day

• Postoperative nausea and vomiting (PONV)

  Up to 8 hours

Study Arms (2)

Group A

EXPERIMENTAL

Paravertebral peripheral nerve blockade with with 4 mL of 0.5% ropivacaine at each of six levels, plus 10 cc of 0.375% ropivacaine for pectoral nerve block

Drug: Paravertebral nerve block: 4 mL ropivacaine 0.5% at each of six levels; Drug: 10 cc of 0.375% ropivacaine pectoral nerve block

Group S

ACTIVE COMPARATOR

Paravertebral peripheral nerve blockade with 4 mL of 0.5% ropivacaine at each of six levels, plus 10 cc of normal saline for pectoral nerve block.

Drug: Paravertebral nerve block: 4 mL ropivacaine 0.5% at each of six levels

Interventions

Paravertebral nerve block: 4 mL ropivacaine 0.5% at each of six levels DRUG

Group A; Group S

10 cc of 0.375% ropivacaine pectoral nerve block DRUG

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years and older
• Able to provide own consent
• Simple mastectomy at University of New Mexico Hospital without planned axillary surgery

You may not qualify if:

• Spinal deformity or pathology
• Chest wall deformity or pathology
• BMI \>40
• Bilateral simple mastectomy
• Refusal of regional anesthesia
• Chronic pain
• History of recent drug or alcohol abuse
• History of recent psychiatric problems
• Allergies to lidocaine or ropivacaine
• Allergies to fentanyl or hydromorphone
• Surgery that extends beyond the original plan to include axillary exposure

Sponsors & Collaborators

• Timothy R Petersen: lead

Study Sites (1)

University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Breast Neoplasms

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nicholas Lam, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Information Specialist

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 16, 2013
• Study Start: March 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

US (1)