PECI/SPB vs Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction

NCT02821676 | Unknown DMC

• 1 other identifier: 20160235-01H
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

Brief Summary

Regional Anesthesia is a procedure in which numbing medication is injected around nerves that transmit pain from areas involved in a surgery. The objective is to block the nerves so a patient does not feel pain after surgery. Regional nerve blocks offer many advantages over traditional anesthetic techniques, including faster recovery time, fewer side effects and a dramatic reduction in post-surgical pain. The use of regional anesthesia in breast reconstructive surgery, such as the latissimus dorsi flap, has led to major improvements in patient care. Today, the most common regional anesthetic used in latissimus dorsi flap reconstruction is the intercostal nerve block, where numbing medication is injected around the nerves supplying the chest wall. While intercostal nerve blocks have been used successfully in breast surgery, they do not provide a complete nerve block to the chest wall, as there are some nerves that are unaccounted for in the block which can contribute to a patients pain after surgery. The mixed pectoral one / serratus plane block (PECI/SPB) block is another regional nerve block that has been successfully used by anesthesiologists at The Ottawa Hospital and offers a more complete pain blockade than the intercostal nerve block, as it includes more nerves that supply the breast. In addition to this, the intercostal nerve block is a so-called "blind-technique" compared to the PECI/SPB block, which is more accurately guided by ultrasound. Blind techniques are associated with higher failure rates. Both the intercostal nerve block and the PECI/SPB nerve block have been used successfully at the Ottawa Hospital. In this study, the investigators propose a prospective, double blinded, randomized controlled, head to head comparison of the PECI/SPB and intercostal nerve block to determine which block is associated with the best pain blockade and patient satisfaction in lattissimus dorsi flap surgery.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Total 24 Hour Narcotic Usage

  This is the most common primary outcome used in the regional anesthesia literature when comparing nerve blocks.

  24 hours

Secondary Outcomes (6)

• Time to first analgesic request (TFA)

  24 hours

• Postoperative Pain score at 0h, 1h, 3h, 5h, 24 hours

  24 hours

• Patient self reported pain score at 24 hours post-surgery

  24 hours

• Peak expiratory flow rate

  24 hours

• Breast Q Questionnaire

  24 hours

Study Arms (2)

PEC1/SPB Block

EXPERIMENTAL

Procedure: PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast Reconstruction

Intercostal Block

ACTIVE COMPARATOR

Procedure: Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast Reconstruction

Interventions

PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast Reconstruction PROCEDURE

30mL of 0.5% Ropivacaine with 1:200,000 epinephrine preoperatively via an ultrasound guided PECI/SPB regional block and 5mL of Normal Saline intraoperatively as an intercostal nerve block to each of the T2-T7 nerve segments

PEC1/SPB Block

Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast Reconstruction PROCEDURE

30mL of Normal Saline via an ultrasound guided PECI/SPB block and 5mL of 0.5% Ropivacaine with 1:200,000 epinephrine as an Intercostal nerve block to each of the T2-T7 nerve segments

Intercostal Block

Eligibility Criteria

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

You may qualify if:

• Breast Reconstruction using the Latissimus Dorsi Flap

You may not qualify if:

• All patients undergoing breast reconstruction using techniques other than the pedicled latissimus dorsi myocutaneous flap
• Preexisting diagnosis of a chronic pain disorder
• BMI \> or = to 35/kg/m2
• History of allergy or sensitivity to local anesthetic
• History of coagulopathy or bleeding disorder
• Weight \<50Kg
• Allergies to local anesthetic, celecoxib, acetaminophen, hydromorphone

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Michael J Stein, MD

CONTACT

6132864646; micstein@toh.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Plastic Surgeon

Study Record Dates

• First Submitted: May 31, 2016
• First Posted: July 1, 2016
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: July 1, 2016

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will share