Expired Study
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Chicago, Illinois 60611


Purpose:

Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.


Study summary:

One in eight women will develop breast cancer in her lifetime, and many of these women undergo mastectomy followed by breast reconstruction by insertion of a tissue expander below the pectoralis major muscle. Women undergoing breast reconstruction have been shown to have a significantly higher level of acute postoperative pain and postoperative narcotic requirement compared to women who undergo mastectomy alone without reconstruction. In addition to the inherently worthwhile end of providing patient comfort in the immediate postoperative period, decreased narcotic use carries with it the potential benefit of decreasing the incidence of other adverse effects such as nausea, vomiting, allergic reaction, and respiratory depression. Importantly, the intensity of pain in the immediate postoperative period has been implicated as an important factor predisposing patients to the development of chronic postoperative pain. Chronic pain following mastectomy is a significant and disabling problem, affecting up to 49% of patients in some series. Though breast reconstruction has been shown not to be an independent predictor of the development of chronic breast pain, improved control of acute pain in the immediate postoperative period carries significant promise in decreasing the incidence of this disabling condition for all breast cancer survivors treated with mastectomy. In addition, improving management of acute postoperative pain can shorten hospital stay, expedite return to daily normal activities and increase patient satisfaction. A variety of other adjuncts for pain control have been attempted in studies of variable methodological rigor, including injection of botulinum toxin into the pectoralis muscle, indwelling pain catheters, paravertebral blocks under ultrasound guidance, or simple irrigation of the general area of dissection during breast surgery with a solution containing local anesthestic. While each of these adjuncts has demonstrated some success, none has been widely adopted. Problems with these methods include cost, risk of adverse events, as well as anatomically incomplete or non-selective application. During mastectomy all breast tissue is removed, leaving the patient with denervated skin flaps. For breast reconstruction, a tissue expander is placed in a subpectoral pocket dissected between the pectoralis major and minor muscles. At the end of the procedure the pectoralis major muscle is placed under variable degree of tension depending on the amount of fluid placed inside the expander. This muscle stretch believed to be at least partially responsible for postoperative pain. In addition cut nerve endings in the superficial fascia likely contribute as well. The anatomy of nerves supplying the breast and involved muscles are well-described in rigorous cadaver studies. In this study we hypothesize that performing a block of the intercostal nerves responsible for innervating the breast tissue and skin and the pectoral nerves innervating the pectoralis major muscle should optimize immediate postoperative pain control in this patient population. Of adjuncts described in the literature, paravertebral blocks are the most anatomically targeted, but drawbacks include the need for a separate procedure preoperatively while the patient is awake by an anesthesiologist with facility performing these blocks as well as the risk of pneumothorax. Advantages of our proposed method include lack of pain as the patient is asleep, easy and speed of application, a decreased risk of pneumothorax as the injections are under direct visualization, as well as a decrease in cost and improved efficiency as the only a single provider (i.e. the operative surgeon) is required. Precedent for our technique has been described in the context of breast augmentation and breast lift, with a favorable safety profile and providing adequate analgesia to perform these procedures without the use of a general anesthetic.


Criteria:

Inclusion Criteria: - Patients who undergo mastectomy surgery with immediate reconstruction involving insertion of a tissue expander performed by the principal investigator beginning from the time of study approval until study enrollment is complete. Exclusion Criteria: - Patients under the age of 18, or over the age of 79 - Allergy to local anesthetics or corticosteroids - Patients with history of chronic pain or with chronic use of opioid analgesics - Patients with history of lung disease or prior anterior thoracotomy or median sternotomy


Study is Available At:


Original ID:

STU00200903


NCT ID:

NCT02525718


Secondary ID:


Study Acronym:


Brief Title:

Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction


Official Title:

Does Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction Reduce Postoperative Pain and Opioid Requirement?: A Prospective Double-Blinded Randomized Controlled Trial


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Female


Minimum Age:

18 Years


Maximum Age:

79 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Northwestern University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

47


Enrollment Type:

Actual


Overall Contact Information

Official Name:Mohammed Alghoul, MD
Principal Investigator
Northwestern University

Study Dates

Start Date:August 2015
Completion Date:March 2017
Completion Type:Actual
Primary Completion Date:November 2016
Primary Completion Type:Actual
Verification Date:July 2019
Last Changed Date:July 24, 2019
First Received Date:July 6, 2015
First Results Date:July 3, 2019

Study Outcomes

Outcome Type:Primary Outcome
Measure:Quality of Recovery Score
Time Frame:24 hours post-operatively
Safety Issues:False
Description:The primary outcome measure is a well-validated and widely used survey measuring the quality of recovery from anesthesia entitled the "Global 40 Item Quality of Recovery" survey. This is a 40 question survey administered to patients to allow them to rate
Outcome Type:Secondary Outcome
Measure:Pain Score Using 10-point Visual Analog Scale (VAS)
Time Frame:24 hrs
Safety Issues:False
Description:A study-specific pain form was provided to the patient and nursing staff that consisted of standard visual analogue scale (VAS) for patients to rate their pain level. Pain level was rated as a categorical level from 0 to 10, in 1 unit increments, with 0 b
Outcome Type:Secondary Outcome
Measure:Opioid Consumption
Time Frame:24 hrs
Safety Issues:False
Description:Total opioid consumption in the first 24 hrs of recovery after surgery as measured in "morphine equivalents." This involves converting the dose of a non-morphine narcotic (e.g. IV hydromorphone or oral hydrocodone) into the equi-analgesic dose of morphine
Outcome Type:Secondary Outcome
Measure:Length of Hospital Stay
Time Frame:4 days
Safety Issues:False
Description:Number of postoperative days patients stay in the hospital after surgery

Study Interventions

Intervention Type:Drug
Name:Saline
Description:If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)
Arm Name:Placebo
Other Name:Sodium Chloride 0.9%
Intervention Type:Drug
Name:0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinep
Description:If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine. (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively.
Arm Name:0.25 % bupivacaine w/ epinephrine & 4mg dexame
Other Name:Bupivacaine

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:Placebo
Description:Subjects will be randomly selected to receive saline (placebo), administered to the breast area to cover the intercostal nerves supplying the breast tissue during surgery.
Study Arm Type:Active Comparator
Arm Name:0.25 % bupivacaine w/ epinephrine & 4mg dexamethasone
Description:Subjects will be randomly selected to receive selective block with a local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone. The injection will be performed in certain locations of the breast area to cover the intercostal nerves supplying the breast tissue. Subjects will be randomly selected to receive the local anesthetic solution containing 0.25 % bupivacaine (2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasoneadministere

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Northwestern University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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