- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02821676
PECI/SPB vs Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
A Randomized Controlled Comparison of PECI/SPB Versus Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Recent literature has unequivocally demonstrated that postoperative pain remains under-treated in hospitals. While breast surgery remains one of the most common surgeries performed in hospitals today, it has been shown that 40% of women still experience meaningful pain postoperatively. It is well known that poor pain control is not only associated with slower recovery, longer admission in hospital and poor patient satisfaction but it also can lead to the development of chronic post surgical pain.
In recent years, regional nerve blocks have emerged as a promising adjunct to standard postoperative analgesic ladder protocols. The main advantage of regional anesthesia is the reduction of postoperative pain while limiting the amount of oral and intravenous narcotic use. The reduction of postoperative narcotic use is advantageous for the patient and caregiver alike as it reduces common side effects associated with such medications, such as drowsiness, nausea, vomiting, upset stomach and dizziness.
Regional anesthesia in breast reconstruction surgery commonly include thoracic epidurals, intercostal nerve blocks and paravertebal nerve blocks. To date, there remains no standard of care for perioperative pain management and it is usually left to the discretion of the surgeon and anesthesiologist involved to decide which pain blockade is preferable on a case by case basis. While paravertebral and intercostal nerve blocks have shown promising results, they do not provide a complete sensory block to the anterior chest wall, as innervation is supplied not only from the thoracic spinal nerves but also via medial and lateral pectoral nerves off the brachial plexus.
The pectoral nerve block is a novel interfascial block placed into the plane between pectoralis major and minor muscles and is particularly useful in reconstructive breast surgery involving subpectoral prosthesis. It has been associated with minimal analgesia postoperatively and is thought to be particularly useful in the daycare setting.
To the best of the knowledge of the investigators, the utility of the pectoral nerve block in pedicled Latissimus Dorsi breast reconstruction has not been investigated. A mixed PEC I/ Serratus Plane Block provides analgesia to the lateral and medial pectoral nerves, lateral and anterior branches of the T2-T4 spinal nerves, long thoracic nerve and thoracodorsal nerve, theoretically offering a more comprehensive block than the midaxillary intercostal block and with no additional morbidity to the patient. Furthermore, the intercostal nerve block is a blind technique that may be associated with higher failure rates compared to the more precise, ultrasound guided, PECI/SPB block.
In this study, the investigators plan to systematically investigate these two blocks in latissimus dorsi flap reconstruction in order to document optimal postoperative pain management.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Breast Reconstruction using the Latissimus Dorsi Flap
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PEC1/SPB Block
|
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
|
Active Comparator: Intercostal Block
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total 24 Hour Narcotic Usage
Time Frame: 24 hours
|
This is the most common primary outcome used in the regional anesthesia literature when comparing nerve blocks.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to first analgesic request (TFA)
Time Frame: 24 hours
|
24 hours
|
|
Postoperative Pain score at 0h, 1h, 3h, 5h, 24 hours
Time Frame: 24 hours
|
24 hours
|
|
Patient self reported pain score at 24 hours post-surgery
Time Frame: 24 hours
|
24 hours
|
|
Peak expiratory flow rate
Time Frame: 24 hours
|
24 hours
|
|
Breast Q Questionnaire
Time Frame: 24 hours
|
Physical and Psychological well-being questionnaire after breast reconstruction
|
24 hours
|
QoR-40 Patient Satisfaction Questionnaire
Time Frame: 24 hours
|
Perioperative Care Satisfaction Questionnaire
|
24 hours
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20160235-01H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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