Breast CancerNCT02821676
PECI/SPB vs Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
A study of Breast Cancer, run by Ottawa Hospital Research Institute.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast Reconstruction using the Latissimus Dorsi Flap
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast Reconstruction, Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast Reconstruction
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast ReconstructionProcedure or surgery
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
Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast ReconstructionProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| PEC1/SPB Block | Experimental | Not described Receives: Procedure: PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast Reconstruction |
| Intercostal Block | Active comparator | Not described Receives: Procedure: Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total 24 Hour Narcotic Usage
This is the most common primary outcome used in the regional anesthesia literature when comparing nerve blocks.
Measured: 24 hours
Secondary outcomes (6)
Time to first analgesic request (TFA)
Measured: 24 hours
Postoperative Pain score at 0h, 1h, 3h, 5h, 24 hours
Measured: 24 hours
Patient self reported pain score at 24 hours post-surgery
Measured: 24 hours
Peak expiratory flow rate
Measured: 24 hours
Breast Q Questionnaire
Physical and Psychological well-being questionnaire after breast reconstruction
Measured: 24 hours
QoR-40 Patient Satisfaction Questionnaire
Perioperative Care Satisfaction Questionnaire
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Zhang, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02821676
- Sponsor's protocol ID
- 20160235-01H
- Status last verified
- Jun 2016
- First submitted
- 31 May 2016
- Last updated
- 1 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Individual participant data will not be made available. Anonymity will be maintained throughout the study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Comparison of PECI/SPB Versus Intercostal Nerve Block for the Management of Postoperative Pain in Latissimus Dorsi Flap Reconstruction
- ClinicalTrials.gov ID
- NCT02821676
- Acronym / sponsor ID
- 20160235-01H
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 1 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast Reconstruction using the Latissimus Dorsi Flap
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast Reconstruction30mL 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 | Procedure or surgery | PEC1/SPB Block |
| Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast Reconstruction30mL 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 | Procedure or surgery | Intercostal Block |
Primary outcome
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.
6 secondary outcomes
Time to first analgesic request (TFA)
Time frame: 24 hours
Postoperative Pain score at 0h, 1h, 3h, 5h, 24 hours
Time frame: 24 hours
Patient self reported pain score at 24 hours post-surgery
Time frame: 24 hours
Peak expiratory flow rate
Time frame: 24 hours
Breast Q Questionnaire
Time frame: 24 hours
QoR-40 Patient Satisfaction Questionnaire
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2016.
- Individual participant dataSharing planned: Yes. Individual participant data will not be made available. Anonymity will be maintained throughout the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study of Breast Cancer, run by Ottawa Hospital Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J Stein, MD (6132864646, micstein@toh.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total 24 Hour Narcotic Usage (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2016.