Pain, PostoperativeEarly Phase 1NCT03388814
Speeding Recovery From Pain and Opioid Use
A Early Phase 1 study testing Local infiltration of bupivacaine and Pectoralis Nerve block in people with Pain, Postoperative and Breast Cancer, run by Wake Forest University Health Sciences.
Trial summary
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Postoperative, Breast Cancer, Opioid Use
- What is being tested?
- Local infiltration of bupivacaine and Pectoralis Nerve block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jun 2020
- Phase
- Early Phase 1
- 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
- Patients scheduled for unilateral mastectomy with immediate issue expander and implant based reconstruction.
- Age ≥ 18 years
- Ability to understand, read, and write English, and the willingness to sign an IRB-approved informed consent document.
- Patients who receive a tissue expander placement will be included in the study.
- American Society of Anesthesiologists physical status I-III patients.
Who cannot join
- Patients who receive an autologous tissue reconstruction.
- Patients who receive a bilateral reconstruction.
- Patients who receive a direct to permanent implant reconstruction
- Patients with diagnosis of opioid misuse disorder or on high dose opioid therapy (greater than 100 mg equivalents of oral morphine per day)
- Patients who are wards of the state
- Patients who cannot read or speak English
Show all 9Show fewer
- History of allergic reactions attributed to compounds with known or suspected cross-sensitivity to bupivacaine.
- Pregnant or breast feeding
- Inability to access to the internet on a daily basis
About this study
Official title: Speeding Recovery From Pain and Opioid Use After Mastectomy and Breast Reconstruction Surgery
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. However, breast reconstruction at the same time as mastectomy has been linked to higher postoperative pain, which can be a risk factor for persistent pain. The goal of this study is to determine the speed of recovery from pain and opioid use in the first 2 months after breast surgery and reconstruction.
Read the detailed description
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. Surgical treatments can also negatively influence social exposure and alter self-perception and sexual health. Reconstruction of the breast mound following mastectomy has several benefits in psychosocial functioning, body image and satisfaction with breast appearance, and sexual well-being. However, reconstruction at the same time as mastectomy has been linked to higher postoperative pain. Compared to autologous breast reconstruction, implant based techniques have been linked to higher requirements of postoperative nonsteroidal anti-inflammatory drugs, opioids, and benzodiazepines as well as higher pain scores in the immediate postoperative period and one year after surgery. Recent publications report that intensity of pain in the operative area prior to surgery, body mass index (BMI), presence of axillary operation, intensity of acute postoperative pain, and amount of opioid required to achieve satisfactory analgesia in the acute postoperative period are also risk factors for persistent pain following breast cancer surgery (PPBCS). Since severity of acute postoperative pain is consistently observed as a risk factor for persistent pain, there has been interest in determining whether better acute pain control reduces this risk. Infiltration of the surgical site with bupivacaine decreases intraoperative and postoperative narcotic use, and has been associated with decreased pain scores in the immediate postoperative period. A novel approach to hemithoracic analgesia has been introduced which proposed less risk of anatomic trespass by doing a local anesthetic injection into the fascial planes of the chest wall. These procedures have demonstrated improved analgesia for breast surgeries. Unfortunately, there is a lack of large, multicenter, prospective, and randomized trials comparing these analgesic modalities and evaluating the response to these acute postoperative analgesic interventions with regard to PPBCS and other metrics of daily function, satisfaction with pain control, and self-perception of well-being and predictors of recovery from the pain state. The goals of this research are to provide short-term surrogate measures for prevention or treatment trials and to develop methods enabling practitioners to forecast recovery in real-time and that are translatable to patients in understandable references regarding risk over time.
- Conditions
- Pain, Postoperative, Breast Cancer, Opioid Use, Surgery
- Being tested
- Local infiltration of bupivacaine, Pectoralis Nerve block
- Keywords
- PPBCS, Acute, Postoperative, Mastectomy, Breast Reconstruction
- Medical subject headings
- Pain, Postoperative, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Local infiltration of bupivacaineDrug
Patients assigned to the local infiltration with bupivacaine group will receive 30 ml of 0.25% bupivacaine with 1:200,000 epinephrine. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. The local anesthetic will be injected into the chest wall and skin flaps. Attending physicians and resident physicians will receive prior instruction regarding correct placement of the local anesthetic so that it will be consistently placed in the same locations with similar volume distribution.
Pectoralis Nerve blockDrug
Patients assigned to the pectoralis block group will receive a total of 20 ml 0.25% bupivacaine (with 1:200,000 epinephrine and 1.67 mcg clonidine per ml) in the tissue plane between the serratus anterior and the pectoralis minor muscles at approximately the level of the 4th rib and 10 ml of the same solution in the tissue plane between the two pectoralis muscles at approximately the 3rd rib under ultrasound guidance on the surgical side preoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Group | Active comparator | Those patients randomized to surgeon infiltration will have a skin wheal performed with lidocaine at the site where an actual pectoralis nerve block would be performed as visualized using ultrasound. Surgeons performing infiltration techniques will be blinded to the contents of the injectate and those patients randomized to surgeon infiltration will receive pharmacy study drug labeled bupivacaine injected in the same fashion and volume as the saline group for oncologic and plastic surgery. Receives: Drug: Local infiltration of bupivacaine |
| Pectoralis Nerve block Group | Experimental | Those patients who are randomized to pectoralis nerve block will have randomization immediately preoperatively and will undergo the nerve block procedure using local anesthetic in the standard fashion. Those patients randomized to pectoralis block will have a standard volume of normal saline injected for oncologic and plastic surgery. Receives: Drug: Pectoralis Nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modeled worst pain intensity using the numeric rating scale (NRS)
NRS pain scores will be obtained daily from time of initiation into the study until 2 months after surgery and the scores following hospital discharge will be modeled for each individual using a growth curve change-point approach. The NRS has a 0-10 numeric rating scale (0=no pain and 10=worst pain imaginable), where lower scores denotes better outcomes.
Measured: From study start to 2 months after surgery
Secondary outcomes (4)
Area under the curve of the numeric rating scale (NRS)
The NRS has a 0-10 numeric rating scale (0=no pain and 10=worst pain imaginable), where lower scores denotes better outcomes.
Measured: During the first 48 hours postoperatively
Opioid use
Opioid use converted to morphine equivalents while in hospital and daily for the first 2 months after surgery
Measured: From admission to 2 months after surgery
Length of stay for hospitalization
Length of stay for hospitalization after mastectomy and breast reconstruction. Time is counted from admission to hospital discharged.
Measured: At Discharge (up to 30 days)
Readmission rates
Readmission rates to the hospital within 6 months after mastectomy and breast reconstruction.
Measured: 6 months after mastectomy and breast reconstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study startNov 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJun 2020 (estimated)
Why it stopped: Lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doug Jaffe, DO, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03388814
- Sponsor's protocol ID
- IRB00047335
- Status last verified
- Nov 2018
- First submitted
- 19 Dec 2017
- Last updated
- 30 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speeding Recovery From Pain and Opioid Use After Mastectomy and Breast Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT03388814
- Acronym / sponsor ID
- IRB00047335
- Conditions
- Pain, Postoperative, Breast Cancer, Opioid Use, Surgery
- Keywords
- PPBCS, Acute, Postoperative, Mastectomy, Breast Reconstruction
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 3 Jan 2018 (actual)
- 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.
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. However, breast reconstruction at the same time as mastectomy has been linked to higher postoperative pain, which can be a risk factor for persistent pain. The goal of this study is to determine the speed of recovery from pain and opioid use in the first 2 months after breast surgery and reconstruction.
Detailed description
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living. Surgical treatments can also negatively influence social exposure and alter self-perception and sexual health. Reconstruction of the breast mound following mastectomy has several benefits in psychosocial functioning, body image and satisfaction with breast appearance, and sexual well-being. However, reconstruction at the same time as mastectomy has been linked to higher postoperative pain. Compared to autologous breast reconstruction, implant based techniques have been linked to higher requirements of postoperative nonsteroidal anti-inflammatory drugs, opioids, and benzodiazepines as well as higher pain scores in the immediate postoperative period and one year after surgery. Recent publications report that intensity of pain in the operative area prior to surgery, body mass index (BMI), presence of axillary operation, intensity of acute postoperative pain, and amount of opioid required to achieve satisfactory analgesia in the acute postoperative period are also risk factors for persistent pain following breast cancer surgery (PPBCS). Since severity of acute postoperative pain is consistently observed as a risk factor for persistent pain, there has been interest in determining whether better acute pain control reduces this risk. Infiltration of the surgical site with bupivacaine decreases intraoperative and postoperative narcotic use, and has been associated with decreased pain scores in the immediate postoperative period. A novel approach to hemithoracic analgesia has been introduced which proposed less risk of anatomic trespass by doing a local anesthetic injection into the fascial planes of the chest wall. These procedures have demonstrated improved analgesia for breast surgeries. Unfortunately, there is a lack of large, multicenter, prospective, and randomized trials comparing these analgesic modalities and evaluating the response to these acute postoperative analgesic interventions with regard to PPBCS and other metrics of daily function, satisfaction with pain control, and self-perception of well-being and predictors of recovery from the pain state. The goals of this research are to provide short-term surrogate measures for prevention or treatment trials and to develop methods enabling practitioners to forecast recovery in real-time and that are translatable to patients in understandable references regarding risk over time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Group | Active comparator | Drug: Local infiltration of bupivacaineThose patients randomized to surgeon infiltration will have a skin wheal performed with lidocaine at the site where an actual pectoralis nerve block would be performed as visualized using ultrasound. Surgeons performing infiltration techniques will be blinded to the contents of the injectate and those patients randomized to surgeon infiltration will receive pharmacy study drug labeled bupivacaine injected in the same fashion and volume as the saline group for oncologic and plastic surgery. |
| Pectoralis Nerve block Group | Experimental | Drug: Pectoralis Nerve blockThose patients who are randomized to pectoralis nerve block will have randomization immediately preoperatively and will undergo the nerve block procedure using local anesthetic in the standard fashion. Those patients randomized to pectoralis block will have a standard volume of normal saline injected for oncologic and plastic surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for unilateral mastectomy with immediate issue expander and implant based reconstruction.
- Age ≥ 18 years
- Ability to understand, read, and write English, and the willingness to sign an IRB-approved informed consent document.
- Patients who receive a tissue expander placement will be included in the study.
- American Society of Anesthesiologists physical status I-III patients.
Key exclusion criteria (9 listed)
- Patients who receive an autologous tissue reconstruction.
- Patients who receive a bilateral reconstruction.
- Patients who receive a direct to permanent implant reconstruction
- Patients with diagnosis of opioid misuse disorder or on high dose opioid therapy (greater than 100 mg equivalents of oral morphine per day)
- Patients who are wards of the state
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 |
|---|---|---|
| Local infiltration of bupivacainePatients assigned to the local infiltration with bupivacaine group will receive 30 ml of 0.25% bupivacaine with 1:200,000 epinephrine. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. The local anesthetic will be injected into the chest wall and skin flaps. Attending physicians and resident physicians will receive prior instruction regarding correct placement of the local anesthetic so that it will be consistently placed in the same locations with similar volume distribution. | Drug | Bupivacaine Group |
| Pectoralis Nerve blockPatients assigned to the pectoralis block group will receive a total of 20 ml 0.25% bupivacaine (with 1:200,000 epinephrine and 1.67 mcg clonidine per ml) in the tissue plane between the serratus anterior and the pectoralis minor muscles at approximately the level of the 4th rib and 10 ml of the same solution in the tissue plane between the two pectoralis muscles at approximately the 3rd rib under ultrasound guidance on the surgical side preoperatively. | Drug | Pectoralis Nerve block Group |
Primary outcome
Modeled worst pain intensity using the numeric rating scale (NRS)
Time frame: From study start to 2 months after surgery
NRS pain scores will be obtained daily from time of initiation into the study until 2 months after surgery and the scores following hospital discharge will be modeled for each individual using a growth curve change-point approach. The NRS has a 0-10 numeric rating scale (0=no pain and 10=worst pain imaginable), where lower scores denotes better outcomes.
4 secondary outcomes
Area under the curve of the numeric rating scale (NRS)
Time frame: During the first 48 hours postoperatively
Opioid use
Time frame: From admission to 2 months after surgery
Length of stay for hospitalization
Time frame: At Discharge (up to 30 days)
Readmission rates
Time frame: 6 months after mastectomy and breast reconstruction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2018.
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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.
Doug Jaffe, DO principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Local infiltration of bupivacaine and Pectoralis Nerve block in people with Pain, Postoperative and Breast Cancer, run by Wake Forest University Health Sciences.
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 5 inclusion and 9 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: withdrawn, as of the sponsor's last update on 30 Nov 2018. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modeled worst pain intensity using the numeric rating scale (NRS) (time frame: From study start to 2 months after surgery). 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 30 Nov 2018.