Anesthesia, Breast Cancer, Nerve Block, Postoperative Pain
Conditions
Keywords
Nerve block, Pectoralis nerve blocks, PECS I, PECS II, Mastectomy
Brief summary
The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after mastectomy.
Detailed description
The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction cases. The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after the mastectomy. Patients undergoing mastectomies at the University of Iowa Hospitals clinics receive general anesthesia and a regional block for pain control. The most commonly employed regional anesthetic technique is a PECS I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PECS I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PECS II). The investigators will randomize patients into two groups and blind the patient and the research assistant collecting the data. Group I will have the block performed after induction of general anesthesia and prior to surgical incision by the anesthesiologist. Group II will have the block administered by the surgeon after mastectomy is performed and before reconstruction. On the day of surgery, the investigators will have patients fill out forms to measure pain catastrophizing and depression and anxiety. The investigators would like to measure if there is any difference in postoperative pain scores (visual analogue scale)-immediately post surgery in post-anesthesia care unit (PACU), and then on the admission unit every 4 hours for the first twenty four hours or on discharge (whichever time-point occurs sooner) and will collect the average pain scale of the day on post-op day (POD) 2,3,5 and 7 via patient communication electronic message in RedCap. The investigators will also measure intraoperative and post-operative narcotic use (converted to morphine equivalents), post-operative nausea and vomiting, length of (PACU) stay. In addition the investigators will also collect pain scores and pain catastrophic scale on POD 14 after surgery at their clinic visits to the surgeon. Other data collected will include time taken to perform block, post-operative infection rate and post-operative flap necrosis rate.
Interventions
PROCEDUREPEC I/II blocks by anesthesiologist - pre-operative
PEC I/II blocks by anesthesiologist - pre-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II). Group I will have the PEC block administered by the anesthesiologist prior to surgical incision.
PROCEDUREPEC I/II blocks by surgeon - intra-operative
PEC I/II blocks by surgeon - intra-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II).
Sponsors
Melinda Seering
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
RANDOMIZED CONTROLLED DOUBLE BLIND STUDY
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Female * Bilateral mastectomy for breast cancer * Undergoing breast reconstruction * Must weigh at least 50 kg
Exclusion criteria
* More than 80 years of age * Male * Prisoners * Patients who can't provide their own consent * Lumpectomy only patients * Patients having prophylactic mastectomies * Patient must weigh at least 50 kg * Allergies to local anesthetics * Patient refusal * Patients with a history of bleeding disorders * Non-English speaking patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Assessment Using a Visual Analog Scale-Immediately Post-surgery | upon arrival to the recovery room after leaving the operating room | The primary outcome to be assessed is to determine if there is a quantitative difference in post-operative pain scores as a result of the administration of a pre-operative PECS I/II block versus the administration of an intra-operative PECS I/II block (Post mastectomy but prior to breast reconstruction). The visual analog scale is a unidimensional measure of pain used in a diverse adult population. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Score Assessment-Post-operative Day 3 | Day 3 post surgery | Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. |
| Pain Score Assessment-Post-operative Day 7 | Day 7 post surgery | Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. |
| Pain Score Assessment Using a Visual Analog Scale-Post-operative Surgical Recheck. | Approximately day 14 post surgery | When the patient returns to visit with their surgeon approximately 14 days after their surgical procedure, using the visual analog scale the subjects will report their average pain score. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. |
| Pain Score Assessment-Post-operative Day 1 | Day 1 post surgery | Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain. |
| Measure the Amount of Narcotics Use to Control Pain (In-patient) | In-patient (from time patient arrives to in-patient unit from the recovery room until discharged home). Generally this was around 24 hours | The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects. |
| Measure the Amount of Narcotics Use to Control Pain (Intra-op) | Intra-operative (narcotics given during the operating room time) | The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects. |
| Measure the Amount of Narcotics Use to Control Pain. | PACU (from time patient left operating room until patient is discharged from the recovery area to in-patient unit). The time limit for this is generally 60-90 minutes | The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PEC I/II Block - Pre-operative The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction case. The intervention administered to Group I will having the block performed by the anesthesiologist after induction of general anesthesia and prior to surgical incision.
PEC I/II blocks by anesthesiologist - pre-operative: PEC I/II blocks by anesthesiologist - pre-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II). Group I will have the PEC block administered by the anesthesiologist prior to surgical incision. | 17 |
| PEC I/II Block - Intra-operative The current standard of care at the University of Iowa is to receive a pectoralis nerve block (PEC I/II) prior to surgery for mastectomy and reconstruction cases. Group II will have the block administered by the surgeon after mastectomy is performed and before reconstruction.
PEC I/II blocks by surgeon - intra-operative: PEC I/II blocks by surgeon - intra-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II). | 17 |
| Total | 34 |
Baseline characteristics
| Characteristic | PEC I/II Block - Intra-operative | Total | PEC I/II Block - Pre-operative |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 2 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 32 Participants | 16 Participants |
| Age, Continuous | 44 years | 44 years | 44 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 32 Participants | 17 Participants |
| Region of Enrollment United States | 17 participants | 34 participants | 17 participants |
| Sex: Female, Male Female | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 17 / 17 | 17 / 17 |
| other Total, other adverse events | 6 / 17 | 3 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
Primary
Pain Score Assessment Using a Visual Analog Scale-Immediately Post-surgery
The primary outcome to be assessed is to determine if there is a quantitative difference in post-operative pain scores as a result of the administration of a pre-operative PECS I/II block versus the administration of an intra-operative PECS I/II block (Post mastectomy but prior to breast reconstruction). The visual analog scale is a unidimensional measure of pain used in a diverse adult population. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain.
Time frame: upon arrival to the recovery room after leaving the operating room
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PEC I/II Block - Pre-operative | Pain Score Assessment Using a Visual Analog Scale-Immediately Post-surgery | 1.6 units on a scale |
| PEC I/II Block - Intra-operative | Pain Score Assessment Using a Visual Analog Scale-Immediately Post-surgery | 2.3 units on a scale |
Secondary
Measure the Amount of Narcotics Use to Control Pain.
The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects.
Time frame: PACU (from time patient left operating room until patient is discharged from the recovery area to in-patient unit). The time limit for this is generally 60-90 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEC I/II Block - Pre-operative | Measure the Amount of Narcotics Use to Control Pain. | 7.5 Morphine Milligram Equivalents |
| PEC I/II Block - Intra-operative | Measure the Amount of Narcotics Use to Control Pain. | 8.0 Morphine Milligram Equivalents |
Secondary
Measure the Amount of Narcotics Use to Control Pain (In-patient)
The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects.
Time frame: In-patient (from time patient arrives to in-patient unit from the recovery room until discharged home). Generally this was around 24 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEC I/II Block - Pre-operative | Measure the Amount of Narcotics Use to Control Pain (In-patient) | 30 Morphine Milligram Equivalents |
| PEC I/II Block - Intra-operative | Measure the Amount of Narcotics Use to Control Pain (In-patient) | 25.5 Morphine Milligram Equivalents |
Secondary
Measure the Amount of Narcotics Use to Control Pain (Intra-op)
The investigators will report the amount of narcotics required (converted to morphine units) to provide pain relief to subjects.
Time frame: Intra-operative (narcotics given during the operating room time)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PEC I/II Block - Pre-operative | Measure the Amount of Narcotics Use to Control Pain (Intra-op) | 42 Morphine Milligram Equivalents |
| PEC I/II Block - Intra-operative | Measure the Amount of Narcotics Use to Control Pain (Intra-op) | 42.4 Morphine Milligram Equivalents |
Secondary
Pain Score Assessment-Post-operative Day 1
Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain.
Time frame: Day 1 post surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PEC I/II Block - Pre-operative | Pain Score Assessment-Post-operative Day 1 | 3.1 units on a scale |
| PEC I/II Block - Intra-operative | Pain Score Assessment-Post-operative Day 1 | 2.7 units on a scale |
Secondary
Pain Score Assessment-Post-operative Day 3
Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain.
Time frame: Day 3 post surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PEC I/II Block - Pre-operative | Pain Score Assessment-Post-operative Day 3 | 2.5 units on a scale |
| PEC I/II Block - Intra-operative | Pain Score Assessment-Post-operative Day 3 | 2.1 units on a scale |
Secondary
Pain Score Assessment-Post-operative Day 7
Using electronic patient communications, the investigators will ask patients to report their average pain using a numeric values. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain.
Time frame: Day 7 post surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PEC I/II Block - Pre-operative | Pain Score Assessment-Post-operative Day 7 | 1.8 units on a scale |
| PEC I/II Block - Intra-operative | Pain Score Assessment-Post-operative Day 7 | 1.9 units on a scale |
Secondary
Pain Score Assessment Using a Visual Analog Scale-Post-operative Surgical Recheck.
When the patient returns to visit with their surgeon approximately 14 days after their surgical procedure, using the visual analog scale the subjects will report their average pain score. The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 as intense pain.
Time frame: Approximately day 14 post surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PEC I/II Block - Pre-operative | Pain Score Assessment Using a Visual Analog Scale-Post-operative Surgical Recheck. | 1.7 units on a scale |
| PEC I/II Block - Intra-operative | Pain Score Assessment Using a Visual Analog Scale-Post-operative Surgical Recheck. | 1.2 units on a scale |