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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEC I/II block - pre-operative | Active Comparator | 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 block - intra-operative | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEC I/II blocks by anesthesiologist - pre-operative | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | upon arrival to the recovery room after leaving the operating room |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 post surgery |
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Inclusion Criteria:
Exclusion Criteria:
Female patients with breast cancer scheduled to undergo mastectomy
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| Name | Affiliation | Role |
|---|---|---|
| Melinda Seering, MD | Univerisity of Iowa Hospital & Clinics | Principal Investigator |
| Ingrid Lizarraga, MD | Univerisity of Iowa Hospital & Clinics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52245 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25376971 | Background | Bashandy GM, Abbas DN. Pectoral nerves I and II blocks in multimodal analgesia for breast cancer surgery: a randomized clinical trial. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):68-74. doi: 10.1097/AAP.0000000000000163. | |
| 29227351 | Background | Kamiya Y, Hasegawa M, Yoshida T, Takamatsu M, Koyama Y. Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A randomised controlled trial. Eur J Anaesthesiol. 2018 Mar;35(3):215-223. doi: 10.1097/EJA.0000000000000762. |
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All of the individual participant data collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be available for sharing immediately after publication and ending 5 years following article publication.
IPD will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | upon arrival to the recovery room after leaving the operating room |
|
Information collection on adverse events were collected over the first 14 days post-operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Local Anesthetic Toxicity | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Surgical and medical procedures | Systematic Assessment |
Tools for measuring postoperative pain are subjective. Among the 23 patients who used the electronic reporting format, 58% of the POD 1-14 questionnaires were completed at least one day later, which raises the concern for recall bias. Secondly, our sample size was calculated to detect a difference in mean pain score of 2; however, given the relatively low mean pain scores encountered in our study, this might not be realistic to achieve.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melinda Seering, M.D. | University of Iowa Hospitals and Clinics | (319) 384-8466 | melinda-seering@uiowa.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 3, 2018 | Feb 14, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 3, 2018 | Feb 14, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 3, 2018 | May 1, 2023 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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RANDOMIZED CONTROLLED DOUBLE BLIND STUDY
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|
| PEC I/II blocks by surgeon - intra-operative | Procedure | 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). |
|
| 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. |
| Day 3 post surgery |
| 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. | Day 7 post surgery |
| 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. | Approximately day 14 post surgery |
| 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. | 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 |
| 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. | In-patient (from time patient arrives to in-patient unit from the recovery room until discharged home). Generally this was around 24 hours |
| 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. | Intra-operative (narcotics given during the operating room time) |
| 27543533 | Background | Kulhari S, Bharti N, Bala I, Arora S, Singh G. Efficacy of pectoral nerve block versus thoracic paravertebral block for postoperative analgesia after radical mastectomy: a randomized controlled trial. Br J Anaesth. 2016 Sep;117(3):382-6. doi: 10.1093/bja/aew223. |
| 28133848 | Background | Larsson IM, Ahm Sorensen J, Bille C. The Post-mastectomy Pain Syndrome-A Systematic Review of the Treatment Modalities. Breast J. 2017 May;23(3):338-343. doi: 10.1111/tbj.12739. Epub 2017 Jan 30. |
| 28195858 | Background | Ruscheweyh R, Viehoff A, Tio J, Pogatzki-Zahn EM. Psychophysical and psychological predictors of acute pain after breast surgery differ in patients with and without pre-existing chronic pain. Pain. 2017 Jun;158(6):1030-1038. doi: 10.1097/j.pain.0000000000000873. |
| 25494696 | Background | Schreiber KL, Kehlet H, Belfer I, Edwards RR. Predicting, preventing and managing persistent pain after breast cancer surgery: the importance of psychosocial factors. Pain Manag. 2014;4(6):445-59. doi: 10.2217/pmt.14.33. |
| 23290256 | Background | Schreiber KL, Martel MO, Shnol H, Shaffer JR, Greco C, Viray N, Taylor LN, McLaughlin M, Brufsky A, Ahrendt G, Bovbjerg D, Edwards RR, Belfer I. Persistent pain in postmastectomy patients: comparison of psychophysical, medical, surgical, and psychosocial characteristics between patients with and without pain. Pain. 2013 May;154(5):660-668. doi: 10.1016/j.pain.2012.11.015. Epub 2012 Dec 5. |
| 18453290 | Background | Vadivelu N, Schreck M, Lopez J, Kodumudi G, Narayan D. Pain after mastectomy and breast reconstruction. Am Surg. 2008 Apr;74(4):285-96. |
| 18682712 | Background | Vilholm OJ, Cold S, Rasmussen L, Sindrup SH. The postmastectomy pain syndrome: an epidemiological study on the prevalence of chronic pain after surgery for breast cancer. Br J Cancer. 2008 Aug 19;99(4):604-10. doi: 10.1038/sj.bjc.6604534. |
| 8880841 | Background | Wallace MS, Wallace AM, Lee J, Dobke MK. Pain after breast surgery: a survey of 282 women. Pain. 1996 Aug;66(2-3):195-205. doi: 10.1016/0304-3959(96)03064-3. |
| 27402075 | Background | Wang L, Guyatt GH, Kennedy SA, Romerosa B, Kwon HY, Kaushal A, Chang Y, Craigie S, de Almeida CPB, Couban RJ, Parascandalo SR, Izhar Z, Reid S, Khan JS, McGillion M, Busse JW. Predictors of persistent pain after breast cancer surgery: a systematic review and meta-analysis of observational studies. CMAJ. 2016 Oct 4;188(14):E352-E361. doi: 10.1503/cmaj.151276. Epub 2016 Jul 11. |
| 22939099 | Background | Blanco R, Fajardo M, Parras Maldonado T. Ultrasound description of Pecs II (modified Pecs I): a novel approach to breast surgery. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):470-5. doi: 10.1016/j.redar.2012.07.003. Epub 2012 Aug 29. |
| 16931684 | Background | Kairaluoma PM, Bachmann MS, Rosenberg PH, Pere PJ. Preincisional paravertebral block reduces the prevalence of chronic pain after breast surgery. Anesth Analg. 2006 Sep;103(3):703-8. doi: 10.1213/01.ane.0000230603.92574.4e. |
| 19903919 | Background | Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. |
| 22588748 | Background | Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available. |
| 37526752 | Derived | Lizarraga IM, Huang K, Yalamuru B, Mott SL, Sibenaller ZA, Keith JN, Sugg SL, Erdahl LM, Seering M. A Randomized Single-Blinded Study Comparing Preoperative with Post-Mastectomy PECS Block for Post-operative Pain Management in Bilateral Mastectomy with Immediate Reconstruction. Ann Surg Oncol. 2023 Oct;30(10):6010-6021. doi: 10.1245/s10434-023-13890-w. Epub 2023 Aug 1. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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). |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Day 1 post surgery |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Day 3 post surgery |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Day 7 post surgery |
|
|
|
| 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. | Posted | Mean | 90% Confidence Interval | units on a scale | Approximately day 14 post surgery |
|
|
|
| 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. | Posted | Median | 97.5% Confidence Interval | Morphine Milligram Equivalents | 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 |
|
|
|
| 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. | Posted | Median | 70% Confidence Interval | Morphine Milligram Equivalents | In-patient (from time patient arrives to in-patient unit from the recovery room until discharged home). Generally this was around 24 hours |
|
|
|
| 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. | Posted | Median | 99% Confidence Interval | Morphine Milligram Equivalents | Intra-operative (narcotics given during the operating room time) |
|
|
|
| 17 |
| 17 |
| 0 |
| 17 |
| 6 |
| 17 |
| EG001 | 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 | 17 | 0 | 17 | 3 | 17 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |