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The addition of dexamethasone to non-liposomal bupivacaine in perineural blocks has been shown to enhance pain control and prolong the time until first request for postoperative narcotics in the fields of orthopedic, thoracic, and gynecologic surgery. This has not been investigated in any types of breast surgery. The investigators assessed if the combination of dexamethasone to bupivacaine in the preoperative field block prior to bilateral breast reduction surgery resulted in improved pain control relative to bupivacaine alone.
The investigators conducted a double-blind randomized controlled trial to determine whether the addition of dexamethasone to bupivacaine in a preoperative Pecs II block resulted in improved pain control, relative to bupivacaine alone, in patients undergoing bilateral reduction mammaplasty.
Using a preassigned randomization list, patients were randomized to experimental and control groups in a ratio of 1:1 upon enrollment. Both groups received PECS II bupivacaine field blocks in the preoperative holding area, performed by an acute pain fellowship-trained anesthesiologist. The experimental group received 29mL of 0.5% bupivacaine mixed with 1mL 4mg/mL dexamethasone per side. The control group received 29mL 0.5% bupivacaine mixed with 1mL 0.9 saline solution per side. To maintain the blinded aspect of the study, the anesthesiologists were given pre-mixed vials labelled uniformly for the trial, regardless of the patient's treatment arm.
The patients all underwent bilateral breast reduction with a single surgeon. Postoperative pain regimens were standardized. Subjective pain scores, narcotic consumption, 4-hour interval vital signs, anti-emetic usage, and postoperative quality of life via an sf-36 questionnaire were all recorded per patient.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
|
| Experimental | Experimental | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone 4mg | Drug | The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Initial Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
| 4-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 8-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 12-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 16-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 20-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
| Measure | Description | Time Frame |
|---|---|---|
| Initial Blood Pressure | Systolic blood pressure | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
| 4-hour Blood Pressure | Systolic blood pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew A Gassman, MD, FACS | Lewis Katz School of Medicine at Temple University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 27043853 | Background | Broyles JM, Tuffaha SH, Williams EH, Glickman L, George TA, Lee Dellon A. Pain after breast surgery: Etiology, diagnosis, and definitive management. Microsurgery. 2016 Oct;36(7):535-538. doi: 10.1002/micr.30055. Epub 2016 Apr 4. |
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De-identified data will be made available to other researchers if necessary
6 months after any potential publications from this study
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| FG001 | Experimental | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hospitalization and Wound Follow-up |
|
| ||||||||||||||||||
| SF-36 Quality of Life Survey Completion |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Initial Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Posted | Mean | Standard Deviation | score on a scale | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
|
2 months postoperatively
Other adverse event: wound complications of any severity
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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 | Control | Control group patients received 29mL bupivacaine plus 1mL 0.9% saline. Like the experimental group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound complications | Surgical and medical procedures | Systematic Assessment | Assessment of wound complications during any postoperative clinic visit |
Single-center study, which may limit the generalizability of the results The patient population is predominantly composed of racial minority communities, which may also limit the generalizability to many institutions Low SF-36 completion limited an adequate determination of the effects of the block on quality of life metrics. Some SF-36 questionnaires were completed by phone interview The COVID-19 pandemic halted enrollment for four months, which may have imposed a selection bias
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| George Taylor, MD, MS; surgical resident | Temple University Hospital | 2678150512 | George.Taylor@tuhs.temple.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 16, 2017 | May 20, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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Double-blinded randomized controlled trial. Subjects were randomized 1:1 to the experimental or control groups. Each patient received the same Pecs II perineural block preoperatively with the same volume injected. Experimental group patients received 29mL 0.5% bupivacaine with 1mL of 4mg/mL dexamethasone, while control group patients received 29mL 0.5% bupivacaine with 1mL of 0.9% saline.
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The surgeon (investigator), patient, and anesthesiologists were not aware of which arm each participant was assigned to. Furthermore, each injected analgesic was premixed and uniformly labeled to maintain blinding.
| Saline | Drug | The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty. |
|
| 24-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
| Narcotic Consumption | Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization | Up to 24 hours postoperatively |
| Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 8-hour Blood Pressure | Systolic blood pressure | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 12-hour Blood Pressure | Systolic blood pressure | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 16-hour Blood Pressure | Systolic blood pressure | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 20-hour Blood Pressure | Systolic blood pressure | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 24-hour Blood Pressure | Systolic blood pressure | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
| Initial Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
| 4-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 8-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 12-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 16-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 20-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
| 24-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
| Number of Patients Administered Anti-emetics at 4-hour Intervals | Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals | Initial, 4, 8, 12, 16, 20, and 24 hours |
| Short-form 36-item (Sf-36) Quality of Life Questionnaire | Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category. | 1 week to 2 months postoperatively |
| Rate of Wound Complications | Assessment of wound complications during any postoperative clinic visit | 1 week to 2 months postoperatively |
| 31741068 | Background | Ahiskalioglu A, Yayik AM, Demir U, Ahiskalioglu EO, Celik EC, Ekinci M, Celik M, Cinal H, Tan O, Aydin ME. Preemptive Analgesic Efficacy of the Ultrasound-Guided Bilateral Superficial Serratus Plane Block on Postoperative Pain in Breast Reduction Surgery: A Prospective Randomized Controlled Study. Aesthetic Plast Surg. 2020 Feb;44(1):37-44. doi: 10.1007/s00266-019-01542-y. Epub 2019 Nov 18. |
| 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. |
| 31303703 | Background | Vetriselvan P, Mandal B, Bhatia N, Jain V. Effect of dexamethasone on analgesic efficacy of transverse abdominis plane block in laparoscopic gynecological procedures: A prospective randomized clinical study. J Anaesthesiol Clin Pharmacol. 2019 Apr-Jun;35(2):165-169. doi: 10.4103/joacp.JOACP_374_17. |
| 27473629 | Background | Maher DP, Serna-Gallegos D, Mardirosian R, Thomas OJ, Zhang X, McKenna R, Yumul R, Zhang V. The Combination of IV and Perineural Dexamethasone Prolongs the Analgesic Duration of Intercostal Nerve Blocks Compared with IV Dexamethasone Alone. Pain Med. 2017 Jun 1;18(6):1152-1160. doi: 10.1093/pm/pnw149. |
| 28033159 | Background | Bjorn S, Linde F, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. Effect of Perineural Dexamethasone on the Duration of Single Injection Saphenous Nerve Block for Analgesia After Major Ankle Surgery: A Randomized, Controlled Study. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):210-216. doi: 10.1097/AAP.0000000000000538. |
| 30066465 | Background | Ibrahim AS, Aly MG, Farrag WS, Gad El-Rab NA, Said HG, Saad AH. Ultrasound-guided adductor canal block after arthroscopic anterior cruciate ligament reconstruction: Effect of adding dexamethasone to bupivacaine, a randomized controlled trial. Eur J Pain. 2019 Jan;23(1):135-141. doi: 10.1002/ejp.1292. Epub 2018 Aug 6. |
| NOT COMPLETED |
|
|
| BG001 | Experimental | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Anemia | Count of Participants | Participants |
|
| Anxiety | Count of Participants | Participants |
|
| Asthma | Count of Participants | Participants |
|
| Depression | Count of Participants | Participants |
|
| Degenerative Disc Disease | Count of Participants | Participants |
|
| Degenerative Joint Disease | Count of Participants | Participants |
|
| Diabetes | Count of Participants | Participants |
|
| Drug Abuse | Count of Participants | Participants |
|
| Gastroesophaageal reflux disease (GERD) | Count of Participants | Participants |
|
| Hypothyroidism | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Human immunodeficiency virus infection (HIV) / Acquired immunodeficiency syndrome AIDS | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Insomnia | Count of Participants | Participants |
|
| Migraines | Count of Participants | Participants |
|
| Polycystic ovaries | Count of Participants | Participants |
|
| Uterine Fibroids | Count of Participants | Participants |
|
| Abnormal Uterine Bleeding | Count of Participants | Participants |
|
| Rheumatoid Arthritis | Count of Participants | Participants |
|
Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick.
|
|
| Primary | 4-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Posted | Mean | Standard Deviation | score on a scale | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Primary | 8-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Posted | Mean | Standard Deviation | score on a scale | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Primary | 12-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Between the prior time point and this time point, 8 patients from the experimental group had been discharged to home | Posted | Mean | Standard Deviation | score on a scale | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Primary | 16-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Between the prior time point and this time point, 9 patients in the control group and 2 patients from the experimental group had been discharged to home | Posted | Mean | Standard Deviation | score on a scale | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Primary | 20-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Between the prior time point and this time point, 7 patients in the control group and 4 patients from the experimental group had been discharged to home | Posted | Mean | Standard Deviation | score on a scale | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Primary | 24-hour Visual Analog Scale (VAS) Pain Scores | Patient-reported pain scores on a scale of 1-10 (1 is low or no pain and 10 is the highest amount of pain) | Between the prior time point and this time point, 4 patients in the control group and 6 patients from the experimental group had been discharged to home | Posted | Mean | Standard Deviation | score on a scale | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Primary | Narcotic Consumption | Mean narcotics used by each patient while in the hospital during the 24-hour hospitalization | Posted | Mean | Standard Deviation | Oral Morphine Equivalents (OME) | Up to 24 hours postoperatively |
|
|
|
| Secondary | Initial Blood Pressure | Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 4-hour Blood Pressure | Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 8-hour Blood Pressure | Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 12-hour Blood Pressure | Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 16-hour Blood Pressure | Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 20-hour Blood Pressure | Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 24-hour Blood Pressure | Systolic blood pressure | Posted | Mean | Standard Deviation | mmHg | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | Initial Oxygen Saturation | SpO2 as measured by pulse oximetry | Posted | Mean | Standard Deviation | percentage of blood oxygen saturation | Recorded immediately upon arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 4-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Posted | Mean | Standard Deviation | percentage of blood oxygen saturation | Recorded at 4-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 8-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Posted | Mean | Standard Deviation | percentage of blood oxygen saturation | Recorded at 8-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 12-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Posted | Mean | Standard Deviation | percentage of blood oxygen saturation | Recorded at 12-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 16-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Posted | Mean | Standard Deviation | percentage of blood oxygen saturation | Recorded at 16-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 20-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Posted | Mean | Standard Deviation | percentage of blood oxygen saturation | Recorded at 20-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | 24-hour Oxygen Saturation | SpO2 as measured by pulse oximetry | Posted | Mean | Standard Deviation | percentage of blood oxygen saturation | Recorded at 24-hours after arrival to the post-anesthesia recovery unit (PACU) |
|
|
|
| Secondary | Number of Patients Administered Anti-emetics at 4-hour Intervals | Frequency of anti-emetics administered for complaints of nausea or vomiting at 4-hour intervals | Posted | Count of Participants | Participants | Initial, 4, 8, 12, 16, 20, and 24 hours |
|
|
|
| Secondary | Short-form 36-item (Sf-36) Quality of Life Questionnaire | Aggregate results of the sf-36 quality of life assessment. This was provided one time to each patient, as early as at the first postoperative visit or at any time thereafter up to 2 months postoperatively. This assessment has been validated to measure 8 categories related to quality of life: physical functioning, limitations due to physical health, limitations due to emotional health, perceived level of energy/fatigue, emotional well-being, social functioning, pain, and overall general health. The responses to the 36 questions are tabulated and each category is given a score from 1-100 for each individual patient. Higher scores indicate a better quality of life for that category. The rows/data below report the mean and standard deviations of the collected scores in each category. | Posted | Mean | Standard Deviation | score on a scale | 1 week to 2 months postoperatively |
|
|
|
| Secondary | Rate of Wound Complications | Assessment of wound complications during any postoperative clinic visit | Posted | Count of Participants | Participants | 1 week to 2 months postoperatively |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 7 |
| 26 |
| EG001 | Experimental | Experimental group patients received 29mL bupivacaine plus 1mL of 4mg/mL dexamethasone. Like the control group, 20mL of the mixture was injected into the fascial plane between the pectoralis minor and the serratus anterior muscles at the level of the third rib, while the remaining 10mL of the mixture was then injected into the fascial plane between the pectoralis major and pectoralis minor muscles during the same needlestick. | 0 | 25 | 0 | 25 | 8 | 25 |
|
Not provided
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| 8-hours postoperatively |
|
| 12-hours postoperatively |
|
| 16-hours postoperatively |
|
| 20-hours postoperatively |
|
| 24-hours postoperatively |
|
| Limitations Due to Emotional Health |
|
| Energy/Fatigue |
|
| Emotional Well-being |
|
| Social Functioning |
|
| Pain |
|
| Overall General Health |
|
| Moderate |
|
| Severe |
|