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The purpose of this study is to evaluate if a lidocaine infusion will provide benefit to pancreatectomy patients in regards to analgesia and return of bowel function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Active Comparator | lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. |
|
| Control group | Placebo Comparator | placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug |
| ||
| Placebo D5W |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Pain in Postoperative Period | Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | baseline - arrival at the PACU |
| Opioid Consumption | Total opioid consumption in PACU converted to morphine equivalents in mg. | up to 4 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Rest | Pain will be measured at rest upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | baseline - arrival at the PACU |
| Pain With Coughing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elird Bojaxhi, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13521304 | Background | DE CLIVE-LOWE SG, DESMOND J, NORTH J. Intravenous lignocaine anaesthesia. Anaesthesia. 1958 Apr;13(2):138-46. doi: 10.1111/j.1365-2044.1958.tb08045.x. No abstract available. | |
| 14448503 | Background | BARTLETT EE, HUTSERANI O. Xylocaine for the relief of postoperative pain. Anesth Analg. 1961 May-Jun;40:296-304. No abstract available. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group | lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine |
| FG001 | Control Group | placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine |
| BG001 | Control Group |
| 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 | Overall Pain in Postoperative Period | Overall pain will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | baseline - arrival at the PACU |
|
Adverse event data were collected from the time patient initiated study drug infusion until hospital discharge (approximately 5-7 days).
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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 | Treatment Group | lidocaine infusion will be initiated at the time of anesthesia induction in the operating room. Dosage 1.5mg/kg/hour. Continuous infusion until patient meets discharge criteria in recovery room. Lidocaine |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Elird Bojaxhi | Mayo Clinic | 904-956-3327 | bojaxhi.elrid@mayo.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 | Mar 30, 2016 | Mar 19, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
Pain with coughing will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. |
| baseline - arrival at the PACU |
| Overall Pain | Overall pain will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | 30 minutes after arrival to PACU |
| Pain at Rest | Pain at rest will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | 30 minutes after arrival to PACU |
| Pain With Coughing | Pain with coughing will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | 30 minutes after arrival to PACU |
| Overall Pain | Overall pain will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | approximately 12 hours post-operatively |
| Pain at Rest | Pain at rest will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | approximately 12 hours post-operatively |
| Pain With Coughing | Pain with coughing will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | approximately 12 hours post-operatively |
| Overall Pain | Overall pain will be measured on post-operative day 1 at 1am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | post-operative day 1 at 1am |
| Pain at Rest | Pain at rest will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | post-operative day 1 at 1 am |
| Pain With Coughing | Pain with coughing will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | post-operative day 1 at 1 am |
| Overall Pain | Overall pain will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | post-operative day 1 at 1 pm |
| Pain at Rest | Pain at rest will be measured at post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | post-operative day 1 at 1 pm |
| Pain With Coughing | Pain with coughing will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | post-operative day 1 at 1 pm |
| Length of Time to First Flatus | Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return. | up to 3 weeks postoperatively |
| Length of Time to First Bowel Movement | Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return. | up to 3 weeks postoperatively |
| Total Opioid Consumption | Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery. | up to 24 hours post-operatively |
| Quality of Recovery | This questionnaire is a short 15 question form that measures the quality of a subject's postoperative recovery. The scale is ranked from 0 to 10, where 0 is a poor response and 10 is an excellent response. | Day 15 post-operatively |
| 11091234 | Background | Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x. |
| 17197840 | Background | Kaba A, Laurent SR, Detroz BJ, Sessler DI, Durieux ME, Lamy ML, Joris JL. Intravenous lidocaine infusion facilitates acute rehabilitation after laparoscopic colectomy. Anesthesiology. 2007 Jan;106(1):11-8; discussion 5-6. doi: 10.1097/00000542-200701000-00007. |
| 3631561 | Background | Wallin G, Cassuto J, Hogstrom S, Linden I, Faxen A, Rimback G, Hedner T. Effects of lidocaine infusion on the sympathetic response to abdominal surgery. Anesth Analg. 1987 Oct;66(10):1008-13. |
| 11460813 | Background | Wheatley RG, Schug SA, Watson D. Safety and efficacy of postoperative epidural analgesia. Br J Anaesth. 2001 Jul;87(1):47-61. doi: 10.1093/bja/87.1.47. No abstract available. |
| 14515286 | Background | Senagore AJ, Delaney CP, Mekhail N, Dugan A, Fazio VW. Randomized clinical trial comparing epidural anaesthesia and patient-controlled analgesia after laparoscopic segmental colectomy. Br J Surg. 2003 Oct;90(10):1195-9. doi: 10.1002/bjs.4223. |
| 18844267 | Background | Marret E, Rolin M, Beaussier M, Bonnet F. Meta-analysis of intravenous lidocaine and postoperative recovery after abdominal surgery. Br J Surg. 2008 Nov;95(11):1331-8. doi: 10.1002/bjs.6375. |
| 17667496 | Background | Herroeder S, Pecher S, Schonherr ME, Kaulitz G, Hahnenkamp K, Friess H, Bottiger BW, Bauer H, Dijkgraaf MG, Durieux ME, Hollmann MW. Systemic lidocaine shortens length of hospital stay after colorectal surgery: a double-blinded, randomized, placebo-controlled trial. Ann Surg. 2007 Aug;246(2):192-200. doi: 10.1097/SLA.0b013e31805dac11. |
| 2316883 | Background | Rimback G, Cassuto J, Tollesson PO. Treatment of postoperative paralytic ileus by intravenous lidocaine infusion. Anesth Analg. 1990 Apr;70(4):414-9. |
| 12799407 | Background | Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983. |
| 22290456 | Background | Myles PS, Wengritzky R. Simplified postoperative nausea and vomiting impact scale for audit and post-discharge review. Br J Anaesth. 2012 Mar;108(3):423-9. doi: 10.1093/bja/aer505. Epub 2012 Jan 29. |
| 10740540 | Background | Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366. |
| 21621130 | Background | Hjermstad MJ, Fayers PM, Haugen DF, Caraceni A, Hanks GW, Loge JH, Fainsinger R, Aass N, Kaasa S; European Palliative Care Research Collaborative (EPCRC). Studies comparing Numerical Rating Scales, Verbal Rating Scales, and Visual Analogue Scales for assessment of pain intensity in adults: a systematic literature review. J Pain Symptom Manage. 2011 Jun;41(6):1073-93. doi: 10.1016/j.jpainsymman.2010.08.016. |
| 17061640 | Background | Gower ST, Quigg CA, Hunt JO, Wallace SK, Myles PS. A comparison of patient self-administered and investigator-administered measurement of quality of recovery using the QoR-40. Anaesth Intensive Care. 2006 Oct;34(5):634-8. doi: 10.1177/0310057X0603400514. |
| 10969322 | Background | Hollmann MW, Durieux ME. Local anesthetics and the inflammatory response: a new therapeutic indication? Anesthesiology. 2000 Sep;93(3):858-75. doi: 10.1097/00000542-200009000-00038. No abstract available. |
placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| American Society of Anesthesiologists (ASA) Physical Status Classification | Measure Description: ASA classification defines ASA I as a normal healthy patient, ASA II as a patient with a mild systemic disease without substantive functional limitations and an ASA III as a patient with a severe systemic disease with substantive functional limitations. A lower classification (I/II) is a more positive reflection of overall health compared to a higher classification (III). | Count of Participants | Participants |
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| Primary | Opioid Consumption | Total opioid consumption in PACU converted to morphine equivalents in mg. | Posted | Mean | Standard Deviation | mg | up to 4 hours post-operatively |
|
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|
|
| Secondary | Pain at Rest | Pain will be measured at rest upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | baseline - arrival at the PACU |
|
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|
|
| Secondary | Pain With Coughing | Pain with coughing will be measured upon arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | baseline - arrival at the PACU |
|
|
|
|
| Secondary | Overall Pain | Overall pain will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes after arrival to PACU |
|
|
|
|
| Secondary | Pain at Rest | Pain at rest will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes after arrival to PACU |
|
|
|
|
| Secondary | Pain With Coughing | Pain with coughing will be measured 30 minutes after arrival at the post-operative care unit (PACU) using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | 30 minutes after arrival to PACU |
|
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| Secondary | Overall Pain | Overall pain will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | approximately 12 hours post-operatively |
|
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|
|
| Secondary | Pain at Rest | Pain at rest will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | approximately 12 hours post-operatively |
|
|
|
|
| Secondary | Pain With Coughing | Pain with coughing will be measured approximately 12 hours post-operatively using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | approximately 12 hours post-operatively |
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|
| Secondary | Overall Pain | Overall pain will be measured on post-operative day 1 at 1am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | post-operative day 1 at 1am |
|
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|
| Secondary | Pain at Rest | Pain at rest will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | post-operative day 1 at 1 am |
|
|
|
|
| Secondary | Pain With Coughing | Pain with coughing will be measured on post-operative day 1 at 1 am using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | post-operative day 1 at 1 am |
|
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|
|
| Secondary | Overall Pain | Overall pain will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | post-operative day 1 at 1 pm |
|
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|
| Secondary | Pain at Rest | Pain at rest will be measured at post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | post-operative day 1 at 1 pm |
|
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|
|
| Secondary | Pain With Coughing | Pain with coughing will be measured on post-operative day 1 at 1 pm using numerical rating scale (NSR). Subjects will rate their pain after surgery on a scale from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable. | Posted | Mean | Standard Deviation | score on a scale | post-operative day 1 at 1 pm |
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| Secondary | Length of Time to First Flatus | Time of first instance of flatus will be measured as the number of days post operatively for bowel function to return. | Posted | Mean | Standard Deviation | days | up to 3 weeks postoperatively |
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| Secondary | Length of Time to First Bowel Movement | Time of first instance of a bowel movement will be measured as the number of days post operatively for bowel function to return. | Posted | Mean | Standard Deviation | days | up to 3 weeks postoperatively |
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| Secondary | Total Opioid Consumption | Total amount of opioids converted to morphine equivalents in mg administered in the first 24 hours after surgery. | Posted | Mean | Standard Deviation | mg | up to 24 hours post-operatively |
|
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| Secondary | Quality of Recovery | This questionnaire is a short 15 question form that measures the quality of a subject's postoperative recovery. The scale is ranked from 0 to 10, where 0 is a poor response and 10 is an excellent response. | Posted | Mean | Standard Deviation | score on a scale | Day 15 post-operatively |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Control Group | placebo infusion (D5W) will be initiated at the time of anesthesia induction in the operating room. Continuous infusion until patient meets discharge criteria in recovery room. Placebo D5W | 0 | 23 | 0 | 23 | 0 | 23 |
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| Aniline Compounds |
| D000588 | Amines |
| Feeling rested |
|
| Have had a good sleep |
|
| Able to look after personal toliet and hygiene |
|
| Able to communicate with family or friends |
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| Getting support from hospital doctors and nurse |
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| Able to return to work or usual home activities |
|
| Feeling comfortable and in control |
|
| Having a feeling of general well-being |
|
| Moderate pain |
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| Severe pain |
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| Nausea or vomiting |
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| Feeling worried or anxious |
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| Feeling sad or depressed |
|