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This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine 1.3% | Experimental | 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block |
|
| Bupivacaine 0.5% with Adjuncts | Active Comparator | 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivicaine 1.3% | Drug | 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block |
| Measure | Description | Time Frame |
|---|---|---|
| Total Opioid Consumption | Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs) | Up to 120 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Opioid Medication | From block time to the first dose of opioids given, measured in hours. | from the time of the block injection until discharge, assessed up to 72 postoperative hours. |
| Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total Amount of Opioid Consumed During the Indicated Time Periods | Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours. | 0-24, 24-48, 48-72, and 72-120 postoperative hours. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Finkel, MD | Hartford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Bone and Joint Institute at Hartford Hospital | Hartford | Connecticut | 06102 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28403427 | Background | Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. | |
| 20009936 | Background | Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine 1.3% | 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block |
| FG001 | Bupivacaine 0.5% With Adjuncts | 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Preoperative-48 Hours Postoperative |
|
| ||||||||||||||||||
| 48-96 Hours Postoperative |
| |||||||||||||||||||
| 60 Postoperative Days |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine 1.3% | 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block |
| BG001 | Bupivacaine 0.5% With Adjuncts |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Total Opioid Consumption | Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs) | 3 patients withdrew from Bupivacaine 0.5% with Adjuncts group. | Posted | Median | Inter-Quartile Range | MME | Up to 120 postoperative hours |
|
Adverse events were collected up to 60 postoperative 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 | Liposomal Bupivacaine 1.3% | 10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Rash around the block site |
Opioid consumption was subjected to patient recall and reporting bias. Patients were advised by surgery clinics to limit opioid intake postoperatively, which might indirectly limit opioid use and made it more difficult to show a difference. The study was double-blinded, the anesthesiologists who performed the block, were unblinded due to the difference in the physical appearance of the study drugs.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kevin Finkel | Hartford Hospital | 860-972-1778 | Kevin.Finkel@hhchealth.org |
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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 | Sep 2, 2022 | Mar 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2021 | Mar 13, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D004837 | Epinephrine |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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single-center, prospective, randomized controlled cross-sectional study
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| Bupivacaine 0.5% | Drug | 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block |
|
|
Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain. |
| 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60 |
| Hospital Length-of-stay | From the date and time of admission to the date and time of discharge, Measured in hours. | From the date of admission until discharge, assessed up to 72 hours. |
| Assessment of Patient Overall Satisfaction With Pain Control | Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate. | POD4 - 60 days |
| Incidence of Distress From Block Numbness | On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day. | At PACU and Postoperative day 2 |
| Duration of Sensory Nerve Block | Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60. | Day 1, after Day 1 (day 2 to 60), and at postoperative day 60 |
| Day of the Final Opioids Used | The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours. | 0-96 postoperative hours |
| Motor Recovery | The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5): 0= No detectable muscle contraction (visible or palpation)
The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data. | PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60. |
| 16368840 | Background | Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a. |
| 20814282 | Background | Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6. doi: 10.1097/AAP.0b013e3181e85eb9. |
| 23755801 | Background | Rasmussen SB, Saied NN, Bowens C Jr, Mercaldo ND, Schildcrout JS, Malchow RJ. Duration of upper and lower extremity peripheral nerve blockade is prolonged with dexamethasone when added to ropivacaine: a retrospective database analysis. Pain Med. 2013 Aug;14(8):1239-47. doi: 10.1111/pme.12150. Epub 2013 Jun 11. |
| 29305103 | Background | McLaughlin DC, Cheah JW, Aleshi P, Zhang AL, Ma CB, Feeley BT. Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. J Shoulder Elbow Surg. 2018 Apr;27(4):686-691. doi: 10.1016/j.jse.2017.11.015. Epub 2018 Jan 3. |
| 22956491 | Background | Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):19S-26S. doi: 10.1002/j.1875-9114.2012.01183.x. |
| 28479257 | Background | Abildgaard JT, Lonergan KT, Tolan SJ, Kissenberth MJ, Hawkins RJ, Washburn R 3rd, Adams KJ, Long CD, Shealy EC, Motley JR, Tokish JM. Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2017 Jul;26(7):1175-1181. doi: 10.1016/j.jse.2017.03.012. Epub 2017 May 4. |
| 28005096 | Background | Hannan CV, Albrecht MJ, Petersen SA, Srikumaran U. Liposomal Bupivacaine vs Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Retrospective Cohort Analysis. Am J Orthop (Belle Mead NJ). 2016 Nov/Dec;45(7):424-430. |
| 28843463 | Background | Wang K, Zhang HX. Liposomal bupivacaine versus interscalene nerve block for pain control after total shoulder arthroplasty: A systematic review and meta-analysis. Int J Surg. 2017 Oct;46:61-70. doi: 10.1016/j.ijsu.2017.08.569. Epub 2017 Aug 24. |
| 26117072 | Background | Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3. |
| 28157791 | Background | Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560. |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
|
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
| 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) | Median | Inter-Quartile Range | kg/m^2 |
|
| ASA Physical Status Classification | American Society of Anesthesiologists (ASA) physical status classification. ASA scale ranges (1-6), where 1 is the best while 6 is the worst ASA I = A normal healthy patient ASA II = A patient with mild systemic disease ASA III = A patient with severe systemic disease ASA IV = A patient with severe systemic disease that is a constant threat to life ASA V = A moribund patient who is not expected to survive without the operation ASA VI = A declared brain-dead patient whose organs are being removed for donor purposes | Median | Inter-Quartile Range | units on a scale |
|
| Preoperative shoulder pain | Count of Participants | Participants |
|
| Comorbidities | Count of Participants | Participants |
|
|
|
|
| Secondary | Time to First Opioid Medication | From block time to the first dose of opioids given, measured in hours. | Missing data for 2 patients from the Liposomal Bupivacaine 1.3% group. 3 patients withdrew consents from the Bupivacaine 0.5% with Adjuncts group. | Posted | Median | Inter-Quartile Range | hours | from the time of the block injection until discharge, assessed up to 72 postoperative hours. |
|
|
|
|
| Secondary | Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours | Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain. | Three patients withdrew consent from the control group (Bupivacaine 0.5% with adjuncts) and one from the liposomal bupivacaine group. The rest is missing data from lost to follow-up. | Posted | Median | Inter-Quartile Range | units on a scale 0-10 | 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60 |
|
|
|
|
| Secondary | Hospital Length-of-stay | From the date and time of admission to the date and time of discharge, Measured in hours. | Posted | Median | Inter-Quartile Range | hour | From the date of admission until discharge, assessed up to 72 hours. |
|
|
|
|
| Secondary | Assessment of Patient Overall Satisfaction With Pain Control | Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate. | One patient withdrew consent from the Liposomal group just prior to 60 postoperative days, and three patients withdrew consent from the control group at the end of days 2, 3, and 4. The other missing data is from patients who lost to follow up from both groups. | Posted | Count of Participants | Participants | POD4 - 60 days |
|
|
|
|
| Secondary | Incidence of Distress From Block Numbness | On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day. | Although one patient from the control group decided to withdraw consent at the end of the second day following surgery, their data was included for this outcome as the withdrawal happened after collection. However, there was some missing data. | Posted | Count of Participants | Participants | At PACU and Postoperative day 2 |
|
|
|
|
| Secondary | Duration of Sensory Nerve Block | Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60. | Posted | Count of Participants | Participants | Day 1, after Day 1 (day 2 to 60), and at postoperative day 60 |
|
|
|
|
| Secondary | Day of the Final Opioids Used | The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours. | Three patients were missing from (Bupivacaine 0.5% with Adjuncts) group because of withdrawal. | Posted | Median | Inter-Quartile Range | day | 0-96 postoperative hours |
|
|
|
|
| Secondary | Motor Recovery | The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5): 0= No detectable muscle contraction (visible or palpation)
The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data. | Posted | Count of Participants | Participants | PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60. |
|
|
|
|
| Other Pre-specified | Total Amount of Opioid Consumed During the Indicated Time Periods | Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours. | One patient withdrew consent on the second postoperative day from the control group, then two patients withdrew on the third and fourth postoperative days from the control group. | Posted | Median | Inter-Quartile Range | MME/day | 0-24, 24-48, 48-72, and 72-120 postoperative hours. |
|
|
|
|
| 0 |
| 45 |
| 0 |
| 45 |
| 18 |
| 45 |
| EG001 | Bupivacaine 0.5% With Adjuncts | 20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block | 0 | 45 | 0 | 45 | 21 | 45 |
|
| Swelling | Surgical and medical procedures | Systematic Assessment | Swelling of shoulder surgical site |
|
| Inflammation | Surgical and medical procedures | Systematic Assessment |
|
| Bruising | Surgical and medical procedures | Systematic Assessment |
|
| Ringing in ears | Ear and labyrinth disorders | Systematic Assessment | On the block side |
|
| Numbness and tingling | Nervous system disorders | Systematic Assessment | Of same surgery side shoulder and arm |
|
| Nausea and vomiting | General disorders | Systematic Assessment |
|
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D002395 | Catecholamines |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| PACU-24 hours Minimum |
|
|
| PACU-24 hours Maximum |
|
|
| PACU-24 hours Average |
|
|
| 24-48 hours Minimum |
|
|
| 24-48 hours Maximum |
|
|
| 24-48 hours Average |
|
|
| 48-72 hours Minimum |
|
|
| 48-72 hours Maximum |
|
|
| 48-72 hours Average |
|
|
| 72-96 hours Minimum |
|
|
| 72-96 hours Maximum |
|
|
| 72-96 hours Average |
|
|
| 60 days postoperative Maximum |
|
|
| 60 days postoperative Average |
|
|
| 60 days postoperative Minimum |
|
|
For (PACU-24) minimum pain scores |
| Superiority |
| Wilcoxon (Mann-Whitney) | .747 | For (PACU-24 hr.) maximum pain score | Superiority |
| Wilcoxon (Mann-Whitney) | .604 | For (PACU-24 hr) average pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .002 | (24-48 hr) minimum pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | <0.01 | For (24-48 hr) maximum pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | <0.01 | For (24-48 hr) average pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .011 | (48-72 hr) minimum pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .001 | (48-72 hr) maximum pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .003 | (48-72 hr) average pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .230 | For (72-96 hr) minimum pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .007 | For (72-96 hr) maximum pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .011 | For (72-96 hr) average pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .378 | For (postoperative day 60) minimum pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .001 | For (postoperative day 60) maximum pain scores | Superiority |
| Wilcoxon (Mann-Whitney) | .403 | For (postoperative day 60) average pain scores | Superiority |
| below 10 |
|
| Missing data |
|
| POD60 |
|
|
Chi-squared for POD60
| 1.0 |
For POD60 |
| Superiority |
| Missing data |
|
| POD2 Distress |
|
Postoperative day 2
| Superiority |
| Not by day 60 |
|
| Missing data |
|
| First sensation |
|
First sensation |
| Superiority |
| Any movement after day1 |
|
| Any movement missing data |
|
| Return of full movement day 2-60 |
|
| Not yet by day 60 |
|
| Return of full movement missing data |
|
Full movement |
| Superiority |
| 24-48 hours |
|
|
| 48-72 hours |
|
|
| 72-120 hours |
|
|
MME24-48 |
| Superiority |
| Wilcoxon (Mann-Whitney) | .122 | MME48-72 | Superiority |
| Wilcoxon (Mann-Whitney) | .367 | MME 72-120 | Superiority |