Can Physical Activities Reduce Postoperative Pain in Adults
NCT ID: NCT04293250
Last Updated: 2021-06-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1600 participants
INTERVENTIONAL
2015-07-01
2017-12-31
Brief Summary
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Detailed Description
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ERAS is a prevalent policy that combines evidence-based perioperative care to accelerate surgical recovery, Anesthesiologists are involved in many perioperative ERAS elements of patients in terms of evaluation and implementation: e.g., like prehabilitation via education of physical and core muscles training on the pain management clinic, perioperative multi-modal pain management and multi-modal anti-emetic prophylaxis against PONV.
The overarching aim of multimodal structured prehabilitation programs is to increase, for instance, the cardiopulmonary and musculoskeletal preoperative functional reserve, leading to better postoperative functional recovery and a reduced incidence of complications.
Better ischemic pain tolerance is well documented after combined moderate-and vigorous-intensity aerobic exercise for healthy individuals and acute exercise also has hypoalgesic effects.Unfortunately, these physical activity (PA) researchers have not evaluated specifically effects on postoperative pain and PONV.
The goal of our study is to determine the relationship between preoperative PA on postoperative pain and PONV for different types of surgery.
METHODS:
This is a single center, randomized prospective (preoperative PA patients group vs preoperative non-PA patients group) trial. Information on the incidence and severity of pain and PONV of each patient are periodically recorded at time-points of 1, 4, 7, 10 and 24 hours after various types of surgical operation. Our study was aimed to determine beneficial effects on postoperative pain and PONV for patients after performing preoperative PA for 6 to 8 weeks vs non-PA patients. The investigators employed the recommendations of the American College of Sport Medicine and the World Health Organization for adults to divide our PA patients group into moderate-intensity as 30-60 min∙d-1 (≥150 min∙wk-1 ) and vigorous-intensity as 20-60 min∙d-1 (≥75 min∙wk-1). The severity of postoperative pain and PONV were measured at 1, 4, 7, 10 and 24 hours after the surgical operations for the PA patients group and the non-PA patients group by one of the three registered nurses of our Anesthesiology Department. The severity of postoperative pain were recorded by using 0-10 Numeric Rating Scale and postoperative nausea and vomiting after surgeries were measured by using 5 points Likert Scale (1-5) to record the severity of postoperative pain and PONV after different types of surgery.
The operations were performed under general anesthesia (GA) with endotracheal intubation or inhalation through laryngeal mask.
The procedures of GA will be discussed and decided by one of our anesthesiologists of the Chia-Yi Christian Hospital together with patients/caregivers at the Pre-Anesthesia Consultation Clinic. We used the American Society of Anesthesiologists physical status scoring system for risk stratification, the approaches of Apfel's preventive strategy of postoperative nausea and vomiting prophylaxis, perioperative multi-modal pain management in addition to other appropriate elements in ERAS. PONV defined as nausea, vomiting or retching within 24 h of surgery.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Physical activity group
1. Investigators employ the recommendations of the American College of Sport Medicine and the World Health Organization for adults to divide our enrolled patients having moderate-intensity as 30-60 min∙d-1 (≥150 min∙wk-1 ) or vigorous-intensity as 20-60 min∙d-1 (≥75 min∙wk-1) for 6-8 weeks preoperatively.
2. The severity of postoperative pain are measured prospectively at 1, 4, 7, 10 and 24 hours after the surgical operations.
3. The operations are performed under inhalation general anesthesia with endotracheal intubation or through laryngeal mask.
Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group
Compare postoperative pain scores for the physical activity Vs non-physical activity group
non-physical activity group
1. No any moderate-intensity or vigorous-intensity physical activity for our enrolled patients preoperatively.
2. The severity of postoperative pain are measured prospectively at 1, 4, 7, 10 and 24 hours after the surgical operations.
3. Various types of operations are performed under inhalation general anesthesia with endotracheal intubation or through laryngeal mask.
Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group
Compare postoperative pain scores for the physical activity Vs non-physical activity group
Interventions
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Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group
Compare postoperative pain scores for the physical activity Vs non-physical activity group
Eligibility Criteria
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Inclusion Criteria
2. Enrolled in-patients
3. Patients are scheduled to undergo various operations.
4. The surgeries are expected to last ≥60 minutes
5. Endotracheal intubation or laryngeal mask inhalation general anesthesia.
Exclusion Criteria
2. American Society of Anesthesiology physical status ≥4
3. poorly controlled diabetic mellitus (HA1c ≥9)
4. prolonged corrected QT interval (male ≥0.45 sec, female ≥0.47 sec)
5. Allergy to any opioids (i.e., morphine, fentanyl, pethidine and others) and nonopioids (i.e., selective or nonselective NSAIDs and acetaminophen)
6. Allergy to dexamethasone, granisetron, droperidol, metoclopramide used for prevention of postoperative nausea and vomiting
7. Deaf or unable to speak/understand Taiwanese or Mandarin
8. Failed to recall or uncertain on how many days/times they had spent doing moderate or vigorous physical activity on recent 6 to 8 weeks before receiving surgery.
18 Years
ALL
No
Sponsors
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Chiayi Christian Hospital
OTHER
Responsible Party
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Principal Investigators
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Wui-Chiu Mui, M.D., MBA
Role: PRINCIPAL_INVESTIGATOR
Chiayi Christian Hospital
References
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Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014 Jan;30(1):149-60. doi: 10.1185/03007995.2013.860019. Epub 2013 Nov 15.
Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
Pogatzki-Zahn EM, Segelcke D, Schug SA. Postoperative pain-from mechanisms to treatment. Pain Rep. 2017 Mar 15;2(2):e588. doi: 10.1097/PR9.0000000000000588. eCollection 2017 Mar.
Milliken D, Schofield N. Understanding Prehabilitation. Anaesthesia 2018; Tutorial Of The Week 394: 1-5.
Jones MD, Booth J, Taylor JL, Barry BK. Aerobic training increases pain tolerance in healthy individuals. Med Sci Sports Exerc. 2014 Aug;46(8):1640-7. doi: 10.1249/MSS.0000000000000273.
Naugle KM, Riley JL 3rd. Self-reported physical activity predicts pain inhibitory and facilitatory function. Med Sci Sports Exerc. 2014 Mar;46(3):622-9. doi: 10.1249/MSS.0b013e3182a69cf1.
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
Hu L, Bentler PM. Cutoff criteria for fit indexes in covariance structure analysis: conventional criteria versus new alternatives. Structural Equation Modeling 1999; 6(1): 1-55
Other Identifiers
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104042
Identifier Type: -
Identifier Source: org_study_id
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