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Can Physical Activities Reduce Postoperative Pain in Adults

Primary Purpose

Postoperative Pain, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group
Sponsored by
Chiayi Christian Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain focused on measuring postoperative pain, Physical Activity, Non-Physical Activity, Enhanced Recovery After Surgery, Prehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. aged ≥18 y/o
  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:

  1. Patients will transferred to the intensive care unit after operations.
  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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Physical activity group

    non-physical activity group

    Arm Description

    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. The severity of postoperative pain are measured prospectively at 1, 4, 7, 10 and 24 hours after the surgical operations. The operations are performed under inhalation general anesthesia with endotracheal intubation or through laryngeal mask.

    No any moderate-intensity or vigorous-intensity physical activity for our enrolled patients preoperatively. The severity of postoperative pain are measured prospectively at 1, 4, 7, 10 and 24 hours after the surgical operations. Various types of operations are performed under inhalation general anesthesia with endotracheal intubation or through laryngeal mask.

    Outcomes

    Primary Outcome Measures

    The beneficial effect of physical activity on postoperative pain after various types of surgeries
    The pain scores different of the physical activity (PA) Vs non-physical activity (non-PA) groups are using the numeric pain rating scale (NRS) with 1 represent no pain and 5 represent the worst possible pain. The severity of postoperative pain will be measured prospectively by using NRS at different postoperative time points (i.e. 1, 4, 7, 10, and 24 hour) for comparing the postoperative pain different between PA and non-PA patients.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 30, 2020
    Last Updated
    June 11, 2021
    Sponsor
    Chiayi Christian Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04293250
    Brief Title
    Can Physical Activities Reduce Postoperative Pain in Adults
    Official Title
    Preoperative Moderate-to-vigorous Intensity Physical Activities Reduce Postoperative Pain in Adults
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 1, 2015 (Actual)
    Primary Completion Date
    June 30, 2016 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chiayi Christian Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Recommendation is strong on physical activity (PA) in the prehabilitation of Enhanced Recovery After Surgery (ERAS) for various types of surgeries. The evidence is however weak regarding ERAS protocols. Many studies have showed that physical exercise and PA have hypoalgesic effects on healthy individuals and they have better pain tolerance too. Here the investigators study changes in postoperative pain and postoperative nausea and vomiting for various types of surgical patients after performing preoperative PA at moderate or vigorous intensity Vs non-preoperative PA patients.
    Detailed Description
    The US Institute of Medicine revealed that 80% of patients receiving surgery have reported postoperative pain with 88% of them at moderate, severe, or extreme levels. Opioids for postoperative pain are commonly administered to relieve moderate to severe pain, therefore, the postoperative nausea and vomiting (PONV) incidence will be increased. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Pain, Physical Activity
    Keywords
    postoperative pain, Physical Activity, Non-Physical Activity, Enhanced Recovery After Surgery, Prehabilitation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Model Description
    latent growth modeling using structural equation model,
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    1600 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical activity group
    Arm Type
    Experimental
    Arm Description
    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. The severity of postoperative pain are measured prospectively at 1, 4, 7, 10 and 24 hours after the surgical operations. The operations are performed under inhalation general anesthesia with endotracheal intubation or through laryngeal mask.
    Arm Title
    non-physical activity group
    Arm Type
    Experimental
    Arm Description
    No any moderate-intensity or vigorous-intensity physical activity for our enrolled patients preoperatively. The severity of postoperative pain are measured prospectively at 1, 4, 7, 10 and 24 hours after the surgical operations. Various types of operations are performed under inhalation general anesthesia with endotracheal intubation or through laryngeal mask.
    Intervention Type
    Procedure
    Intervention Name(s)
    Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group
    Intervention Description
    Compare postoperative pain scores for the physical activity Vs non-physical activity group
    Primary Outcome Measure Information:
    Title
    The beneficial effect of physical activity on postoperative pain after various types of surgeries
    Description
    The pain scores different of the physical activity (PA) Vs non-physical activity (non-PA) groups are using the numeric pain rating scale (NRS) with 1 represent no pain and 5 represent the worst possible pain. The severity of postoperative pain will be measured prospectively by using NRS at different postoperative time points (i.e. 1, 4, 7, 10, and 24 hour) for comparing the postoperative pain different between PA and non-PA patients.
    Time Frame
    2 years and 6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: aged ≥18 y/o Enrolled in-patients Patients are scheduled to undergo various operations. The surgeries are expected to last ≥60 minutes Endotracheal intubation or laryngeal mask inhalation general anesthesia. Exclusion Criteria: Patients will transferred to the intensive care unit after operations. American Society of Anesthesiology physical status ≥4 poorly controlled diabetic mellitus (HA1c ≥9) prolonged corrected QT interval (male ≥0.45 sec, female ≥0.47 sec) Allergy to any opioids (i.e., morphine, fentanyl, pethidine and others) and nonopioids (i.e., selective or nonselective NSAIDs and acetaminophen) Allergy to dexamethasone, granisetron, droperidol, metoclopramide used for prevention of postoperative nausea and vomiting Deaf or unable to speak/understand Taiwanese or Mandarin 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Wui-Chiu Mui, M.D., MBA
    Organizational Affiliation
    Chiayi Christian Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29392204
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    24237004
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28097305
    Citation
    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.
    Results Reference
    background
    Citation
    Milliken D, Schofield N. Understanding Prehabilitation. Anaesthesia 2018; Tutorial Of The Week 394: 1-5.
    Results Reference
    background
    PubMed Identifier
    24504426
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    23899890
    Citation
    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.
    Results Reference
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    PubMed Identifier
    16367493
    Citation
    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.
    Results Reference
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    PubMed Identifier
    6668417
    Citation
    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.
    Results Reference
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    Citation
    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
    Results Reference
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