Postoperative PainNCT04293250
Can Physical Activities Reduce Postoperative Pain in Adults
A study testing Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group in people with Postoperative Pain and Physical Activity, run by Chiayi Christian Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Physical Activity
- What is being tested?
- Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2015to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Preoperative Moderate-to-vigorous Intensity Physical Activities Reduce Postoperative Pain in Adults
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.
Read the 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.
- Conditions
- Postoperative Pain, Physical Activity
- Being tested
- Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group
- Keywords
- postoperative pain, Physical Activity, Non-Physical Activity, Enhanced Recovery After Surgery, Prehabilitation
- Medical subject headings
- Pain, Postoperative, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compare the severity of postoperative pain of the physical activity group Vs non-physical activity groupProcedure or surgery
Compare postoperative pain scores for the physical activity Vs non-physical activity group
| Study group | Role | What they receive |
|---|---|---|
| Physical activity group | Experimental | 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. Receives: Procedure: Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group |
| non-physical activity group | Experimental | 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. Receives: Procedure: Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jul 2015
- Primary completion30 Jun 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- latent growth modeling using structural equation model,
- Masking
- None (open label)
- Enrolment
- 1,600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiayi Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wui-Chiu Mui, M.D., MBA, Principal investigator, Chiayi Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293250
- Sponsor's protocol ID
- 104042
- Status last verified
- Feb 2020
- First submitted
- 30 Jan 2020
- Last updated
- 16 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29392204Gan 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.
PubMed 24237004Ljungqvist 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.
PubMed 28097305Milliken 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.
PubMed 24504426Naugle 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.
PubMed 23899890Diener 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.
PubMed 16367493Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Hu 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Moderate-to-vigorous Intensity Physical Activities Reduce Postoperative Pain in Adults
- ClinicalTrials.gov ID
- NCT04293250
- Acronym / sponsor ID
- 104042
- Conditions
- Postoperative Pain, Physical Activity
- Keywords
- postoperative pain, Physical Activity, Non-Physical Activity, Enhanced Recovery After Surgery, Prehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,600 participants (actual)
- Lead sponsor
- Chiayi Christian HospitalUniversity, hospital or other
- Study start
- 1 Jul 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- latent growth modeling using structural equation model,
| Arm | Type | Receives |
|---|---|---|
| Physical activity group | Experimental | Procedure: Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group1. 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. |
| non-physical activity group | Experimental | Procedure: Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group1. 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compare the severity of postoperative pain of the physical activity group Vs non-physical activity groupCompare postoperative pain scores for the physical activity Vs non-physical activity group | Procedure or surgery | Physical activity group, non-physical activity group |
Primary outcome
The beneficial effect of physical activity on postoperative pain after various types of surgeries
Time frame: 2 years and 6 months
1. 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. 2. 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Background: PubMed 29392204Pogatzki-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.
- Background: PubMed 24237004Gan 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.
- Background: PubMed 28097305Ljungqvist 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.
- BackgroundMilliken D, Schofield N. Understanding Prehabilitation. Anaesthesia 2018; Tutorial Of The Week 394: 1-5.
- Background: PubMed 24504426Jones 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.
- Background: PubMed 23899890Naugle 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.
- Background: PubMed 16367493Diener 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.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- BackgroundHu 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wui-Chiu Mui, M.D., MBA principal investigator
Chiayi Christian Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group in people with Postoperative Pain and Physical Activity, run by Chiayi Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The beneficial effect of physical activity on postoperative pain after various types of surgeries (time frame: 2 years and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04293250, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.