Can Physical Activities Reduce Postoperative Pain in Adults

June 11, 2021 updated by: Chiayi Christian Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

1600

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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
Experimental: 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.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiayi Christian Hospital

Investigators

  • Principal Investigator: Wui-Chiu Mui, M.D., MBA, Chiayi Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

June 30, 2016

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

February 28, 2020

First Posted (Actual)

March 3, 2020

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 104042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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