Clinical trial NCT04293250: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Physical Activity
Keywords: postoperative pain
Physical Activity
Non-Physical Activity
Enhanced Recovery After Surgery
Prehabilitation
Lead sponsor: Chiayi Christian Hospital
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: latent growth modeling using structural equation model,
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The beneficial effect of physical activity on postoperative pain after various types of surgeries
timeFrame: 2 years and 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chiayi Christian Hospital
name: Wui-Chiu Mui, M.D., MBA
role: PRINCIPAL_INVESTIGATOR
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