Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04739787 |
| Other study ID # |
ChiayiCH |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2021 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
August 2021 |
| Source |
Chiayi Christian Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
Description:
Despite the increasing knowledge on the mechanisms of incisional inflammation, transmission
of nociception signals, peripheral and central sensitization, and on top of the current
advancements in pharmacology, pharmaceutics, techniques and equipment, unfortunately, 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, that is, breast neoplasms,
thoracic, laparoscopic abdominal, abdominal laparotomy, Ears-Nose-Throat, urinary tract
stones and tumors, orthopedic, plastic, spinal and colorectal surgeries.
METHODS:
This is a single center, observational retrospective (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. 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.
The principle investigator is responsible for the data collection of this retrospective study
and recorded of the severity of the postoperative pain and PONV at time-points of 1, 4, 7, 10
and 24 hours after various types of surgical operation via the "Postanesthesia Patient
Interview and Record Sheet" and the nursing care recorded at the ward for the PA patients
group and the non-PA patients group.
