- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05885802
Sngception and Pain in Spine Enhanced Recovery After Surgery (ERAS) Pathways
The Role of Sngception and Pain in Enhanced Recovery After Surgery (ERAS) for Spine Surgeries
Enhanced recovery after surgery (ERAS) is a recognized, evidence-based and patient-centered clinical pathway that has an array of benefits. Minimally invasive techniques, a cyclopedic pain management plan and precise administration of anesthetics, which will render patients a rapid and comfortable recovery if executed correctly, followed by early mobilization and discharge.
Pain management practice is traveling through a paradigm shift as opioid crises arise in the western countries. Opioid-based pain control is being disarmed and replaced by multimodal analgesia (MMA) and becoming the mainstay strategy. Opioids are increasingly being reserved as rescue medications. MMA target different parts of the nociceptive pathway, preventing its wind-up during surgery. Decreased firing of the nociceptive neurons may be linked to lower postoperative pain scores or even the suppressing chronic pain incidence. In our ERAS pathway, we implement erector spinae plane block (ESPB) as the main analgesic firepower.
As postoperative pain decreases, an observed rising complaint is "sng", or soreness, in native Taiwanese in our ERAS spine patients. It is very different from the nociceptive "pain" we are familiar with. Patients avoid movements if it causes pain, but they tend to stretch or adjust postures if sngception dominates. The term "sngception" has been proposed in 2018 by Taiwanese scholars. It is believed to be a sense of acidosis, possibly within the muscles. Acidosis and associated pain are well documented, such as in muscle aches from exercise, cancer or diabetic ketoacidosis. The underlying mechanism is yet to be established but does not entirely overlap with nociception. There are numerous similarities of sngception in our patients and sngception:
- a sensation different from nociception,
- usual painkillers are ineffective, suggesting an alternative route of transmission,
- relieved by movement,
- inflammation and acidosis in the vicinity of surgical wound. In this study, we intended to characterize sngception by observing various perioperative factors, as well as the short- and long- term outcomes they bring. This will be done through a detailed sngception and pain trajectory analysis. Only when we know the main causative factor(s), we can design treatment plans toward guarding against sngception. This further improves the quality of postoperative recovery and safety as less opioids may be required as rescue medications.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Jing Yang Dr. Liou, MD
- Phone Number: 368 886+ 02-28767549
- Email: archmastertw@gmail.com
Study Locations
-
-
Taipei
-
Taipei City, Taipei, Taiwan, 11217
- Recruiting
- Taipei Veterans General Hospital
-
Contact:
- Hsu Professor Ma, Ph.D.
- Phone Number: +886 02 28712121
- Email: irbopinion@vghtpe.gov.tw
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients undergoing routine ERAS protocol for spine surgeries
- American Society of Anesthesiologists Physical Status (ASA-PS) I~III
Exclusion Criteria:
- Communication issues that preclude proper preoperative counselling for ERAS and study design.
- Active alcohol or drug addiction.
- Pregnancy
- Allergy to main anesthetics that preclude the use of routine ERAS anesthesia management.
- Patient refusal to participate in study.
- Emergent operations.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
ERAS group
Routine spine surgical patients receiving ERAS protocol that complies with current guidelines.
|
No specific intervention other than routine anesthesia protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Sngception (Sng)
Time Frame: From enrollment to 1 year after surgery.
|
Sng score evaluated by the numerical rating scale (NRS, score 0~10).
|
From enrollment to 1 year after surgery.
|
|
Postoperative Pain
Time Frame: From enrollment to 1 year after surgery.
|
Pain score evaluated by the numerical rating scale (NRS, score 0~10).
|
From enrollment to 1 year after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morphine consumption
Time Frame: From enrollment to discharge, an average of 5 days.
|
Postoperative morphine consumption converted to Morphine Sulfate Equivalents (MSE)
|
From enrollment to discharge, an average of 5 days.
|
Collaborators and Investigators
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB 2022-09-009BC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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