NCT05885802

Brief Summary

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:

  1. 1.a sensation different from nociception,
  2. 2.usual painkillers are ineffective, suggesting an alternative route of transmission,
  3. 3.relieved by movement,
  4. 4.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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 2, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2023

Enrollment Period

9 months

First QC Date

May 16, 2023

Last Update Submit

May 31, 2023

Conditions

Keywords

enhanced recoveryERASSpine surgerypainsngceptionsng

Outcome Measures

Primary Outcomes (2)

  • Postoperative Sngception (Sng)

    Sng score evaluated by the numerical rating scale (NRS, score 0\~10).

    From enrollment to 1 year after surgery.

  • Postoperative Pain

    Pain score evaluated by the numerical rating scale (NRS, score 0\~10).

    From enrollment to 1 year after surgery.

Secondary Outcomes (1)

  • Morphine consumption

    From enrollment to discharge, an average of 5 days.

Study Arms (1)

ERAS group

Routine spine surgical patients receiving ERAS protocol that complies with current guidelines.

Other: No specific intervention other than routine anesthesia protocol

Interventions

No specific intervention other than routine anesthesia protocol

ERAS group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving routine ERAS management for spine surgeries. All patients will be screened for eligibility.

You may qualify if:

  • Patients undergoing routine ERAS protocol for spine surgeries
  • American Society of Anesthesiologists Physical Status (ASA-PS) I\~III

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei City, Taipei, 11217, Taiwan

RECRUITING

Related Publications (1)

  • Lin JH, Hung CH, Han DS, Chen ST, Lee CH, Sun WZ, Chen CC. Sensing acidosis: nociception or sngception? J Biomed Sci. 2018 Nov 29;25(1):85. doi: 10.1186/s12929-018-0486-5.

    PMID: 30486810BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Jing Yang Dr. Liou, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 2, 2023

Study Start

March 29, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2024

Last Updated

June 2, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations