Sngception and Pain in Spine Enhanced Recovery After Surgery (ERAS) Pathways

Pain Postoperative Clinical Trial

Official title:

The Role of Sngception and Pain in Enhanced Recovery After Surgery (ERAS) for Spine Surgeries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05885802
• Other study ID #: IRB 2022-09-009BC
• Status: Recruiting
• Start date: March 29, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Jing Yang Dr. Liou, MD
• Phone: 886+ 02-28767549
• Email: archmastertw[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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. a sensation different from nociception,

2. usual painkillers are ineffective, suggesting an alternative route of transmission,

3. relieved by movement,

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing routine ERAS protocol for spine surgeries

2. American Society of Anesthesiologists Physical Status (ASA-PS) I~III

Exclusion Criteria:

1. Communication issues that preclude proper preoperative counselling for ERAS and study design.

2. Active alcohol or drug addiction.

3. Pregnancy

4. Allergy to main anesthetics that preclude the use of routine ERAS anesthesia management.

5. Patient refusal to participate in study.

6. Emergent operations.

Related Conditions & MeSH terms

• Pain Postoperative
• Pain, Postoperative

Intervention

Other:
• No specific intervention other than routine anesthesia protocol
No specific intervention other than routine anesthesia protocol

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei City	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan	National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Sngception (Sng)	Sng score evaluated by the numerical rating scale (NRS, score 0~10).	From enrollment to 1 year after surgery.
Primary	Postoperative Pain	Pain score evaluated by the numerical rating scale (NRS, score 0~10).	From enrollment to 1 year after surgery.
Secondary	Morphine consumption	Postoperative morphine consumption converted to Morphine Sulfate Equivalents (MSE)	From enrollment to discharge, an average of 5 days.