Pain PostoperativeNCT05885802
Sngception and Pain in Spine Enhanced Recovery After Surgery (ERAS) Pathways
An observational study of Pain Postoperative, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pain Postoperative
- What is being tested?
- No specific intervention other than routine anesthesia protocol
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Mar 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving routine ERAS management for spine surgeries. All patients will be screened for eligibility.
Who may be able to join
- Patients undergoing routine ERAS protocol for spine surgeries
- American Society of Anesthesiologists Physical Status (ASA-PS) I~III
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei City, Taipei, 11217
Hsu Professor Ma, Ph.D., +886 02 28712121, irbopinion@vghtpe.gov.tw
About this study
Official title: 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.
Read more
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.
- Conditions
- Pain Postoperative
- Being tested
- No specific intervention other than routine anesthesia protocol
- Keywords
- enhanced recovery, ERAS, Spine surgery, pain, sngception, sng
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No specific intervention other than routine anesthesia protocolOther
No specific intervention other than routine anesthesia protocol
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Routine spine surgical patients receiving ERAS protocol that complies with current guidelines. Receives: Other: No specific intervention other than routine anesthesia protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Sngception (Sng)
Sng score evaluated by the numerical rating scale (NRS, score 0~10).
Measured: From enrollment to 1 year after surgery.
Postoperative Pain
Pain score evaluated by the numerical rating scale (NRS, score 0~10).
Measured: From enrollment to 1 year after surgery.
Secondary outcomes (1)
Morphine consumption
Postoperative morphine consumption converted to Morphine Sulfate Equivalents (MSE)
Measured: From enrollment to discharge, an average of 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start29 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain PostoperativeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- National Taiwan University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885802
- Sponsor's protocol ID
- IRB 2022-09-009BC
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30486810
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Sngception and Pain in Enhanced Recovery After Surgery (ERAS) for Spine Surgeries
- ClinicalTrials.gov ID
- NCT05885802
- Acronym / sponsor ID
- IRB 2022-09-009BC
- Conditions
- Pain Postoperative
- Keywords
- enhanced recovery, ERAS, Spine surgery, pain, sngception, sng
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- National Taiwan University Hospital
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERAS group | – | Other: No specific intervention other than routine anesthesia protocolRoutine spine surgical patients receiving ERAS protocol that complies with current guidelines. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving routine ERAS management for spine surgeries. All patients will be screened for eligibility.
Key inclusion criteria (2 listed)
- Patients undergoing routine ERAS protocol for spine surgeries
- American Society of Anesthesiologists Physical Status (ASA-PS) I~III
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No specific intervention other than routine anesthesia protocolNo specific intervention other than routine anesthesia protocol | Other | ERAS group |
Primary outcome
Postoperative Sngception (Sng)
Time frame: From enrollment to 1 year after surgery.
Sng score evaluated by the numerical rating scale (NRS, score 0~10).
Postoperative Pain
Time frame: From enrollment to 1 year after surgery.
Pain score evaluated by the numerical rating scale (NRS, score 0~10).
1 secondary outcome
Morphine consumption
Time frame: From enrollment to discharge, an average of 5 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Background: PubMed 30486810Lin 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain Postoperative, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Yang Dr. Liou, MD (886+ 02-28767549 ext. 368, archmastertw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Sngception (Sng) (time frame: From enrollment to 1 year after surgery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.