Postoperative Pain, Acute, VATS
Conditions
Keywords
TaVNS, Postopearvie pain, VATS
Brief summary
Transcutaneous auricular vagus nerve stimulation (taVNS) is a novel pain management technique that has gained popularity in recent years due to its non-invasive nature and ease of operation. Current literature has substantiated its efficacy in managing pain syndromes and chronic pain. However, there is a paucity of evidence regarding its effectiveness in treating acute postoperative pain. This project aims to explore the efficacy of taVNS in postoperative pain management, with a focus on video-assisted thoracic surgery(VATS). The investigators have designed a double-blind, single-center, randomized controlled clinical trial, planning to enroll 116 patients scheduled to undergo VATS(including segmentectomy or lobectomy) under general anesthesia at Peking Union Medical College Hospital. Participants will be divided into an intervention group (receiving taVNS) and a sham intervention group (receiving sham-taVNS), and will undergo a 2-hour intervention on the first postoperative day. The primary outcome is the pain relief rate, defined as a reduction of 15mm or 30% in the VAS (1-100mm) score immediately before and after the intervention on the first postoperative day. Secondary outcomes include: the proportion of patients with inadequate analgesia within three days after intervention; the difference in VAS scores immediately before and after the intervention on the first postoperative day; the incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention; the number of effective and ineffective PCA presses (if used) from the first to the third postoperative day after intervention; the specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention; the difference in RCSQ scores on the night of surgery and the night after intervention; and the probability of patients experiencing surgery-related pain three months after surgery. Follow-up period for this study will be three months after surgery.
Interventions
Participants enrolled will have a commercial transcutaneous electrical nerve stimulation unit (tVNS501,RISHENA,Changzhou,China) attached to their left outer ear after VATS. The stimulation pulses will target at the cymba concha which is 100% dominated by the auricular branch of the vagus nerve. Stimulation pulses will be 25Hz in frequency according to current clinical research, 500µs in pulse width which has been suggested to be most biologically active, with its amplitude increasing to the maximum amount that the patients can tolerate without pain.
The only thing differs with the taVNS group is that the device will automatically shut down after running for 15 seconds.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years or older; 2. ASA classification I-III; 3. No prior taVNS treatment; 4. Scheduled to undergo VATS (including segmentectomy and lobectomy); 5. VAS ≥ 30 mm at any time on the day of surgery; 6. Patients and their families can understand the study design and are willing to cooperate and participate in the study.
Exclusion criteria
1. Psychiatric disorders or other conditions that prevent cooperation; 2. Long-term use of steroids or opioids; 3. Scheduled for bilateral VATS surgery; 4. History of thoracic surgery; 5. History of chronic pain, autoimmune diseases, or persistent infections. Withdrawl Criteria: 1. Patient request; 2. Surgery cancellation or change in surgical method resulting in failure to meet inclusion criteria; 3. Severe perioperative complications and adverse events; 4. Severe intervention-related adverse events.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief Rate | First postoperative day | Pain relief rate is defined as a reduction of 15mm or 30% in the VAS (Visual Analogue Scale, 1-100mm) score immediately before and after the intervention on the first postoperative day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference in VAS scores immediately before and after the intervention on the first postoperative day | First postoperative day | — |
| The incidence of opioid-related and taVNS-related side effects from the first to the third postoperative day after intervention | First to the third postoperative day | — |
| The number of effective and ineffective PCA attempts (if used) from the first to the third postoperative day after intervention | First to the third postoperative day | — |
| The proportion of patients with inadequate analgesia within three days after intervention | Within three days after the intervention | Inadequate analgesia is defined as: 1) VAS ≥ 40 mm at any time within three days after the intervention; or 2) the need for additional analgesic medication in the ward after the intervention, or the occurrence of ineffective PCA presses. Meeting either of the above criteria satisfies the definition. |
| The difference in RCSQ scores on the night of surgery and the night after intervention | First to second postoperative day | — |
| The probability of patients experiencing surgery-related pain three months after surgery | Three months after surgery | The investigators will conduct a telephone follow-up with participants three months later to assess whether they still experience surgery-related pain after discharge. The outcome will be recorded as yes or no based on the patient's subjective description. |
| The specifics and frequency of additional analgesic measures taken by patients from the first to the third postoperative day after intervention | First to the third postoperative day | The investigators will document any additional analgesic measures taken by the patients within three days after the intervention, including: The name, dosage, and administration method of analgesic medications; The formulation and settings of patient-controlled analgesia (PCA) pumps, along with the counts of effective and ineffective PCA attempts; Any physical analgesic measures employed. |
Countries
China
Contacts
Primary ContactXu Tao
Outcome results
None listed