Clinical trial NCT06785350: Optimal Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery
Official title: Optimal Dose of Incisional Local Infiltration Betamethasone for the Prevention of Pain After Spinal Surgery: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain Management
Spine Surgery
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-01-21
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Incisional pain is a common complication after surgery and is an important cause of delayed postoperative recovery, increased length of hospital stay, increased risk of wound infection and respiratory/cardiovascular complications, as well as an important medical, social, and economic problem. Prevention and treatment of postoperative incision pain remains challenging. Local Infiltration Anaesthesia (LIA) for surgical incisions with an anti-inflammatory and analgesic combination has been reported to be effective in reducing postoperative pain, but there is a gap in the research on the optimal concentration of anti-inflammatory drugs in the anti-inflammatory and analgesic combination during local infiltration. The aim of this study was to investigate the optimal concentration of anti-inflammatory drugs in the anti-inflammatory-analgesic combination solution used for local infiltration of spinal surgical incisions to prevent postoperative pain.


Eligibility criteria: Inclusion Criteria:

Patients scheduled for spine surgery under general anesthesia. Anticipated cervical, thoracic, and lumbar spine surgeries (within three level).

Patients age 18-65 years. American Society of Anaesthesiologists Classification of I or II.

Exclusion Criteria:

Patients refuse to participate. Patients who are allergic to ropivacaine, betamethasone and opioid, . Pateints who have been abusing drugs or alcohol. Patients who have abnormalities in kidney or liver function tests. BMI\<15kg/m2 or\>35 kg/m2. Patient has a history of spinal surgery. Patient has peri-incisional infection. Patient has a history of stroke or other serious neurological disease. Patient has a history of diabetes and other metabolic disorders. Patient has a history of psychological disorders. Patient is on systemic steroids. Patient is pregnant or breastfeeding. Glasgow Coma Scale score \< 15 before surgery. Unable to provide written informed consent.

Withdrawal criteria:

Voluntary withdrawal. Delayed extubation. Poor cognitive function within 48 hours after surgery. Postoperative radiation therapy or chemotherapy during follow-up. Postoperative diagnosis of spinal cord or nerve root injury resulting in pain during follow-up.

Reoperation during follow-up.

Primary outcomes:
measure: postoperative sufentanil consumption via PCA
timeFrame: At 48 hours after the operation
Secondary outcomes:
measure: Cumulative consumption of sufentanil by PCA
timeFrame: During 0-4hours, 4-8hours, 8-24hours and 24-48hours after operation
measure: PCA pump first press time
timeFrame: Within 48 hours after the operation.
measure: VAS score at during movement (VASm) and at rest (VASr)
timeFrame: At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively
measure: Intraoperative opioid dosage
timeFrame: During the operation
measure: Time to first analgesic remediation
timeFrame: Until 3 months after surgery
measure: Amount of postoperative oral analgesic remediation
timeFrame: Until 3 months after surgery
measure: Postoperative nausea and vomiting (POVN)
timeFrame: At 2hours, 4hours, 8hours, 24hours, and 48hours postoperatively
measure: Ramsay sedation score (RSS)
timeFrame: At 2hours, 4hours, 8hours, 24hours, 48hours postoperatively
measure: Satisfaction score
timeFrame: At 2hours, 4hours, 8hours, 24hours, 48hours, 72hours, 1week, 2weeks, 6weeks, 3months postoperatively
measure: The World Health Organization Quality of Life (WHOQOL)
timeFrame: At 3months postoperatively
measure: Oswestry disability index (ODI)
timeFrame: At 3months postoperatively
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: At 3months postoperatively
measure: Adverse events
timeFrame: At 3months postoperatively
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
References: