Clinical trial NCT06801587: Preemptive Co-infiltration of Triamcinolone Acetonide with Ropivacaine for Postoperative Pain in Major Spinal Surgery
Official title: Preemptive Co-infiltration of Triamcinolone Acetonide with Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pain
Postoperative
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 118
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: Patients undergoing major spinal surgery usually experience moderate to-severe postoperative pain. Inadequate pain control may lead to severe complications.

Local infiltration analgesia (LIA) with a local anesthetic, is a simple, minimally invasive, and effective postoperative pain management technique. However, LIA with local anesthetic alone can only last for a short time, steroid as adjuvant can enhance postoperative analgesia and prolong postoperative analgesia time. Triamcinolone acetonide as an adjunctive infiltration to local anesthesia presented a superior analgesic benefit compared with local anesthesia alone in various types of surgeries. To date, no studies have evaluated the additive analgesia effects of triamcinolone acetonide on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of triamcinolone acetonide and ropivacaine in surgical incision will further reduce postoperative opioid requirements and pain score after spinal surgery than that of ropivacaine alone.


Eligibility criteria: Inclusion Criteria:

Age 18-65 years; Patients scheduled for elective laminoplasty or laminectomy with no more than 3 levels under general anesthesia; American Society of Anesthesiologists (ASA) physical status of I-III; Anticipated full recovery and cooperation within 2 hours postoperatively.

Exclusion Criteria:

History of spinal surgery; Inability to use a patient-controlled analgesia (PCA) pump or comprehend the pain visual analog scale (VAS); Body mass index (BMI)\<15kg/m2 or \>35kg/m2; Peri-incisional infection; History of diabetes mellitus and other metabolic diseases; History of severe cardiopulmonary, hepatic or renal dysfunction; Preoperative coagulation abnormalities (activated partial thromboplastin time greater than 1.5 times normal value); History of allergies to any of the study drugs; History of alcohol or drugs abuse (more than 2 weeks), or use of any analgesic within 24h before surgery; Use of systemic steroids within 1 week before surgery; History of psychiatric disorders, chronic neck or back pain; History of radiation therapy and chemotherapy or with a high probability of such treatment postoperatively; Pregnant or breastfeeding; Refusal to sign informed consent.

Primary outcomes:
measure: The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.
timeFrame: Within 24 hours after spinal surgery
Secondary outcomes:
measure: The cumulative consumption of sufentanil via PCA pump between 24 hours and 48 hours postoperatively.
timeFrame: Between 24 hours and 48 hours after spinal surgery
measure: Number of patients without PCA press button
timeFrame: Within 48 hours after spinal surgery
measure: The time of first PCA demand
timeFrame: Within 48 hours after spinal surgery
measure: The total number of PCA presses including both valid and invalid presses
timeFrame: Within 48 hours after spinal surgery
measure: Postoperative visual analogue scale (VAS) score during movement(VASm)
timeFrame: At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
measure: Postoperative VAS score at rest(VASr)
timeFrame: At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
measure: Total consumption of Tylenol as supplementary analgesia
timeFrame: Four separate postoperative periods ( 0- postoperative 48 hours, postoperative 48 hours-postoperative 2 weeks, postoperative 2 weeks-postoperative 1 month, and postoperative 1 month-postoperative 3 months)
measure: Patient Satisfaction Score (PSS) with pain relief
timeFrame: At 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks 1 month and 3 months postoperatively
measure: Postoperative nausea and vomiting (PONV) score
timeFrame: At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
measure: Ramsay Sedation Scale (RSS)
timeFrame: At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
measure: Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)
timeFrame: At 2 weeks, 1 month and 3 months postoperatively
measure: Rate of steroid-related side effects and complications
timeFrame: Through the whole follow-up, an average of 3 months
measure: Readmission rate within 3 months after spine surgery
timeFrame: Through the whole follow-up, within 3 months after spine surgery
measure: Length of Postoperative Anesthesia Care Unit (PACU) stay
timeFrame: Approximately 30 minutes to 2 hours after surgery
measure: Duration of hospitalization after surgery
timeFrame: Approximately 1-2 weeks after surgery
measure: Total consumption of remifentanil during surgery
timeFrame: During surgery
measure: Total consumption of loxoprofen
timeFrame: From postoperative 48 hours to approximately 1-2 weeks after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
Study officials:
affiliation: Beijing Tiantan Hospital
name: Fang Luo
role: PRINCIPAL_INVESTIGATOR
References: