Preemptive Co-infiltration of Triamcinolone Acetonide With Ropivacaine for Postoperative Pain in Major Spinal Surgery

Preemptive Co-infiltration of Triamcinolone Acetonide With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery

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.

Study Overview

• Status: Completed
• Conditions: Pain; Postoperative
• Intervention / Treatment: Drug: Triamcinolone acetonide plus ropivacaine; Drug: Ropivacaine alone

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100070
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: The ropivacaine alone group; The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.	Drug: Ropivacaine alone; The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone. For local infiltration, a total of 30mL solution will be prepared for each group, which will include 15ml of ropivacaine added to 15mL of saline for ropivacaine group . The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.
Experimental: Triamcinolone acetonide plus ropivacaine group; The local infiltration solution in the triamcinolone acetonide plus ropivacaine group will consist of triamcinolone acetonide and ropivacaine.	Drug: Triamcinolone acetonide plus ropivacaine; The local infiltration solution in the triamcinolone acetonide plus ropivacaine group will consist of ropivacaine and triamcinolone acetonide. For local infiltration, a total of 30mL solution will be prepared for each group, 1 ml of triamcinolone acetonide (40mg per 1ml) plus 15 ml of 1% ropivacaine diluted to 30 ml with saline as the test drug in the triamcinolone acetonide group. The surgeon will perform incision infiltration before the skin incision. A total of 10 mL of solution will be injected into each level. The study solution will be injected into the entire thickness of the planned incision site. The epidural space and intrathecal space will not be infiltrated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cumulative consumption of sufentanil within 24 hours after spinal surgery via the PCA pump.	All participates will receive an electronic intravenous patient-controlled analgesia (PCA) pump. Participates will be advised to push the analgesic demand button if they feel pain	Within 24 hours after spinal surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients without PCA press button	Patients will use PCA device for postoperative analgesia. When the patients feel pain, the PCA button will be pressed. When the patients feel no pain, the PCA button will not be pressed. The PCA pump will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.	Within 48 hours after spinal surgery
The time of first PCA demand	The first time that the participants press PCA button.	Within 48 hours after spinal surgery
The total number of PCA presses including both valid and invalid presses	The total number that participants press PCA button including valid and invalid presses	Within 48 hours after spinal surgery
Patient Scar Assessment and the Observer Scar Assessment Scale (POSAS)	The POSAS consists of an Observer and a Patient Scale and includes a comprehensive list of items, based on clinically relevant scar characteristics. The observer scores six items: vascularization, pigmentation, thickness, surface roughness, pliability, and surface area. The patient scores six items: pain, pruritus, color, thickness, relief, and pliability. All included items are scored on the same polytomous 10-point scale, in which a score of 1 is given when the scar characteristic is comparable to normal skin and a score of 10 reflects the worst imaginable scar. All items are summed to give a total scar score, and therefore, a higher score represents a poorer scar quality.	At 2 weeks, 1 month and 3 months postoperatively
Duration of hospitalization after surgery	Duration of hospitalization after surgery (time required from the end of surgery to discharge from the hospital).	Approximately 1-2 weeks after surgery
Postoperative visual analogue scale (VAS) score during movement(VASm)	The pain will be assessed by VAS scores during movement (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)	At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
Postoperative VAS score at rest(VASr)	The pain will be assessed by VAS scores at rest (0 indicates no pain, 10 indicates the most severe pain imaginable, a higher score means worse pain)	At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively
Patient Satisfaction Score (PSS) with pain relief	4 scales; never, sometimes, usually or always	At 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks 1 month and 3 months postoperatively
Ramsay Sedation Scale (RSS)	The Ramsay Sedation Scale (RSS): A 6-point scale will be used to assess sedation levels, with 1 indicating agitated, anxious; 2, cooperative; 3, only responds to commands; 4, strong response to glabellar tapping or noisy stimulants; 5, weak response to glabellar tapping or noisy stimulants; 6, no response.	At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
Total consumption of loxoprofen	Pain management will be provided via the sufentanil PCA device for the first 48 hours following surgery. After that, patients will switch to taking oral loxoprofen 60 mg at a minimum interval of 8 hours and a maximum 180mg per day as needed until discharge.	From postoperative 48 hours to approximately 1-2 weeks after surgery
The cumulative consumption of sufentanil via PCA pump between 24 hours and 48 hours postoperatively.	Patients will use PCA device for pain management within the the first 48 hours after surgery. When the patients feel pain, the PCA button will be pressed. When the patients feel no pain, the PCA button will not be pressed. The PCA pump will provide a bolus of 2μg sufentanil with a 10 minutes lock-out time, and the maximum dose of sufentanil will be limited to 8μg/h.	Between 24 hours and 48 hours after spinal surgery
Total consumption of Tylenol as supplementary analgesia	During the initial postoperative 48 hours, when VAS>4 (either VASm or VASr) after pressing button four times with PCA pump for pain relief, patients will be treated for supplementary analgesia with oral Tylenol (Mallinckrodt Inc.), a combination of 5mg of oxycodone hydrochloride and 325mg paracetamol per tablet at a minimum interval of 6 hours. After the initial postoperative 48 hours, patients will be allowed to take oral Tylenol as needed (dose as previously described), until the end of the study (3-months follow-up).	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)
Length of Postoperative Anesthesia Care Unit (PACU) stay	Time from arrival at PACU after tracheal extubation to transfer from PACU to the surgical ward (modified Aldrete score ≥9).	Approximately 30 minutes to 2 hours after surgery
Total consumption of remifentanil during surgery	Total remifentanil dosages during surgery	During surgery
Postoperative nausea and vomiting (PONV) score	The Postoperative Nausea and Vomiting (PONV) will be measured using an ordinal scale, with 0 indicating no nausea; 1, mild nausea not requiring treatment; 2, nausea requiring treatment; 3, vomiting.	At 2 hours, 4 hours, 24 hours, 48 hours and 72 hours postoperatively
Rate of steroid-related side effects and complications	Steroid-related side effects (hyperglycemia, gastrointestinal bleeding, gastritis, etc.) or complications including any cardiac, respiratory, renal, neurologic, or infection complications occured during the hospitalization.	Through the whole follow-up, an average of 3 months
Readmission rate within 3 months after spine surgery	Patients readmitted within 3 months after spine surgery	Through the whole follow-up, within 3 months after spine surgery

Collaborators and Investigators

• Sponsor: Fang Luo
• Investigators: Principal Investigator: Fang Luo, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2025
• Primary Completion (Actual): May 10, 2025
• Study Completion (Actual): August 10, 2025

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: January 25, 2025
• First Posted (Actual): January 30, 2025

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 28, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Organic Chemicals; Polycyclic Compounds; Anilides; Amides; Aniline Compounds; Amines; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Ropivacaine; Triamcinolone Acetonide
• Other Study ID Numbers: KY-2019-112-02-4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No