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

NCT06801587 | Completed Phase 4 DMC

• 1 other identifier: KY-2019-112-02-4
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Postoperative

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• The cumulative consumption of sufentanil via PCA pump between 24 hours and 48 hours postoperatively.

  Between 24 hours and 48 hours after spinal surgery

• Number of patients without PCA press button

  Within 48 hours after spinal surgery

• The time of first PCA demand

  Within 48 hours after spinal surgery

• The total number of PCA presses including both valid and invalid presses

  Within 48 hours after spinal surgery

• Postoperative visual analogue scale (VAS) score during movement(VASm)

  At 2 hours, 4 hours, 24 hours, 48 hours, 72 hours, 1 week, 2 weeks, 3 weeks, 1 month and 3 months postoperatively

Study Arms (2)

Triamcinolone acetonide plus ropivacaine group

EXPERIMENTAL

The local infiltration solution in the triamcinolone acetonide plus ropivacaine group will consist of triamcinolone acetonide and ropivacaine.

Drug: Triamcinolone acetonide plus ropivacaine

The ropivacaine alone group

ACTIVE COMPARATOR

The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.

Drug: Ropivacaine alone

Interventions

Triamcinolone acetonide plus ropivacaine DRUG

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.

Triamcinolone acetonide plus ropivacaine group

Ropivacaine alone DRUG

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.

The ropivacaine alone group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fang Luo: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

MeSH Terms

Conditions

Pain

Interventions

Triamcinolone Acetonide; Ropivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Fang Luo

  Beijing Tiantan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Department of Pain Management

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: January 30, 2025
• Study Start: February 5, 2025
• Primary Completion: May 10, 2025
• Study Completion: August 10, 2025
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)