Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery

NCT05693467 | Completed Phase 4 DMC

• 1 other identifier: KY-2019-112-02-3
• Study Type: interventional
• Target: 124
• 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. Dexamethasone as an adjunctive infiltration to local anesthesia (LA) presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis showed that the additional analgesic effect of dexamethasone in incision/wound infiltration was only statistically significant, but not clinically significant, and the overall benefits were marginal. Compared with dexamethasone, dexamethasone palmitate emulsion (DXP) is a targeted lipo-steroid with stronger anti-inflammatory effect, longer-acting duration and fewer adverse effects. To date, no studies have evaluated the additive analgesia effects of DXP on incision infiltration in major spinal surgery. The purpose of this trial is to determine whether preemptive co-infiltration of DXP emulsion 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)

The dexamethasone palmitate emulsion(DXP) plus ropivacaine group

EXPERIMENTAL

The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine.

Drug: Dexamethasone palmitate emulsion(DXP) 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

Dexamethasone palmitate emulsion(DXP) plus ropivacaine DRUG

The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of ropivacaine and dexamethasone palmitate emulsion(DXP). For local infiltration, a total of 30mL solution will be prepared for each group, which will include 2mL of DXP(4mg per 1mL) added to 20.5 mL of saline and 7.5mL of 1% ropivacaine added to 15mL of saline for Group A . 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.

Also known as: DXP plus ropivacaine

The dexamethasone palmitate emulsion(DXP) 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 7.5mL of ropivacaine added to 22.5mL of saline for Group B . 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 - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-64 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

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100070, China

Location

Related Publications (8)

• Lamperti M, Tufegdzic B, Avitsian R. Management of complex spine surgery. Curr Opin Anaesthesiol. 2017 Oct;30(5):551-556. doi: 10.1097/ACO.0000000000000494.

  PMID: 28731875 BACKGROUND

• Kjaergaard M, Moiniche S, Olsen KS. Wound infiltration with local anesthetics for post-operative pain relief in lumbar spine surgery: a systematic review. Acta Anaesthesiol Scand. 2012 Mar;56(3):282-90. doi: 10.1111/j.1399-6576.2011.02629.x. Epub 2012 Jan 19.

  PMID: 22260370 BACKGROUND

• Bai JW, An D, Perlas A, Chan V. Adjuncts to local anesthetic wound infiltration for postoperative analgesia: a systematic review. Reg Anesth Pain Med. 2020 Aug;45(8):645-655. doi: 10.1136/rapm-2020-101593. Epub 2020 May 30.

  PMID: 32474417 BACKGROUND

• Shrestha N, Han B, Wang X, Jia W, Luo F. Methylprednisolone as an Adjunct to Local Infiltration on Laminoplasty or Laminectomy before Wound Closure: A Randomized Controlled Trial. Pain Res Manag. 2022 Aug 3;2022:2274934. doi: 10.1155/2022/2274934. eCollection 2022.

  PMID: 35966574 BACKGROUND

• Ye X, Ren YF, Hu YC, Tan SY, Jiang H, Zhang LF, Shi W, Wang YT. Dexamethasone Does Not Provide Additional Clinical Analgesia Effect to Local Wound Infiltration: A Comprehensive Systematic Review and Meta-Analysis. Adv Wound Care (New Rochelle). 2023 Jan;12(1):1-14. doi: 10.1089/wound.2021.0163. Epub 2022 Mar 1.

  PMID: 35081741 BACKGROUND

• Zhao C, Wang S, Pan Y, Ji N, Luo F. Pre-Emptive Incision-Site Infiltration with Ropivacaine Plus Dexamethasone for Postoperative Pain After Supratentorial Craniotomy: A Prospective Randomized Controlled Trial. J Pain Res. 2021 Apr 19;14:1071-1082. doi: 10.2147/JPR.S300943. eCollection 2021.

  PMID: 33907455 BACKGROUND

• Han X, Ren T, Wang Y, Ji N, Luo F. Postoperative Analgesic Efficacy and Safety of Ropivacaine Plus Diprospan for Preemptive Scalp Infiltration in Patients Undergoing Craniotomy: A Prospective Randomized Controlled Trial. Anesth Analg. 2022 Dec 1;135(6):1253-1261. doi: 10.1213/ANE.0000000000005971. Epub 2022 Mar 21.

  PMID: 35313321 BACKGROUND

• Yu B, Wang B, Shrestha N, Luo F. Pre-emptive coinfiltration of dexamethasone palmitate emulsion with ropivacaine for postoperative pain in patients undergoing major spine surgery: a study protocol for a prospective, randomised controlled, multicentre trial. BMJ Open. 2023 May 24;13(5):e072162. doi: 10.1136/bmjopen-2023-072162.

  PMID: 37225277 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

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: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Day Surgery and Pain Management

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 23, 2023
• Study Start: March 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

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

Locations

CN (1)