Clinical trial NCT05693467: Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery
Official title: Preemptive Co-infiltration of Dexamethasone Palmitate Emulsion With Ropivacaine for Postoperative Pain in Patients Undergoing Major Spinal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain, Postoperative
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

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:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.