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

Overview

Journal BMJ Open

Specialty General Medicine

Date 2023 May 24

PMID 37225277

Authors

Bin Yu

Baoguo Wang

Niti Shrestha

Fang Luo

Affiliations

Soon will be listed here.

Abstract

Introduction: Patients undergoing major spine surgery usually experience moderate-to-severe postoperative pain. It has been shown that dexamethasone as an adjunct to local anaesthesia (LA) infiltration presented a superior analgesic benefit compared with LA alone in various types of surgeries. However, a recent meta-analysis reported that the overall benefits of dexamethasone infiltration were marginal. Dexamethasone palmitate (DXP) emulsion is a targeted liposteroid. Compared with dexamethasone, DXP has a stronger anti-inflammatory effect, longer duration of action and fewer adverse effects. We hypothesised that the additive analgesic effects of DXP on local incisional infiltration in major spine surgery may have better postoperative analgesic effect, compared with local anaesthetic alone. However, no study has evaluated this so far. The purpose of this trial is to determine whether pre-emptive coinfiltration of DXP emulsion and ropivacaine at surgical site incision will further reduce postoperative opioid requirements and pain scores after spine surgery than that with ropivacaine alone.

Methods And Analysis: This is a prospective, randomised, open-label, blinded endpoint, multicentre study. 124 patients scheduled for elective laminoplasty or laminectomy with no more than three levels will be randomly allocated in a 1:1 ratio into two groups: the intervention group will receive local incision site infiltration with ropivacaine plus DXP; the control group will receive infiltration with ropivacaine alone. All participants will complete a 3 months follow-up. The primary outcome will be the cumulative sufentanil consumption within 24 hours after surgery. The secondary outcomes will include further analgesia outcome assessments, steroid-related side effects and other complications, within the 3 months follow-up period.

Ethics And Dissemination: This study protocol has been approved by the Institutional Review Board of Beijing Tiantan Hospital (KY-2019-112-02-3). All participants will provide a written informed consent. The results will be submitted for publication in a peer-reviewed journals.

Trial Registration Number: NCT05693467.

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References

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; 2022:2274934. PMC: 9366200. DOI: 10.1155/2022/2274934. View

Waelkens P, Alsabbagh E, Sauter A, Joshi G, Beloeil H . Pain management after complex spine surgery: A systematic review and procedure-specific postoperative pain management recommendations. Eur J Anaesthesiol. 2021; 38(9):985-994. PMC: 8373453. DOI: 10.1097/EJA.0000000000001448. View

Yamaguchi D, Morisaki T, Sakata Y, Mizuta Y, Nagatsuma G, Inoue S . Usefulness of discharge standards in outpatients undergoing sedative endoscopy: a propensity score-matched study of the modified post-anesthetic discharge scoring system and the modified Aldrete score. BMC Gastroenterol. 2022; 22(1):445. PMC: 9635164. DOI: 10.1186/s12876-022-02549-7. View

Reddi D, Curran N . Chronic pain after surgery: pathophysiology, risk factors and prevention. Postgrad Med J. 2014; 90(1062):222-7. DOI: 10.1136/postgradmedj-2013-132215. View

Gurbet A, Bekar A, Bilgin H, Korfali G, Yilmazlar S, Tercan M . Pre-emptive infiltration of levobupivacaine is superior to at-closure administration in lumbar laminectomy patients. Eur Spine J. 2008; 17(9):1237-41. PMC: 2527409. DOI: 10.1007/s00586-008-0676-z. View

Tuna T, Boz S, Van Obbergh L, Lubansu A, Engelman E . Comparison of the Pain Sensitivity Questionnaire and the Pain Catastrophizing Scale in Predicting Postoperative Pain and Pain Chronicization After Spine Surgery. Clin Spine Surg. 2018; 31(9):E432-E440. DOI: 10.1097/BSD.0000000000000694. View

Steel T, Jones R, Crossman J, Sheehy J, Bentivoglio P, Pell M . Intraoperative wound infiltration with bupivacaine in patients undergoing lumbar spine surgery. J Clin Neurosci. 2008; 5(3):298-303. DOI: 10.1016/s0967-5868(98)90065-0. View

Shrestha N, Wu L, Wang X, Jia W, Luo F . Preemptive Infiltration with Betamethasone and Ropivacaine for Postoperative Pain in Laminoplasty or Laminectomy (PRE-EASE): study protocol for a randomized controlled trial. Trials. 2020; 21(1):381. PMC: 7201781. DOI: 10.1186/s13063-020-04308-z. View

Choi E, Kim D, Han W, Lee H, Kang I, Nahm F . Non-Particulate Steroids (Betamethasone Sodium Phosphate, Dexamethasone Sodium Phosphate, and Dexamethasone Palmitate) Combined with Local Anesthetics (Ropivacaine, Levobupivacaine, Bupivacaine, and Lidocaine): A Potentially Unsafe Mixture. J Pain Res. 2021; 14:1495-1504. PMC: 8166310. DOI: 10.2147/JPR.S311573. View

10.

Tsaousi G, Tsitsopoulos P, Pourzitaki C, Palaska E, Badenes R, Bilotta F . Analgesic Efficacy and Safety of Local Infiltration Following Lumbar Decompression Surgery: A Systematic Review of Randomized Controlled Trials. J Clin Med. 2021; 10(24). PMC: 8706068. DOI: 10.3390/jcm10245936. View

11.

Ozyilmaz K, Ayoglu H, Okyay R, Yurtlu S, Koksal B, Hanci V . Postoperative analgesic effects of wound infiltration with tramadol and levobupivacaine in lumbar disk surgeries. J Neurosurg Anesthesiol. 2012; 24(4):331-5. DOI: 10.1097/ANA.0b013e3182611a1d. View

12.

Perera A, Chari A, Kostusiak M, Khan A, Luoma A, Casey A . Intramuscular Local Anesthetic Infiltration at Closure for Postoperative Analgesia in Lumbar Spine Surgery: A Systematic Review and Meta-Analysis. Spine (Phila Pa 1976). 2017; 42(14):1088-1095. DOI: 10.1097/BRS.0000000000001443. View

13.

Lorscheider M, Tsapis N, Ur-Rehman M, Gaudin F, Stolfa I, Abreu S . Dexamethasone palmitate nanoparticles: An efficient treatment for rheumatoid arthritis. J Control Release. 2019; 296:179-189. DOI: 10.1016/j.jconrel.2019.01.015. View

14.

Pugely A, Martin C, Gao Y, Mendoza-Lattes S . Causes and risk factors for 30-day unplanned readmissions after lumbar spine surgery. Spine (Phila Pa 1976). 2014; 39(9):761-8. DOI: 10.1097/BRS.0000000000000270. View

15.

Evaristo-Mendez G, Alba-Garcia J, Sahagun-Flores J, Ventura-Sauceda F, Mendez-Ibarra J, Sepulveda-Castro R . [Analgesic efficacy of the incisional infiltration of ropivacaine vs ropivacaine with dexamethasone in the elective laparoscopic cholecystectomy]. Cir Cir. 2014; 81(5):383-93. View

16.

Gurbet A, Bekar A, Bilgin H, Ozdemir N, Kuytu T . Preemptive wound infiltration in lumbar laminectomy for postoperative pain: comparison of bupivacaine and levobupivacaine. Turk Neurosurg. 2014; 24(1):48-53. DOI: 10.5137/1019-5149.JTN.8431-13.0. View

17.

Hellmich D, Kob A, Deubler R, Schroder C, Rose P, Elsasser R . Acute Treatment of Facet Syndrome by CT-Guided Injection of Dexamethasone-21-Palmitate Alone and in Combination with Mepivacaine. Clin Drug Investig. 2007; 24(10):559-67. DOI: 10.2165/00044011-200424100-00001. View

18.

Saha B, Milman N . Short Review of Liposteroid: A Novel Targeted Glucocorticoid Preparation for Treatment of Autoimmune and Inflammatory Diseases. Prague Med Rep. 2021; 122(4):257-268. DOI: 10.14712/23362936.2021.23. View

19.

Brown E, Pavone K, Naranjo M . Multimodal General Anesthesia: Theory and Practice. Anesth Analg. 2018; 127(5):1246-1258. PMC: 6203428. DOI: 10.1213/ANE.0000000000003668. View

20.

Bianconi M, Ferraro L, Ricci R, Zanoli G, Antonelli T, Giulia B . The pharmacokinetics and efficacy of ropivacaine continuous wound instillation after spine fusion surgery. Anesth Analg. 2003; 98(1):166-172. DOI: 10.1213/01.ANE.0000093310.47375.44. View