Preemptive Co-infiltration of Dexamethasone Palmitate With Ropivacaine for Postoperative Pain in Major Spinal Surgery
NCT ID: NCT05693467
Last Updated: 2024-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
124 participants
INTERVENTIONAL
2023-03-01
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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The dexamethasone palmitate emulsion(DXP) plus ropivacaine group
The local infiltration solution in the dexamethasone palmitate emulsion(DXP) plus ropivacaine group will consist of dexamethasone palmitate emulsion(DXP) and ropivacaine.
Dexamethasone palmitate emulsion(DXP) plus ropivacaine
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.
The ropivacaine alone group
The local infiltration solution in the ropivacaine alone group will consist of ropivacaine alone.
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 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.
Interventions
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Dexamethasone palmitate emulsion(DXP) plus ropivacaine
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.
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
64 Years
ALL
No
Sponsors
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Beijing Tiantan Hospital
OTHER
Responsible Party
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Fang Luo
Director of Department of Day Surgery and Pain Management
Principal Investigators
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Fang Luo
Role: PRINCIPAL_INVESTIGATOR
Beijing Tiantan Hospital
Locations
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Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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KY-2019-112-02-3
Identifier Type: -
Identifier Source: org_study_id
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