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Clinical Trials/NCT04767256
NCT04767256
Completed
Not Applicable

Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block for Posterior Lumbar Interbody Fusion Surgery

Huazhong University of Science and Technology1 site in 1 country120 target enrollmentMarch 1, 2021

Overview

Phase
Not Applicable
Intervention
Dexamethasone and dexmedetomidine
Conditions
Dexamethasone
Sponsor
Huazhong University of Science and Technology
Enrollment
120
Locations
1
Primary Endpoint
The time to first rescue analgesic request
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Patients having lumbar spinal fusion often complain about severe postoperative pain and postoperative rehabilitation process can be affected negatively. Postoperative pain that cannot be well controlled may lead to delayed mobilization, pulmonary and thromboembolic complications, prolonged hospital stays, and chronic pain syndromes. Pain after spinal surgery can arise from several different tissues, such as the vertebrae, disks, ligaments, dura, facet joint, muscle, fascia, and subcutaneous and cutaneous tissues.

Ultrasound-guided lumbar erector spinae plane block (ESPB) has been shown to reduce postoperative pain in patients undergoing posterior lumbar interbody fusion (PLIF). However, the duration of analgesia after single-shot ESPB with commonly used local anesthetics is reported to be no more than 12 h, which often not long enough to provide satisfactory postoperative pain relief, as the pain typically lasts for several days. Compared with perineural route, intravenous additives to local anesthetics are commonly accepted as its safety and efficiency have been reported. Moreover, co-administration of intravenous dexamethasone and dexmedetomidine significantly prolonged the time to first rescue analgesic request after single-shot interscalene brachial plexus block. However, more data are needed especially for lumbar ESPB.

Registry
clinicaltrials.gov
Start Date
March 1, 2021
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xi Wu

Principal Investigator, Department of Anesthesiology, Union Hospital of Tongji Medical College

Huazhong University of Science and Technology

Eligibility Criteria

Inclusion Criteria

  • Age 18-65 yrs
  • American Society of Anesthesiologists physical statusⅠ-Ⅲ
  • Involvement of ≤3 spinal levels
  • Undergo elective posterior lumbar interbody fusion
  • Informed consent

Exclusion Criteria

  • A known allergy to the drugs being used
  • Pre-existing neuropsychiatric disorders or language barrier
  • Analgesics intake, history of substance abuse
  • Contraindications to peripheral nerve block
  • Acute cerebrovascular disease
  • Severe liver failure
  • Uncontrolled low blood pressure
  • Sinus bradycardia or atrioventricular block

Arms & Interventions

DD group

co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg

Intervention: Dexamethasone and dexmedetomidine

DD group

co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg

Intervention: Ultrasound-guided lumbar erector spinae plane block

DD group

co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg

Intervention: PCIA

D group

intravenous dexmedetomidine 1 ug/kg

Intervention: Dexmedetomidine

D group

intravenous dexmedetomidine 1 ug/kg

Intervention: Ultrasound-guided lumbar erector spinae plane block

D group

intravenous dexmedetomidine 1 ug/kg

Intervention: PCIA

Outcomes

Primary Outcomes

The time to first rescue analgesic request

Time Frame: Up to 48 postoperative hrs

The cumulative opioid consumption

Time Frame: At 24 postoperative hours

Secondary Outcomes

  • Postoperative hospital length of stay(Up to 3 weeks)
  • Adverse events(Up to 48 postoperative hrs)
  • The pain scores determined by the numeric rating scale (NRS, 0-10)(At 6, 12, 18, 24, 30, 36, 42, and 48 hrs after the surgery)
  • Incidence of postoperative nausea and vomiting(Up to 24 postoperative hrs)

Study Sites (1)

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