Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block

Not Applicable

Completed

• Conditions: Dexamethasone; Dexmedetomidine; Nerve Block
• Interventions: Drug: Dexamethasone and dexmedetomidine; Drug: Dexmedetomidine; Other: Ultrasound-guided lumbar erector spinae plane block; Other: PCIA

• Registration Number: NCT04767256
• Lead Sponsor: Huazhong University of Science and Technology

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-02-19
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2021-03-01
• Primary Completion: 2021-08-22
• Study Completion: 2021-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-26
• Last Update Posted: 2022-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DD group	Dexamethasone and dexmedetomidine	co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg
DD group	Ultrasound-guided lumbar erector spinae plane block	co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg
D group	Ultrasound-guided lumbar erector spinae plane block	intravenous dexmedetomidine 1 ug/kg
DD group	PCIA	co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg
D group	PCIA	intravenous dexmedetomidine 1 ug/kg
D group	Dexmedetomidine	intravenous dexmedetomidine 1 ug/kg

Primary Outcome Measures

Name	Time	Method
The time to first rescue analgesic request	Up to 48 postoperative hrs
The cumulative opioid consumption	At 24 postoperative hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Union Hospital; 🇨🇳 Wuhan, Hubei, China