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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04767256
Enrollment
120
Registered
2021-02-23
Start date
2021-03-01
Completion date
2021-12-30
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexamethasone, Dexmedetomidine, Nerve Block

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.

Interventions

General anesthesia was induced with sufentanil 0.5-0.8 ug/kg, propofol 1.5-2.0 mg/kg, and rocuronium 0.5-1.0 mg/kg. Intravenous dexamethasone 10 mg was injected and a 50-ml syringe containing dexmedetomidine 1 ug/kg in 0.9% saline was infused after induction of general anaesthesia over a 30-min period. Anesthesia was maintained by remifentanil and sevoflurane to keep the Narcotrend index reading between 40 and 60.

DRUGDexmedetomidine

Intravenous dexmedetomidine 1 ug/kg was infused after induction of general anaesthesia over a 30-min period.

OTHERUltrasound-guided lumbar erector spinae plane block

The probe was installed in the sagittal axis in the midline at the L3 vertebral level. The spinous processes were first visualized, after which the probe was lateralized, and the transverse processes and the erector spinae muscle were visualized approximately 3 cm laterally to the midline. The needle was advanced between the transverse process and the deep fascia of the erector spinae muscle from the caudal to the cranial using in-plane technique. The location of the needle was confirmed with 2mL saline solution, after which 20 mL of 0.4% ropivacaine was administered.

OTHERPCIA

Intravenous PCA included 0.9% saline with sufentanil and was programmed to run at 2ml with a 1-ml bolus dose and a 10-min lockout time. The patients with VAS more than 4 despite using intravenous PCA were treated with rescue analgesics comprising intravenous parecoxib.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frame
The cumulative opioid consumptionAt 24 postoperative hours
The time to first rescue analgesic requestUp to 48 postoperative hrs

Secondary

MeasureTime frame
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 vomitingUp to 24 postoperative hrs
Postoperative hospital length of stayUp to 3 weeks
Adverse eventsUp to 48 postoperative hrs

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026