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

NCT04767256 | Completed

• 1 other identifier: XH20210202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexamethasone; Dexmedetomidine; Nerve Block

Outcome Measures

Primary Outcomes (2)

• The cumulative opioid consumption

  At 24 postoperative hours

• The time to first rescue analgesic request

  Up to 48 postoperative hrs

Secondary Outcomes (4)

• 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

• Postoperative hospital length of stay

  Up to 3 weeks

• Adverse events

  Up to 48 postoperative hrs

Study Arms (2)

DD group

EXPERIMENTAL

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

Drug: Dexamethasone and dexmedetomidine; Other: Ultrasound-guided lumbar erector spinae plane block; Other: PCIA

D group

PLACEBO COMPARATOR

intravenous dexmedetomidine 1 ug/kg

Drug: Dexmedetomidine; Other: Ultrasound-guided lumbar erector spinae plane block; Other: PCIA

Interventions

Dexamethasone and dexmedetomidine DRUG

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.

DD group

Dexmedetomidine DRUG

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

D group

Ultrasound-guided lumbar erector spinae plane block OTHER

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.

D group; DD group

PCIA OTHER

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.

D group; DD group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

Dexamethasone; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology, Union Hospital of Tongji Medical College

Study Record Dates

• First Submitted: February 19, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: August 22, 2021
• Study Completion: December 30, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)