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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Dexamethasone; Nerve Block
• Intervention / Treatment: Drug: Dexamethasone and dexmedetomidine; Other: Ultrasound-guided lumbar erector spinae plane block; Other: PCIA; Drug: Dexmedetomidine

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DD group; co-administered intravenous dexamethasone 10 mg and dexmedetomidine 1 ug/kg	Drug: Dexamethasone and dexmedetomidine; 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.; Other: Ultrasound-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.; Other: PCIA; 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.
Placebo Comparator: D group; intravenous dexmedetomidine 1 ug/kg	Other: Ultrasound-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.; Other: PCIA; 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.; Drug: Dexmedetomidine; Intravenous dexmedetomidine 1 ug/kg was infused after induction of general anaesthesia over a 30-min period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The cumulative opioid consumption	At 24 postoperative hours
The time to first rescue analgesic request	Up to 48 postoperative hrs

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative nausea and vomiting	Up to 24 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
Postoperative hospital length of stay	Up to 3 weeks
Adverse events	Up to 48 postoperative hrs

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): August 22, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: February 19, 2021
• First Submitted That Met QC Criteria: February 22, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 26, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexamethasone; Dexmedetomidine
• Other Study ID Numbers: XH20210202

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No