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Completed

NCT Number: NCT04767256

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

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.

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Key information

Conditions

Dexamethasone Dexmedetomidine Nerve Block

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Union Hospital

Wuhan, Hubei, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Dexmedetomidine

Drug

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

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.

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.

Primary outcomes

  1. The cumulative opioid consumption

    Time frame: At 24 postoperative hours

  2. The time to first rescue analgesic request

    Time frame: Up to 48 postoperative hrs

Secondary outcomes

  1. The pain scores determined by the numeric rating scale (NRS, 0-10)

    Time frame: At 6, 12, 18, 24, 30, 36, 42, and 48 hrs after the surgery

  2. Incidence of postoperative nausea and vomiting

    Time frame: Up to 24 postoperative hrs

  3. Postoperative hospital length of stay

    Time frame: Up to 3 weeks

  4. Adverse events

    Time frame: Up to 48 postoperative hrs

Sponsors and collaborators

Lead sponsor

Huazhong University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 23, 2021
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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