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

March 26, 2022 updated by: Xi Wu, Huazhong University of Science and Technology

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The cumulative opioid consumption
Time Frame: At 24 postoperative hours
At 24 postoperative hours
The time to first rescue analgesic request
Time Frame: Up to 48 postoperative hrs
Up to 48 postoperative hrs

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Incidence of postoperative nausea and vomiting
Time Frame: Up to 24 postoperative hrs
Up to 24 postoperative hrs
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
At 6, 12, 18, 24, 30, 36, 42, and 48 hrs after the surgery
Postoperative hospital length of stay
Time Frame: Up to 3 weeks
Up to 3 weeks
Adverse events
Time Frame: Up to 48 postoperative hrs
Up to 48 postoperative hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Huazhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 22, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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