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

Dexmedetomidine Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04767256
• Other study ID #: XH20210202
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2022
• Source: Huazhong University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 30, 2021
• Est. primary completion date: August 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Age 18-65 yrs

2. American Society of Anesthesiologists physical status?-?

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

Related Conditions & MeSH terms

• Dexamethasone
• Dexmedetomidine
• Nerve Block

Intervention

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

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 ?rst 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
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.

Locations

Country	Name	City	State
China	Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The cumulative opioid consumption		At 24 postoperative hours
Primary	The time to ?rst rescue analgesic request		Up to 48 postoperative hrs
Secondary	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
Secondary	Incidence of postoperative nausea and vomiting		Up to 24 postoperative hrs
Secondary	Postoperative hospital length of stay		Up to 3 weeks
Secondary	Adverse events		Up to 48 postoperative hrs