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

NCT ID: NCT04767256

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2021-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

DD group

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

Group Type: EXPERIMENTAL

Dexamethasone and dexmedetomidine

Intervention Type: 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.

Ultrasound-guided lumbar erector spinae plane block

Intervention Type: 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

Intervention Type: 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

intravenous dexmedetomidine 1 ug/kg

Group Type: PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Dexmedetomidine

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

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Xi Wu

Principal Investigator, Department of Anesthesiology, Union Hospital of Tongji Medical College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Union Hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

XH20210202

Identifier Type: -

Identifier Source: org_study_id