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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04767256
Other study ID # XH20210202
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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