Clinical trial NCT04767256: Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block
Official title: Intravenous Dexamethasone and Dexmedetomidine on the Analgesic Efficacy of Erector Spinae Plane Block for Posterior Lumbar Interbody Fusion Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dexamethasone
Dexmedetomidine
Nerve Block
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2021-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The cumulative opioid consumption
timeFrame: At 24 postoperative hours
measure: The time to ﬁrst rescue analgesic request
timeFrame: Up to 48 postoperative hrs
Secondary outcomes:
measure: The pain scores determined by the numeric rating scale (NRS, 0-10)
timeFrame: At 6, 12, 18, 24, 30, 36, 42, and 48 hrs after the surgery
measure: Incidence of postoperative nausea and vomiting
timeFrame: Up to 24 postoperative hrs
measure: Postoperative hospital length of stay
timeFrame: Up to 3 weeks
measure: Adverse events
timeFrame: Up to 48 postoperative hrs
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital
state: Hubei
Study officials:
References: