Comparison of the Duration of Ropivacaine Combined With Dexmedetomidine or Dexamethasone on Paravertebral Block

China Medical University, China

Status and phase: Completed; Phase 4

Conditions: Lung Cancer

Treatments: Drug: control group; Drug: dexamethasone group; Drug: Dexmedetomidine Group

Study type: Interventional

Funder types: Other

Identifiers

NCT03570645

20180616

Details and patient eligibility

About

This study was a prospective, randomized, controlled, and double-blind trial. Major assessments were made during the operation and 48 h postoperatively.

Full description

The prime outcomes were the time in minutes from leave the postoperative care unit to the first patient-controlled intravenous analgesia press.The secondary outcomes were to compare the following: (1)blood concentrations of ropivacaine was measured at 0.5 h, 1 h, 2 h, 3 h, and 24 h after paravertebral nerve block; and (2) the patient's intraoperative opioid use, phenylephrine use, fluid intake, urine output, dry mouth score, and 24 h and 48 h visual analogue scale.

Enrollment: 154 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• (1) age 18 to 65 years,
• (2) scheduled to undergo video-assisted thoracic surgery,
• (3) American Society of Anesthesiologists risk classification I-II.

Exclusion criteria

• (1) patient refusal;
• (2) known hypersensitivity to the study medication (ropivacaine);
• (3) long-term use of opioids;
• (4) liver or renal insufficiency;
• (5) a history of psychiatric or neurological disease;
• (6) deafness;
• (7) regular use of acetaminophen, nonsteroidal anti-inflammatory drugs, corticosteroids, or antiemetics; and
• (8) a preoperative Pittsburgh Sleep Quality Index (PSQI) global score higher than 6.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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154 participants in 3 patient groups

dexmedetomidine group

Experimental group

Description:

thoracic paravertebral blocks using a combination of ropivacaine and dexmedetomidine 100 ug every time

Treatment:

Drug: Dexmedetomidine Group

dexamethasone Group

Experimental group

Description:

thoracic paravertebral blocks using a combination of ropivacaine and dexamethasone 10 mg every time

Treatment:

Drug: dexamethasone group

control group

Sham Comparator group

Description:

thoracic paravertebral blocks using only ropivacaine

Treatment:

Drug: control group