Clinical trial NCT03449563: Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia
Official title: Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia in Patients Undergoing Open Pulmonary Lobectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Keywords: thoracic paravertebral block
postoperative analgesia
pulmonary lobectomy
Lead sponsor: Kunming Medical University
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 90
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia. Then, A total of 90 patients with American Society of Anesthesiologists (ASA) scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total intravenous anaesthesia, were randomly divided into PCIA group (group G), Ultrasound-guided TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group E).Finally, the study find that Open TPVB can provided satisfactory analgesia for patients undergoing open pulmonary lobectomy under general anesthesia, and the analgesia efficacy was equivalent to the TPVB under ultrasound guidance,which should be popularized.

Detailed description: Purpose: The study was aimed to assess the effects of open thoracic paravertebral block on postoperative analgesia in patients undergoing open pulmonary lobectomy under general anesthesia.

Methods: A total of 90 patients with American Society of Anesthesiologists (ASA) scores of Ⅰ or Ⅱ, scheduled for open pulmonary lobectomy under propofol - remifentanil total intravenous anaesthesia, were randomly divided into 3 groups (n = 30 each) by using a random number table: PCIA group (group G), Ultrasound-guided TPVB combined with PCIA group (group U), and open TPVB combined with PCIA group (group E). In group G, patients were received PCIA after the surgery. In group U, TPVB was performed on the operated side under ultrasound guidance with 0.25% ropivacaine 30 ml combined with the PCIA after the surgery. In group E, the TPVB was performed under the direct vision with 0.25% ropivacaine 30 ml combined with the PCIA. The Visual Analogue Score (VAS) at rest and during coughing, the sensory nerve block segment, as well as the respiratory rate were measured and recorded at different time-points. Furthermore, the hemodynamic vital signs at different time - points, the number of successfully delivered doses 48 h after the surgery, as well as the incidence of postoperative complications were also recorded and analyzed.

Eligibility criteria: Inclusion Criteria:

* with American Society of Anesthesiologists physical status Ⅰor Ⅱ
* aged 35 - 75 years old
* with body mass index of 20 - 25 kg／m2,
* scheduled for open pulmonary lobectomy under general anaesthesia at the First Affiliated Hospital of Kunming Medical University

Exclusion Criteria:

* cardiovascular and/or cerebrovascular disease;
* diabetes; pre-existing liver, lung or kidney dysfunction;
* bilateral surgery; take operations again within 48 h after the surgery;
* with serious pulmonary infection and coagulation dysfunction

Primary outcomes:
measure: Change in Visual Analogue Score at rest
timeFrame: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation
measure: Change in Visual Analogue Score during coughing
timeFrame: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation
measure: Change in the respiratory rate
timeFrame: 30 minutes after extubation,1 hour after extubation, 2 hour after extubation, 4 hour after extubation, 6 hour after extubation, 8 hour after extubation, 12 hour after extubation, 24 hour after extubation, 48 hour after extubation.
Secondary outcomes:
measure: Change in Blood pressure
timeFrame: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
measure: Change in Heart Rate
timeFrame: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
measure: Change in pulse oximetry
timeFrame: immediately after the nerve block, 5 minutes after the nerve block, 10 minutes after the nerve block, 15 minutes after the nerve block, 20 minutes after the nerve block, 30 minutes after the nerve block, 45 minutes after the nerve block, 1 hour after the
measure: The number of successfully delivered doses of the patient-controlled intravenous analgesia pump
timeFrame: 48 hour after the surgery
measure: The operating time of thoracic paravertebral block
timeFrame: From onset the thoracic paravertebral block to 24 hour after the surgery
measure: The degree of parents'satisfaction with analgesia
timeFrame: up to three days after the surgery
measure: The postoperative complications like agitation, respiratory depression, nausea, vomiting
timeFrame: up to three days after the surgery
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Kunming Medical University
name: Guoliang Zhao
role: PRINCIPAL_INVESTIGATOR
References: