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Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia

Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia in Patients Undergoing Open Pulmonary Lobectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03449563
Enrollment
90
Registered
2018-02-28
Start date
2016-09-01
Completion date
2017-12-28
Last updated
2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

thoracic paravertebral block, postoperative analgesia, pulmonary lobectomy

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.

Interventions

COMBINATION_PRODUCTOpen TPVB

In Group E,the thoracic paravertebral block was performed under the direct vision with 0.25% ropivacaine 30 ml,and the Patient-controlled intravenous analgesia was administer after the surgery.

COMBINATION_PRODUCTUltrasound-guided TPVB

In Group U, thoracic paravertebral block was performed on the operated side under ultrasound guidance with 0.25% ropivacaine 30 ml,and the Patient-controlled intravenous analgesia was administer after the surgery.

OTHERplacebo

In Group G,patients were just received Patient-controlled intravenous analgesia after the surgery.

Sponsors

Kunming Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Visual Analogue Score at rest30 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 extubationVisual Analogue Score at rest was recorded at 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. And the Visual Analogue Score was ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable).
Change in Visual Analogue Score during coughing30 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 extubationVisual Analogue Score (VAS) during coughing was recorded 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. And the Visual Analogue Score was ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable).
Change in the respiratory rate30 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.The respiratory rate was recorded at 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

MeasureTime frameDescription
The number of successfully delivered doses of the patient-controlled intravenous analgesia pump48 hour after the surgeryThe number of successfully delivered doses of the patient-controlled intravenous analgesia pump was recorded 48 hour after the surgery.
The operating time of thoracic paravertebral blockFrom onset the thoracic paravertebral block to 24 hour after the surgery
Change in Blood pressureimmediately 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 theThe blood pressure was recorded at the time points of 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 nerve block, 2 hour after the nerve block.
The postoperative complications like agitation, respiratory depression, nausea, vomitingup to three days after the surgeryThe postoperative complications like agitation, respiratory depression, nausea, vomiting were recorded three days after the surgery.
The degree of parents'satisfaction with analgesiaup to three days after the surgeryThe degree of parents'satisfaction with analgesia was recorded three days after the surgery.
Change in Heart Rateimmediately 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 theThe Heart Rate was recorded at the time points of 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 nerve block, 2 hour after the nerve block.
Change in pulse oximetryimmediately 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 theThe pulse oximetry was recorded at the time points of 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 nerve block, 2 hour after the nerve block.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026