Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia

NCT ID: NCT03449563

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-12-28

Brief Summary

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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

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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.

Conditions

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Lung Cancer

Keywords

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thoracic paravertebral block postoperative analgesia pulmonary lobectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Placebo group (group G)

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

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

Ultrasound-guided TPVB group (group U)

Group Type ACTIVE_COMPARATOR

Ultrasound-guided TPVB

Intervention Type COMBINATION_PRODUCT

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.

open TPVB group(group E)

Group Type EXPERIMENTAL

Open TPVB

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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Open 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.

Intervention Type COMBINATION_PRODUCT

Ultrasound-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.

Intervention Type COMBINATION_PRODUCT

placebo

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kunming Medical University

OTHER

Sponsor Role lead

Responsible Party

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Wenya Bai

Resident dictor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Guoliang Zhao

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital of Kunming Medical University

Other Identifiers

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Nerve block

Identifier Type: -

Identifier Source: org_study_id