Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia

NCT03449563 | Completed

• 1 other identifier: Nerve block
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

thoracic paravertebral block; postoperative analgesia; pulmonary lobectomy

Outcome Measures

Primary Outcomes (3)

• Change in Visual Analogue Score at rest

  Visual 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).

  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

• Change in Visual Analogue Score during coughing

  Visual 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).

  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

• Change in the respiratory rate

  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.

  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 (7)

• Change in Blood pressure

  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

• Change in Heart Rate

  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

• Change in pulse oximetry

  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

• The number of successfully delivered doses of the patient-controlled intravenous analgesia pump

  48 hour after the surgery

• The operating time of thoracic paravertebral block

  From onset the thoracic paravertebral block to 24 hour after the surgery

Study Arms (3)

Placebo group (group G)

PLACEBO COMPARATOR

Other: placebo

Ultrasound-guided TPVB group (group U)

ACTIVE COMPARATOR

Combination Product: Ultrasound-guided TPVB

open TPVB group(group E)

EXPERIMENTAL

Combination Product: Open TPVB

Interventions

Open TPVB 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.

open TPVB group(group E)

Ultrasound-guided TPVB 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.

Ultrasound-guided TPVB group (group U)

placebo OTHER

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

Placebo group (group G)

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kunming Medical University: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Guoliang Zhao

  First Affiliated Hospital of Kunming Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident dictor

Study Record Dates

• First Submitted: February 11, 2018
• First Posted: February 28, 2018
• Study Start: September 1, 2016
• Primary Completion: November 9, 2017
• Study Completion: December 28, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02