Effects of Open Thoracic Paravertebral Block on Postoperative Analgesia

Kunming Medical University

Status: Completed

Conditions: Lung Cancer

Treatments: Combination Product: Ultrasound-guided TPVB; Combination Product: Open TPVB; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03449563

Nerve block

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

Placebo group (group G)

Placebo Comparator group

Treatment:

Other: placebo

Ultrasound-guided TPVB group (group U)

Active Comparator group

Treatment:

Combination Product: Ultrasound-guided TPVB

open TPVB group(group E)

Experimental group

Treatment:

Combination Product: Open TPVB