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Completed

NCT Number: NCT03242668

Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery

To access the analgesic efficacy of patient controlled thoracic paravertebral analgesia.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vietnam Military Medical University

Hanoi, Vietnam

About this study

The study was carried out on thirty patients who underwent video-assisted thoracic surgery.Paravertebral space was identified by loss of resistance technique under video-assisted inside thoracic space before chest close.Initiated dose of 0.3ml/kg of bupivacaine 0.125%+fentanyl 2 mcg/ml was administered then continued patient-controlled analgesia with background rate 3ml/h, bolus dose 2ml, lockout interval 10 minutes. Postoperative pain was accessed by Visual Analogue Scale at rest and on coughing; monitor the heart rate, blood pressure, respiratory rate, SpO2, arterial blood gas and spirometry in three postoperative consecutive days.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery.

Exclusion criteria

  • Patients who refused to participate, less than 18 years of age, ASA physical status 3 or more,, allergy to any of the study drugs, patients having any contraindication to placement of PVB, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease.

Treatment and study plan

VATS

Procedure

General anesthesia was induced with 2.0 mg/kg of propofol, 2.0 mg/kg of fentanyl, and 1.0 mg kg/1 of rocuronium and maintained with continuous infusion 6-12mg/kg/h of propofol,injected 2.0 mg/kg of fentanyl and 0.15 mg/ kg of rocuronium every 30 minutes . All patients were intubated with a double-lumen endobronchial tube for one-lung ventilation.The VATS (Video-Assisted Thoracic Surgery) was performed.

Other names: Video-Assisted Thoracic Surgery

PVB using PVC

Procedure

At the end of the surgery, the upper edge of the spinous process of the thoracic vertebral body was recognized. With an epidural needle (Tuohy 22 G; Braun, Melsungen, Germany), the injection point was punctured 2 cm lateral to the midline. The paravertebral space was entered by advancing the Tuohy needle over the superior border of the transverse process. Once in the right place, the PVC was placed through the needle, checking the tip remained placed when removing the needle. The advance of the needle and the entering of the catheter into the paravertebral space were verified all the time by the surgeon using the camera. The PVC (Paravertebral Catheter ) was inserted at this point preversed at this area.

Other names: Paravertebral block using paravertebral catheter

PCA

Drug

PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with background rate 3ml/h, bolus dose 2ml was infused through PVC.

Other names: Patient controlled analgesia

Primary outcomes

  1. VAS score at rest and on coughing

    Time frame: 72 hours

    Using VAS scale (Atrazennica)

Secondary outcomes

  1. Analgesia effects on respiratory function

    Time frame: three postoperative consecutive days

    Using Spirometry (Chestgraph H1 - 105,Japane) to evaluate respiratory index

  2. Arterial blood gas values

    Time frame: three postoperative consecutive days

    Using Arterial blood gas analysis (STAT Model No.MCP9819-065, Martel Instruments Ltd)

  3. The number dermatome inhibition

    Time frame: three postoperative consecutive days

    Using pin-prick test

  4. Rescue analgesia

    Time frame: three postoperative consecutive days

    When VAS score equal to or more than 4 using fentanyl to manage pain

  5. Patient's satisfaction

    Time frame: three postoperative consecutive days

    Using questionaire with 4 levels :not good,satisfied,good,very good

Other outcomes

  1. Side effects and complications

    Time frame: three postoperative consecutive days

    Respiratory depression (respiratory rate < 8 breaths/min), ,confusion, sedation, urinary retention, nausea, vomiting, headache and pruritus was evaluated.

  2. Heart rate

    Time frame: three postoperative consecutive days

    Using monitoring (Philips)

  3. Blood pressure

    Time frame: three postoperative consecutive days

    Using monitoring (Philips)

Sponsors and collaborators

Lead sponsor

Nguyen Trung Kien

Other

Collaborators

  • Nguyen Truong Giang, PhD. Associate Prof.

Registry information

Official study title

Patient Controlled Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Aug 8, 2017
Registry last updated
Aug 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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