Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery

NCT03242668 | Completed DMC

• 1 other identifier: 103HospitalVMMU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative

Keywords

paravertebral block,PVC,PCA

Outcome Measures

Primary Outcomes (1)

• VAS score at rest and on coughing

  Using VAS scale (Atrazennica)

  72 hours

Secondary Outcomes (5)

• Analgesia effects on respiratory function

  three postoperative consecutive days

• Arterial blood gas values

  three postoperative consecutive days

• The number dermatome inhibition

  three postoperative consecutive days

• Rescue analgesia

  three postoperative consecutive days

• Patient's satisfaction

  three postoperative consecutive days

Other Outcomes (3)

• Side effects and complications

  three postoperative consecutive days

• Heart rate

  three postoperative consecutive days

• Blood pressure

  three postoperative consecutive days

Study Arms (1)

PVB using PVC for PCA in VATS

EXPERIMENTAL

The VATS was performed.Paravertebral space was identified by loss of resistance technique combined with video-assisted inside thoracic space before chest close.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 with background rate 3ml/h, bolus dose 2ml was infused through PVC.

Procedure: VATS; Procedure: PVB using PVC; Drug: PCA

Interventions

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.

Also known as: Video-Assisted Thoracic Surgery

PVB using PVC for PCA in VATS

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.

Also known as: Paravertebral block using paravertebral catheter

PVB using PVC for PCA in VATS

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.

Also known as: Patient controlled analgesia

PVB using PVC for PCA in VATS

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nguyen Trung Kien: lead
• Nguyen Truong Giang, PhD. Associate Prof.: collaborator

Study Sites (1)

Vietnam Military Medical University

Hanoi, Vietnam

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Thoracic Surgery, Video-Assisted; Passive Cutaneous Anaphylaxis; Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Corresponding author,Clinical Research

Model Details: 30 patients, with American Society of Anesthesiologists class I to III risk undergoing elective VATS, aged 32-72 years, scheduled for lung resection surgery , were enrolled in this randomised observer blinded prospective clinical study. 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 for paravertebral block, kyphoscoliosis, presence of acute herpes zoster, chronic pain syndrome, chronic analgesic use and psychiatric disease were excluded from this study.

Study Record Dates

• First Submitted: July 25, 2017
• First Posted: August 8, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: July 1, 2017
• Last Updated: August 8, 2017

Record last verified: 2017-08

Locations

VN (1)