Paravertebral Block for Postoperative Analgesia in Thoracoscopic Surgery

Pain, Postoperative Clinical Trial

Official title:

Patient Controlled Paravertebral Analgesia for Video-assisted Thoracoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242668
• Other study ID #: 103HospitalVMMU
• Status: Completed
• Phase: N/A
• First received: July 25, 2017
• Last updated: August 3, 2017
• Start date: June 1, 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: August 2017
• Source: Vietnam Military Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 1, 2017
• Est. primary completion date: June 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Procedure:
• VATS
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.
• PVB using PVC
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.

Drug:
• PCA
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.

Locations

Country	Name	City	State
Vietnam	Vietnam Military Medical University	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Nguyen Trung Kien	Nguyen Truong Giang, PhD. Associate Prof.

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Side effects and complications	Respiratory depression (respiratory rate < 8 breaths/min), ,confusion, sedation, urinary retention, nausea, vomiting, headache and pruritus was evaluated.	three postoperative consecutive days
Other	Heart rate	Using monitoring (Philips)	three postoperative consecutive days
Other	Blood pressure	Using monitoring (Philips)	three postoperative consecutive days
Primary	VAS score at rest and on coughing	Using VAS scale (Atrazennica)	72 hours
Secondary	Analgesia effects on respiratory function	Using Spirometry (Chestgraph H1 - 105,Japane) to evaluate respiratory index	three postoperative consecutive days
Secondary	Arterial blood gas values	Using Arterial blood gas analysis (STAT Model No.MCP9819-065, Martel Instruments Ltd)	three postoperative consecutive days
Secondary	The number dermatome inhibition	Using pin-prick test	three postoperative consecutive days
Secondary	Rescue analgesia	When VAS score equal to or more than 4 using fentanyl to manage pain	three postoperative consecutive days
Secondary	Patient's satisfaction	Using questionaire with 4 levels :not good,satisfied,good,very good	three postoperative consecutive days