Comparison of Efficacy of Paravertebral and Epidural Analgesia After Videothoracoscopic Lung Lobectomy

Lung Cancer Clinical Trial

Official title:

Comparison of Continuous Epidural and Continuous Paravertebral Blockade in Postoperative Analgesia After Videothoracoscopic Lung Lobectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040662
• Other study ID #: 1/2014
• Status: Completed
• Phase: Phase 2
• First received: January 13, 2014
• Last updated: June 9, 2017
• Start date: January 2013
• Est. completion date: July 2014

Study information

• Verified date: June 2017
• Source: Pulmonary Hospital Zakopane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thoracic surgery correlates with significant pain in postoperative period. In order to alleviate the pain various combinations of pharmaceuticals and administration methods are employed. So as to reduce the extent of surgical trauma and, consequently, correlated pain various operation techniques are used. In traditional thoracotomy epidural anesthesia remains a golden standard. Epidural anesthesia however demands high skills to be performed correctly and presents an increased risk of grave complications. In videothoracoscopic (VATS) operations paravertebral blockade can be employed, yet there is no certainty if its efficacy after lung lobectomy. We therefore designed a prospective, randomized, parallel group, single site study to test the hypothesis, that continuous paravertebral blockade is as efficient in postoperative pain reduction as continuous epidural blockade and possesses a higher safety profile.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status 1-3

2. undergo videothoracoscopic lung lobectomy

3. forced expiratory volume in 1 second (FEV1) >1,5 l/min

4. no contraindications for epidural anesthesia and paravertebral nerve blockade

5. ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.

Exclusion Criteria:

1. prior to the study: contraindications for local anesthesia, ASA>3, FEV1<1,5 l/min, conditions disabling the patient from comprehending the principles of VAS pain examination, known allergy to used medications.

2. during the study: failure to place epidural or paravertebral catheter, decision to abandon lobar resection (e.g. in case of neoplastic dissemination), intraoperative conversion to thoracotomy, intraoperative anatomical obstacles to distribution of local anesthetics, conditions disabling the patient from pain evaluation by means of VAS method (e.g. postoperative delirium), necessity to administer other pharmaceuticals influencing pain perception (e.g. sedatives), necessity of mechanical ventilation, interruption of local anesthesia as a result of technical problems (e.g. damage or slippage of catheter).

Related Conditions & MeSH terms

• Lung Cancer

Intervention

Procedure:
• Continuous Thoracic Epidural Block
Before anesthesia, continuous thoracic epidural block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (air). A catheter is advanced ca. 3-5 cm, and test dose with 2 ml of lidocaine 2% i injected. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 6 ml bolus is injected, followed by an infusion of the same mixture at 0,06 ml/kg/h for postoperative pain management.
• Continuous Thoracic Paravertebral Block
Before anesthesia, continuous thoracic paravertebral block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (normal saline). After injection of 5-10 ml of normal saline a catheter is advanced medially ca. 5 cm. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 20 ml bolus is injected, followed by an infusion of the same mixture at 0,08 ml/kg/h for postoperative pain management
• Patient-Controlled Analgesia with Morphine
Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include: patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min) paracetamol 1000 mg iv every 8 hrs ketoprofen 100 mg iv every 12 hrs

Locations

Country	Name	City	State
Poland	Pulmonary Hospital	Zakopane

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonary Hospital Zakopane

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain intensity measured in VAS in predetermined time intervals after the operation		up to 96 hrs after the surgery
Secondary	respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)		up to 96 hrs after the surgery
Secondary	frequency of side effects of regional anesthesia: urine retention resulting in necessity of bladder catheterization, hypotension, respiratory depression		up to 96 hrs after surgery
Secondary	frequency of respiratory complications: atelectasis or pneumonia		up to 96 hrs after surgery
Secondary	cumulative opioid (morphine) consumption		up to 96 hrs after surgery