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NCT Number: NCT02040662

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pulmonary Hospital

Zakopane, 34-500, Poland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • American Society of Anesthesiologists (ASA) physical status 1-3
  • undergo videothoracoscopic lung lobectomy
  • forced expiratory volume in 1 second (FEV1) >1,5 l/min
  • no contraindications for epidural anesthesia and paravertebral nerve blockade
  • ability to comprehend principles of VAS pain examination method and to communicate in accordance with them.

Exclusion criteria

  • 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.
  • 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).

Treatment and study plan

Continuous Thoracic Epidural Block

Procedure

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

Procedure

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

Procedure

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

Primary outcomes

  1. pain intensity measured in VAS in predetermined time intervals after the operation

    Time frame: up to 96 hrs after the surgery

Secondary outcomes

  1. respiratory parameters indirectly indicating conditions for efficient cough: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC)

    Time frame: up to 96 hrs after the surgery

  2. frequency of side effects of regional anesthesia: urine retention resulting in necessity of bladder catheterization, hypotension, respiratory depression

    Time frame: up to 96 hrs after surgery

  3. frequency of respiratory complications: atelectasis or pneumonia

    Time frame: up to 96 hrs after surgery

  4. cumulative opioid (morphine) consumption

    Time frame: up to 96 hrs after surgery

Sponsors and collaborators

Lead sponsor

Pulmonary Hospital Zakopane

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2014
Registry last updated
Jun 12, 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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