Patient-Controlled Thoracic Paravertebral Block After Video-Assisted Thoracoscopic Surgery

Summary

Thoracic surgery is commonly associated with severe postoperative pain and marked impairment of respiratory function.1 Minimally invasive video-assisted thoracic surgery (VATS) is assumed to result in better quality of life and less postoperative pain compared with standard open thoracotomy, other investigators have reported comparable patient-reported physical component summary and pain scores after VATS and thoracotomy during the first 12 months after lung resection.2 That study was non-randomized and 41% of the included patients did not complete the follow-up period.2 VATS has recently been increasing in popularity as a fast-track surgery with potential enhanced recovery after surgery.

Variety of approaches exist to manage pain after thoracotomy which could attenuate post-thoracotomy pulmonary dysfunction. Epidural analgesia has been considered for many decades to be the best method of pain relief after major thoracic surgery. In previous meta-analyses,3-5 many investigators have reported that thoracic paravertebral blockade (PVB) has comparable analgesic effects to thoracic epidural analgesia (TEA) in patients undergoing thoracotomy.

Additionally, PVB has a better side-effect profile, lower rates of failed block and is associated with a reduction in pulmonary complications.3-5 This could be extended to VATS to enhance recovery after surgery owing to effective analgesia and fewer side effects.6-7

Patient-controlled analgesia (PCA) has been advocated as a favourable model for postoperative analgesia, that allows a perfect match between intensity of pain and analgesic delivery, improves the quality of analgesia and decreases the cumulative analgesic consumption. Furthermore, the introduction of patient-controlled epidural analgesia (PCEA) with background infusion during labour gave patients a sense of control over their analgesia, reduced the total dose of local anesthetic administered, and had less motor block than those who receive continuous epidural analgesia.8-9Patient-controlled epidural analgesia (PCEA) has become increasingly popular for pain control after thoracotomy.10-12 In a previous preliminary study, McElwain et al.13 have reported satisfactory analgesia after breast cancer surgery with the use of PC-PVB, using either 15-min or 30-min lockout, that study did not include a comparative arm with a continuous paravertebral infusion. Furthermore, Abou Zeid et al. have reported comparable analgesia after thoracic surgery with the use of either patient-controlled PVB had with the use of intrathecal morphine, that study was not controlled and included few patients.14

The efficacy of the patient-controlled paravertebral blockade (PC-PVB) on the quality of postoperative analgesia and pulmonary function after VATS has not yet been studied.

Conditions

• Video-assisted Thoracoscopic Surgery

Interventions

PROCEDURE

Continuous paravertebral analgesia (C-PVB)

Patients will receive continuous paravertebral infusion of bupivacaine 0.2% and fentanyl 2 μg mL-1 at rate of 8 mL h-1

PROCEDURE

Patient-controlled paravertebral analgesia (PC-PVB)

Patients will receive background continuous paravertebral infusion of bupivacaine 0.2% and fentanyl 2 μg mL-1 at rate of 8 mL h-1 with patient demand bolus dose of 3 mL and lockout time of 15 min with a 20 mL h-1 maximum dose, irrespective of their age

Sponsors & Collaborators

• Imam Abdulrahman Bin Faisal University

  lead OTHER

Principal Investigators

• Yasser Al Jehani, MD · Chairman of Surgery Dept

• Mohamed R El Tahan, MD · Imam Abdulrahman Bin Faisal University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-01-31

Primary Completion

2020-02-29

Completion

2020-06-30

Countries

• Saudi Arabia

Study Locations