Post Operative Pain, Thoracic Cancer
Conditions
Keywords
postoperative pain, regional anesthesia, thoracoscopy
Brief summary
The goal of this study is to compare the efficacy in controlling postoperative pain of paravertebral block (PVB) with methylene blue visual confirmation and thoracic epidural anesthesia (TEA). This is a single center, parallel-group, prospective study. Patients will be randomly assigned in a 1:1 ratio to receive either PVB or TEA. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale. The secondary end-points are time to perform TEA and PVB, total opioid consumption, postoperative outcomes.
Detailed description
The management of postoperative pain in patients undergoing thoracoscopic lobectomy is a fundamental part of the process of recovery. Uncontrolled thoracic pain in the early postoperative period may interfere with the mobilization of the patients, leading to increased morbidity and reduction in the quality of life. Thoracic paravertebral block (PVB) is an effective strategy for controlling postoperative pain after video-assisted thoracoscopic (VATS) lobectomy, but it may be subjected to a high rate of failure due to incorrect identification of the site of local anesthetic injection. Thoracic epidural anesthesia (TEA) is considered a reliable technique for regional thoracic anesthesia, however potential side effects may limit its use. Herein the investigators reported a new technique using methylene blue as a visual confirmation of the correct anesthetic diffusion during PVB. Then, the investigators will compare the efficacy of methylene blue PVB with TEA for the management of postoperative pain in patients undergoing VATS lobectomy. This is a single center, parallel-group, prospective study. Participants will be randomly assigned in a 1:1 ratio to receive either PVB with methylene blue or TEA. All participants will receive postoperatively intravenous acetaminophen as additional analgesics and intravenous tramadol as rescue analgesic. Primary end-point is pain relief measured with Postoperative Numeric Rating Scale at at 1, 12, 24, 48 hours postoperatively. The secondary end-points are: (i) time to perform TEA and PVB, (ii) total opioid consumption, (iii) postoperative outcomes (including complications, chest drainage duration and length of hospital stay).
Interventions
PROCEDUREParavertebral block with methylene blue
The paravertebral space is identified under ultrasound guidance and after negative aspiration a 3 ml test dose of anesthetic is injected. After observing widening of the paravertebral space and anterior pleural displacement to confirm the correct needle positioning, a bolus dose of 20 mL 0.5% ropivacaine with a solution of 1 ml 1% methylene blue and 4 ml of saline will be injected in the paravertebral space. At the start of the surgery, the spread of the solution of anesthetic and methylene blue will be assessed through visualization in thoracoscopy and if necessary the block will be repeated. After the surgery, intravenous acetaminophen will be administered 3 times daily and tramadol 50 mg will be prescribed as rescue analgesic.
PROCEDUREThoracic Epidural Anesthesia
The epidural catheter will be placed using the loss of resistance technique, and after ruling out intravenous or intrathecal catheter placement with a negative aspiration test dose, an initial dose of 10 mL 0.25% bupivacaine will be injected. Continuous infusion will be started with with 0.125 % bupivacaine + fentanyl 0.5 mcg/ ml at 6-10 ml/hour will be started based on the patient weight for 48 hours postoperatively. After the surgery, intravenous acetaminophen will be administered 3 times daily and tramadol 50 mg will be prescribed as rescue analgesic.
Sponsors
University of Campania Luigi Vanvitelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Males and females aged 18 - 85 years old * scheduled to undergo thoracoscopic lobectomy for lung cancer * standardized three-port anterior thoracoscopic approach
Exclusion criteria
* Allergy to any of the drugs used in the study * Previous thoracic surgical procedures or lung resection * Psychiatric disorders * ASA (American Society of Anesthesiologists) Class \> III * Conversion to thoracotomy * Lack of written informed consent * Participation to other studies * Contraindications to epidural analgesia or paravertebral block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Pain Scores on the Postoperative Numeric Rating Scale in the first 48 hours postoperatively | 1 hours, 12 hours, 24 hours and 48 hours after surgery | Pain scores at rest and after cough will be evaluated in the first 48 hours postoperatively using Postoperative Numeric Rating Scale (NRS) ranging from 0 (absence of pain) to 10 (maximum level of pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | From hospital admission to discharge, up to 20 days | Total days of hospital stay will be recorded |
| Opioids consumption | through the entire hospital stay, an average of 8 days | Cumulative dose of intravenous opioids administered as rescue analgesic will be registered during the post-operative period. |
| Time to perform PVB or TEA | From the identification of the site of injection to the start of general anesthesia, up to 1 hour | Time needed to perform PVB or TEA will be recorded |
| Chest tube duration | From chest tube placement to chest tube removal, up to 20 days | Total days of chest tube duration will be recorded |
Countries
Italy
Outcome results
None listed