Preoperative Paravertebral Block in Cancer Surgery of the Lung

Anesthesia, Local Clinical Trial

— ParaSOL  

Official title:

Preoperative Paravertebral Block in Cancer Surgery of the Lung: ParaSOL a Prospective Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04209868
• Other study ID #: 244680
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: February 1, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Guy's and St Thomas' NHS Foundation Trust
• Contact: Cheng Ong, MBBS
• Phone: +44 2071887188
• Email: cheng.ong[@]gstt.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim to determine whether ultrasound-guided preemptive paravertebral blockade (PVB) local anaesthetic (pre-PVB LA), administered in addition to the post-operative PVB (post-PVB) local anaesthetic (LA) infusion, reduces acute postoperative pain, opioid requirement, chronic pain, and improves surgical recovery, in thoracoscopic surgery for lung cancer.

Description:

In the UK, there has been an increase in lung cancer operations, especially in high risk and elderly patients, improving survival from 10.6% in 2008 to 15.1% in 2013. Lung cancer surgery is associated with severe acute pain, a high incidence of respiratory complications and chronic post-surgical pain. Severe acute postoperative pain is a strong predictor of CPSP. The improvement of perioperative outcomes in elderly patients, the benefits of regional anaesthesia and reduction of chronic pain are investigative priorities of the Anaesthesia and Perioperative Care Setting Partnership.

Enhanced recovery strategies include video-assisted thoracoscopic surgery (VATS), a minimally invasive alternative to open thoracotomy, which may be associated with less postoperative pain. Regional anaesthesia, by thoracic epidural analgesia (TEA) or PVB, is superior to systemic opioids in reducing acute pain after thoracotomy surgery.

Preemptive analgesia describes the aim of minimizing central spinal pain transmission by noxious stimuli arising from events at surgery, by administering an analgesic technique prior to surgical incision. Regional blockade affects central sensitization, allowing analgesia to outlast the pharmacological sensory blockade.

Compared to TEA initiated after surgery, acute pain severity is reduced by preemptive TEA. There are conflicting reports on the benefit of preemptive analgesia in other types of surgery, but TEA and PVB may prevent CPSP in thoracotomy and breast surgery. Some small studies have shown that pre-PVB reduces acute postoperative pain.

Paravertebral blockade is known to be as effective as TEA for acute postoperative analgesia following thoracic surgery, whilst having a lower incidence of pulmonary complications, hypotension and nausea. It is conventional practice in many centres for the surgical administration and placement of a catheter at the end of surgery for postoperative LA infusion (post-PVB) as the sole method of regional analgesia. Preoperative PVB is less common: anaesthetists may use a landmark technique, single or multiple injections and different volumes/strengths of LA.

Ultrasound guidance for pre-PVB injection increases accuracy. In an audit using this technique with post-PVB compared to post-PVB only, the investigators demonstrated reduced pain numerical rating scale (NRS) scores in elective VATS patients, (mean NRS at 24h 2.5 vs 4.5), and a reduction in the proportion of patients who experienced moderate-to-severe pain of NRS≥ 3 from 83% to 50% at 24h.

The investigators therefore aim to evaluate the contribution of ultrasound-guided pre-PVB, administered in addition to the post-PVB LA infusion, in reducing the severity of acute postoperative pain, perioperative opioid requirement, development of CPSP, and improving patient outcome in lung cancer patients undergoing VATS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective radical primary lung cancer VATS surgery for single lobectomy

• American Society of Anesthesiology (ASA) I-III

• Age =18

Exclusion Criteria:

• Planned open thoracotomy, wedge resection, bilobectomy, pneumonectomy, chest wall resection or total pleurectomy

• Local anaesthetic or opioid allergy

• Coagulation disorders

• Inability to comply with study questionnaire completion

• Pre-existing pain in chest area or pre-existing pain conditions

• Local infection/tumour at proposed PVB site

• Previous lung surgery

• Planned surgery within 3 months of the primary lung resection

Related Conditions & MeSH terms

• Acute Post-thoracotomy Pain
• Anesthesia, Local
• Chronic Pain
• Chronic Pain Post-Procedural
• Thoracic Neoplasm
• Thoracic Neoplasms

Intervention

Drug:
• Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection
As per arm description
• 0.9% Sodium Chloride 20mL Injection
As per arm description

Locations

Country	Name	City	State
United Kingdom	Guy's Hospital, Great Maze Pond	London

Sponsors (1)

Lead Sponsor	Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3	The proportion of patients with clinical relevant moderate-to-severe pain (NRS>/=3) related to the surgical site at rest at 24 hours.	1 day
Secondary	Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.	Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing, preoperatively, and after arrival in recovery at 1, 6, 24 and 48 hours	1 hour
Secondary	Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.	Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing, preoperatively, and after arrival in recovery at 1, 6, 24 and 48 hours	6 hours
Secondary	Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.	Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing, preoperatively, and after arrival in recovery at 1, 6, 24 and 48 hours	24 hours
Secondary	Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.	Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing, preoperatively, and after arrival in recovery at 1, 6, 24 and 48 hours	48 hours
Secondary	Cumulative morphine requirement	Cumulative morphine requirement over 48 hours post arrival in recovery	48 hours
Secondary	Time to first mobilization	Time to first mobilization (walking 50 metres without the aid of another person), measured at baseline pre-operatively and postoperatively on daily assessment.	3 days
Secondary	Incidence of in-hospital complications	Incidence of in-hospital complications (Atrial Fibrillation (AF), Myocardial Infarction (MI), unplanned ICU admission) and respiratory complications, as defined by the Melbourne Group Scale.	3 days
Secondary	Length of hospital stay	Length of hospital stay (in days)	3 days
Secondary	Quality of Life (QoL) score	Quality of Life (QoL) score as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) version 3	Pre-operative and at 3 and 6 months post-operatively
Secondary	Presence of chronic post-surgical pain	Presence of chronic post-surgical pain (CPSP) (binary yes/no) fulfilling CPSP criteria	Measured at 3 and 6 months post-operatively
Secondary	Presence of chronic post-surgical pain	Presence of chronic post-surgical pain assessed by the Brief Pain Inventory Short Form (BPI-SF)	Measured at 3 and 6 months post-operatively
Secondary	Presence of chronic post-surgical pain	Presence of chronic post-surgical pain assessed by as defined by the Melbourne Group Scale	Measured at 3 and 6 months post-operatively