Preoperative Paravertebral Block in Cancer Surgery of the Lung (ParaSOL)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia, Local; Thoracic Neoplasm; Acute Post-thoracotomy Pain; Chronic Pain Post-Procedural
• Intervention / Treatment: Drug: 0.9% Sodium Chloride 20mL Injection; Drug: Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Cheng Ong, MBBS; Phone Number: +44 2071887188; Email: cheng.ong@gstt.nhs.uk
• Study Contact Backup: Name: Craig R Johnstone, MBChB; Phone Number: +44 2071887188; Email: craig.johnstone@gstt.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 9RT
    • Recruiting
    • Guy's Hospital, Great Maze Pond
    • Contact: Gill Arbane; Phone Number: 0207 188 8070; Email: gill.arbane@gstt.nhs.uk
    • Principal Investigator: Cheng Ong, MBBS
    • Sub-Investigator: Craig R Johnstone, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Pre-PVB with saline; Placebo (20ml Saline) pre-PVB performed post-induction and pre-incision.	Drug: 0.9% Sodium Chloride 20mL Injection; As per arm description
Experimental: Pre-PVB with 0.5% Levo-bupivacaine; 20ml 0.5% Levo-bupivacaine pre-PVB performed post-induction and pre-incision.	Drug: Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection; As per arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Cumulative morphine requirement	Cumulative morphine requirement over 48 hours post arrival in recovery	48 hours
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
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
Length of hospital stay	Length of hospital stay (in days)	3 days
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
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
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
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

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Study Chair: Cheng Ong, Guys & St Thmas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 28, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Pain; Neurologic Manifestations; Chronic Pain; Thoracic Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine; Levobupivacaine
• Other Study ID Numbers: 244680

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No