Preoperative Paravertebral Block in Cancer Surgery of the Lung (ParaSOL)
Primary Purpose
Thoracic Neoplasm, Chronic Pain Post-Procedural, Acute Post-thoracotomy Pain
Status
Recruiting
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection
0.9% Sodium Chloride 20mL Injection
Sponsored by
About this trial
This is an interventional treatment trial for Thoracic Neoplasm
Eligibility Criteria
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
Sites / Locations
- Guy's Hospital, Great Maze PondRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Pre-PVB with saline
Pre-PVB with 0.5% Levo-bupivacaine
Arm Description
Placebo (20ml Saline) pre-PVB performed post-induction and pre-incision.
20ml 0.5% Levo-bupivacaine pre-PVB performed post-induction and pre-incision.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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
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
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
Cumulative morphine requirement
Cumulative morphine requirement over 48 hours post arrival in recovery
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.
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.
Length of hospital stay
Length of hospital stay (in 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
Presence of chronic post-surgical pain
Presence of chronic post-surgical pain (CPSP) (binary yes/no) fulfilling CPSP criteria
Presence of chronic post-surgical pain
Presence of chronic post-surgical pain assessed by the Brief Pain Inventory Short Form (BPI-SF)
Presence of chronic post-surgical pain
Presence of chronic post-surgical pain assessed by as defined by the Melbourne Group Scale
Full Information
NCT ID
NCT04209868
First Posted
November 21, 2019
Last Updated
November 15, 2021
Sponsor
Guy's and St Thomas' NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04209868
Brief Title
Preoperative Paravertebral Block in Cancer Surgery of the Lung
Acronym
ParaSOL
Official Title
Preoperative Paravertebral Block in Cancer Surgery of the Lung: ParaSOL a Prospective Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guy's and St Thomas' NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thoracic Neoplasm, Chronic Pain Post-Procedural, Acute Post-thoracotomy Pain, Anesthesia, Local
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
The study will be conducted at Guy's Hospital, London, United Kingdom (UK), a large tertiary thoracic centre for London, Sussex, Kent and Berkshire. In 2015, 459 lung cancer resection operations were performed; 8% of all lung cancer resections in England.
Criteria for discontinuation/withdrawal or modifying allocated treatment:
Participant request to withdraw from the study.
Intraoperative identification of infection/tumour in paravertebral space
Patient recruitment Eligible patients will be identified in the catchment outpatient clinics 4-6 weeks before surgery. The participant information sheet (PIS) will be introduced in the standard surgical booklet given by the surgeon. At the preoperative assessment clinic 2-3 weeks before surgery, a face-to-face discussion with the research nurse will support the PIS; the opportunity to ask any questions and contact a PPI (Patient and Public Involvement) representative and will be given. Written informed consent will be obtained.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Participants will be randomised on the day of surgery to the 'pre-PVB LA' or 'pre-PVB saline' arm, by a study investigator, with a 1:1 randomisation ratio using 'Sealed Envelope' (www.sealedenvelope.com) online software. Each subject will receive a unique randomization code in an envelope that will only be opened during the preparation of the pre-PVB injectate.
A non-blinded research nurse, will prepare the pre-PVB injectate in a standard syringe according to the allocation, labelled by participant number, in a theatre location concealed from the operating room and staff.
The anaesthetist, the surgeon and theatre team, recovery staff, and the researchers performing all the outcome assessments will be separate and blinded to the group allocation. The PVB catheter will be taped as normal before connecting the post-PVB LA infusion pump.
We have elected to perform an interventional placebo intervention as opposed to a sham control to minimize observer bias.
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-PVB with saline
Arm Type
Placebo Comparator
Arm Description
Placebo (20ml Saline) pre-PVB performed post-induction and pre-incision.
Arm Title
Pre-PVB with 0.5% Levo-bupivacaine
Arm Type
Experimental
Arm Description
20ml 0.5% Levo-bupivacaine pre-PVB performed post-induction and pre-incision.
Intervention Type
Drug
Intervention Name(s)
Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection
Intervention Description
As per arm description
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium Chloride 20mL Injection
Intervention Description
As per arm description
Primary Outcome Measure Information:
Title
Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3
Description
The proportion of patients with clinical relevant moderate-to-severe pain (NRS>/=3) related to the surgical site at rest at 24 hours.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Description
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
Time Frame
1 hour
Title
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Description
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
Time Frame
6 hours
Title
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Description
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
Time Frame
24 hours
Title
Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
Description
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
Time Frame
48 hours
Title
Cumulative morphine requirement
Description
Cumulative morphine requirement over 48 hours post arrival in recovery
Time Frame
48 hours
Title
Time to first mobilization
Description
Time to first mobilization (walking 50 metres without the aid of another person), measured at baseline pre-operatively and postoperatively on daily assessment.
Time Frame
3 days
Title
Incidence of in-hospital complications
Description
Incidence of in-hospital complications (Atrial Fibrillation (AF), Myocardial Infarction (MI), unplanned ICU admission) and respiratory complications, as defined by the Melbourne Group Scale.
Time Frame
3 days
Title
Length of hospital stay
Description
Length of hospital stay (in days)
Time Frame
3 days
Title
Quality of Life (QoL) score
Description
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
Time Frame
Pre-operative and at 3 and 6 months post-operatively
Title
Presence of chronic post-surgical pain
Description
Presence of chronic post-surgical pain (CPSP) (binary yes/no) fulfilling CPSP criteria
Time Frame
Measured at 3 and 6 months post-operatively
Title
Presence of chronic post-surgical pain
Description
Presence of chronic post-surgical pain assessed by the Brief Pain Inventory Short Form (BPI-SF)
Time Frame
Measured at 3 and 6 months post-operatively
Title
Presence of chronic post-surgical pain
Description
Presence of chronic post-surgical pain assessed by as defined by the Melbourne Group Scale
Time Frame
Measured at 3 and 6 months post-operatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Ong, MBBS
Phone
+44 2071887188
Email
cheng.ong@gstt.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Craig R Johnstone, MBChB
Phone
+44 2071887188
Email
craig.johnstone@gstt.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Ong
Organizational Affiliation
Guys & St Thmas' NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Guy's Hospital, Great Maze Pond
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gill Arbane
Phone
0207 188 8070
Email
gill.arbane@gstt.nhs.uk
First Name & Middle Initial & Last Name & Degree
Cheng Ong, MBBS
First Name & Middle Initial & Last Name & Degree
Craig R Johnstone, MBChB
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preoperative Paravertebral Block in Cancer Surgery of the Lung
We'll reach out to this number within 24 hrs