Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04209868
Recruitment Status : Recruiting
First Posted : December 24, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Thoracic Neoplasm Chronic Pain Post-Procedural Acute Post-thoracotomy Pain Anesthesia, Local Drug: Levo-Bupivacaine Hydrochloride (HCl) 0.25 % in 20mL Injection Drug: 0.9% Sodium Chloride 20mL Injection Phase 2 Phase 3

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.

Primary Purpose: Treatment
Official Title: Preoperative Paravertebral Block in Cancer Surgery of the Lung: ParaSOL a Prospective Randomized Controlled Clinical Trial
Actual Study Start Date : February 1, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : May 31, 2022

Resource links provided by the National Library of Medicine


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 0.25% Levo-bupivacaine
20ml 0.25% Levo-bupivacaine pre-PVB performed post-induction and pre-incision.
Drug: Levo-Bupivacaine Hydrochloride (HCl) 0.25 % in 20mL Injection
As per arm description




Primary Outcome Measures :
  1. Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3 [ Time Frame: 1 day ]
    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 :
  1. Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing. [ Time Frame: 1 hour ]
    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

  2. Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing. [ Time Frame: 6 hours ]
    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

  3. Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing. [ Time Frame: 24 hours ]
    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

  4. Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing. [ Time Frame: 48 hours ]
    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

  5. Cumulative morphine requirement [ Time Frame: 48 hours ]
    Cumulative morphine requirement over 48 hours post arrival in recovery

  6. Time to first mobilization [ Time Frame: 3 days ]
    Time to first mobilization (walking 50 metres without the aid of another person), measured at baseline pre-operatively and postoperatively on daily assessment.

  7. Incidence of in-hospital complications [ Time Frame: 3 days ]
    Incidence of in-hospital complications (Atrial Fibrillation (AF), Myocardial Infarction (MI), unplanned ICU admission) and respiratory complications, as defined by the Melbourne Group Scale.

  8. Length of hospital stay [ Time Frame: 3 days ]
    Length of hospital stay (in days)

  9. Quality of Life (QoL) score [ Time Frame: Pre-operative and at 3 and 6 months post-operatively ]
    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

  10. Presence of chronic post-surgical pain [ Time Frame: Measured at 3 and 6 months post-operatively ]
    Presence of chronic post-surgical pain (CPSP) (binary yes/no) fulfilling CPSP criteria

  11. Presence of chronic post-surgical pain [ Time Frame: Measured at 3 and 6 months post-operatively ]
    Presence of chronic post-surgical pain assessed by the Brief Pain Inventory Short Form (BPI-SF)

  12. Presence of chronic post-surgical pain [ Time Frame: Measured at 3 and 6 months post-operatively ]
    Presence of chronic post-surgical pain assessed by as defined by the Melbourne Group Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04209868


Contacts
Layout table for location contacts
Contact: Cheng Ong, MBBS +44 2071887188 cheng.ong@gstt.nhs.uk
Contact: Craig R Johnstone, MBChB +44 2071887188 craig.johnstone@gstt.nhs.uk

Locations
Layout table for location information
United Kingdom
Guy's Hospital, Great Maze Pond Recruiting
London, United Kingdom, SE1 9RT
Contact: Gill Arbane    0207 188 8070    gill.arbane@gstt.nhs.uk   
Principal Investigator: Cheng Ong, MBBS         
Sub-Investigator: Craig R Johnstone, MBChB         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Layout table for investigator information
Study Chair: Cheng Ong Guys & St Thmas' NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Guy's and St Thomas' NHS Foundation Trust:
Layout table for additonal information
Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04209868    
Other Study ID Numbers: 244680
First Posted: December 24, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Thoracic Neoplasms
Chronic Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Neoplasms by Site
Neoplasms
Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents