Preoperative Paravertebral Block in Cancer Surgery of the Lung

NCT04209868 | Recruiting Phase 2

• 1 other identifier: 244680
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.

  1 hour

• Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.

  6 hours

• Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.

  24 hours

• Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.

  48 hours

• Cumulative morphine requirement

  48 hours

Study Arms (2)

Pre-PVB with saline

PLACEBO COMPARATOR

Placebo (20ml Saline) pre-PVB performed post-induction and pre-incision.

Drug: 0.9% Sodium Chloride 20mL Injection

Pre-PVB with 0.5% Levo-bupivacaine

EXPERIMENTAL

20ml 0.5% Levo-bupivacaine pre-PVB performed post-induction and pre-incision.

Drug: Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection

Interventions

Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection DRUG

As per arm description

Pre-PVB with 0.5% Levo-bupivacaine

0.9% Sodium Chloride 20mL Injection DRUG

As per arm description

Pre-PVB with saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective radical primary lung cancer VATS surgery for single lobectomy
• American Society of Anesthesiology (ASA) I-III
• Age ≥18

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's Hospital, Great Maze Pond

London, SE1 9RT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Thoracic Neoplasms

Interventions

Injections; Sodium Chloride

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Cheng Ong

  Guys & St Thmas' NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Cheng Ong, MBBS

CONTACT

+44 2071887188; cheng.ong@gstt.nhs.uk

Craig R Johnstone, MBChB

CONTACT

+44 2071887188; craig.johnstone@gstt.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 21, 2019
• First Posted: December 24, 2019
• Study Start: February 1, 2019
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)