Study of Use of Paravertebral Blocks for Pain Relief in Video Assisted Lung Surgery (ErLaPara)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by United Bristol Healthcare NHS Trust.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
United Bristol Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01621698
First received: June 8, 2012
Last updated: June 15, 2012
Last verified: June 2012
  Purpose

This project involves looking at the timing of providing pain relief for patients who are having lung surgery via the use of a small camera inserted into the chest with a scope (Video assisted thorascopy). This procedure can be the source of intense pain both immediately after the procedure and in the longer term leading to chronic pain problems.

Local anaesthetic placed in the paravertebral space which is located adjacent to the spinal column, where the pain nerve fibres are located, is a well recognized method of providing pain relief for these procedures. It is currently unclear as to the best timings for providing this type of pain relief with some centres placing the local anaesthetic at the start of the procedure and some at the end. Placing a high volume of local anaesthetic into this area at the start of the case may provide better short and long term pain relief than placing it at the end of the procedure. The investigators hope to show a difference between the two timings to allow for better pain relief for these procedures. This would be a feasibility study that would lead onto a multicentre trial to eventually create a best practice protocol for pain relief for lung resection via this surgical method.


Condition Intervention
Lung Tumour
Lung Metastases
Procedure: Early paravertebral block
Procedure: Late Paravertebral block.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Early Versus Late Paravertebral Block for Analgesia in Video Assisted Thoracoscopic Lung Resection.

Resource links provided by NLM:


Further study details as provided by United Bristol Healthcare NHS Trust:

Primary Outcome Measures:
  • Pain score on coughing using Visual Analogue Scale (VAS). [ Time Frame: 24 hours. ] [ Designated as safety issue: No ]
    Pain scores in first 24 hours to be analysed using area under the curve.


Secondary Outcome Measures:
  • Morphine consumption [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Amount of morphine used in first 24 hours via patient controlled analgesia.

  • Cortisol levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Cortisol measured at routine blood tests after 24 hours.

  • Length of hospital stay [ Time Frame: 3 days (Average) ] [ Designated as safety issue: No ]
    Patient's will be followed up for the duration of hospital stay, an expected average of 3 days.

  • Patient satisfaction scores [ Time Frame: 24-48 hours ] [ Designated as safety issue: No ]
    Performed using questionnaires.

  • Readmission rates [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Survival [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early paravertebral block
The early group will have Local anaesthetic placed at the start of surgery and have normal saline placed at the close.
Procedure: Early paravertebral block
In this group the local anaesthetic will be injected at the start of surgery soon after incision and normal saline at the end. These will be double blinded.
Other Names:
  • Bupivicaine
  • Normal Saline
  • Propofol.
  • Fentanyl.
  • Atracurium.
Active Comparator: Late paravertebral block
The late group will have normal saline placed at the start of surgery and local anaesthetic placed at the close.
Procedure: Late Paravertebral block.
In the late group local anaesthetic will be injected at close of surgery with normal saline at the start. This will be double blinded.
Other Names:
  • Bupivicaine
  • Normal Saline
  • Propofol.
  • Fentanyl.
  • Atracurium.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will be recruited from patients admitted for elective VATS for lung resection.
  • Patients aged 18 and over.
  • Patient's will be ASA 1,2 or 3.

Exclusion Criteria:

  • Patient refusal.
  • Emergency surgery.
  • Patient unable to provide consent.
  • Infection in paravertebral space.
  • Patients who attend a chronic pain clinic on high doses of opiate drugs.
  • History of Anaphylaxis/allergy to local anaesthetic.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621698

Contacts
Contact: Kajan Kamalanathan +447843273584 thoracicbris@gmail.com

Locations
United Kingdom
United Hospitals Bristol NHS Foundation Trust Not yet recruiting
Bristol, United Kingdom, BS2 8HW
Principal Investigator: Kajan Kamalanathan         
Sponsors and Collaborators
United Bristol Healthcare NHS Trust
Investigators
Principal Investigator: Kajan Kamalanathan, BMBS United Hospitals Bristol NHS Foundation Trust
  More Information

No publications provided

Responsible Party: United Bristol Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01621698     History of Changes
Other Study ID Numbers: AN/2012/4036
Study First Received: June 8, 2012
Last Updated: June 15, 2012
Health Authority: United Kingdom: National Health Service

Keywords provided by United Bristol Healthcare NHS Trust:
VATS
Paravertebral blocks.
Thoracoscopic surgery.
Analgesia.

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Anesthetics, Local
Bupivacaine
Anesthetics
Fentanyl
Propofol
Atracurium
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Neuromuscular Nondepolarizing Agents
Neuromuscular Blocking Agents
Neuromuscular Agents
Nicotinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014