Study of Use of Paravertebral Blocks for Pain Relief in Video Assisted Lung Surgery (ErLaPara)
|ClinicalTrials.gov Identifier: NCT01621698|
Recruitment Status : Completed
First Posted : June 18, 2012
Last Update Posted : September 7, 2015
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 or disease||Intervention/treatment||Phase|
|Lung Tumour Lung Metastases||Procedure: Early paravertebral block Procedure: Late Paravertebral block.||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Early Versus Late Paravertebral Block for Analgesia in Video Assisted Thoracoscopic Lung Resection.|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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.
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.
- Pain score on coughing using Visual Analogue Scale (VAS). [ Time Frame: 24 hours. ]Pain scores in first 24 hours to be analysed using area under the curve.
- Morphine consumption [ Time Frame: 24 hours ]Amount of morphine used in first 24 hours via patient controlled analgesia.
- Cortisol levels [ Time Frame: 24 hours ]Cortisol measured at routine blood tests after 24 hours.
- Length of hospital stay [ Time Frame: 3 days (Average) ]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 ]Performed using questionnaires.
- Readmission rates [ Time Frame: 30 days ]
- Survival [ Time Frame: 30 days ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01621698
|United Hospitals Bristol NHS Foundation Trust|
|Bristol, United Kingdom, BS2 8HW|
|Principal Investigator:||Kajan Kamalanathan, BMBS||United Hospitals Bristol NHS Foundation Trust|