ParaSOL: a prospective randomized controlled clinical trial
Research type
Research Study
Full title
Preoperative paravertebral block in cancer surgery of the lung: ParaSOL - a prospective randomized controlled clinical trial
IRAS ID
244767
Contact name
Cheng Ong
Contact email
Sponsor organisation
Guys & St Thomas NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Lung cancer surgery is increasingly performed in those with poor health and advanced age. It is associated with severe pain, and a high risk of chest problems after surgery. Ideal pain control should allow coughing and walking to prevent chest complications. Paravertebral local anaesthetic blockade (PVB) for lung surgery may be effective for postoperative pain control, with a low risk of side effects. Local anaesthetic ‘numbing’ medicine is placed in the lining of the lung, numbing the nerves which transmit pain from the surgical wound. Preliminary audit suggests that a PVB, aided by an ultrasound scanner, before the operation starts may reduce pain after ‘keyhole’ surgery. We would like to conduct a randomised controlled trial comparing this method of PVB, in addition to the usual PVB local anaesthetic infusion after surgery versus only being given PVB local anaesthetic after surgery, in reducing postoperative pain and the use of strong painkillers, aiding recovery.
Trial patients will be asleep under anaesthetic as normal for lung surgery. Patients will then receive a PVB injection; only those in the intervention group will given local anaesthetic through this injection, whilst the non-intervention group will be given only saline (placebo). Potential participants will receive a patient information sheet, and undergo written, informed consent, and be able to discuss the study with a research team member. Patients will be allocated at random to either the intervention or non-intervention group. Patients will be questioned using short questionnaires preoperatively and at 1, 6, 24, 48h, and 3 and 6 months following surgery. The outcomes measured are the reduction of postoperative pain, the amount of morphine pain medicines after surgery, patient recovery and quality of life measurements.
Better experience of recovery would make lung surgery accessible to patients with poorer health, allowing more patients to be offered curative surgery.
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1334
Date of REC Opinion
12 Nov 2019
REC opinion
Further Information Favourable Opinion