Clinical trial NCT04209868: Preoperative Paravertebral Block in Cancer Surgery of the Lung
Official title: Preoperative Paravertebral Block in Cancer Surgery of the Lung: ParaSOL a Prospective Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Thoracic Neoplasm
Chronic Pain Post-Procedural
Acute Post-thoracotomy Pain
Anesthesia, Local
Lead sponsor: Guy's and St Thomas' NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Moderate-to-severe pain Numerical Rating Scale (NRS) >/=3
timeFrame: 1 day
Secondary outcomes:
measure: Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
timeFrame: 1 hour
measure: Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
timeFrame: 6 hours
measure: Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
timeFrame: 24 hours
measure: Acute postoperative pain related to the surgical site as measured by a numerical rating scale (NRS) at rest and on coughing.
timeFrame: 48 hours
measure: Cumulative morphine requirement
timeFrame: 48 hours
measure: Time to first mobilization
timeFrame: 3 days
measure: Incidence of in-hospital complications
timeFrame: 3 days
measure: Length of hospital stay
timeFrame: 3 days
measure: Quality of Life (QoL) score
timeFrame: Pre-operative and at 3 and 6 months post-operatively
measure: Presence of chronic post-surgical pain
timeFrame: Measured at 3 and 6 months post-operatively
measure: Presence of chronic post-surgical pain
timeFrame: Measured at 3 and 6 months post-operatively
measure: Presence of chronic post-surgical pain
timeFrame: Measured at 3 and 6 months post-operatively
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's Hospital, Great Maze Pond
Study officials:
affiliation: Guys & St Thmas' NHS Foundation Trust
name: Cheng Ong
role: STUDY_CHAIR
References: