Lung Neoplasm, Pain, Postoperative
Conditions
Keywords
Serratus Block, Pain Management, lung lobectomy
Brief summary
A randomized prospective trial to assess whether the use of loco regional anesthesia as adjuvant analgesic therapy is more effective of intravenous analgesia only.
Detailed description
A prospective randomized trial comparing intravenous analgesia alone and in association with loco regional anesthesia consisting in a homolateral Serratus Plan Block (SPB). Loco regional blockade of the serratus is further examined by allocating the patients to two different approaches: the block being performed under US guidance by the Anesthesiologist before the beginning of the procedure, or under direct visualization, by the operating surgeon, before entering the pleural cavity.
Interventions
DRUGRopivacaine for Serratus Plane Block (SPB)
Serratus Plane Block (SPB) injection of low concentration Ropivacaine (30 ml, 0.3%), in the plane between the External Intercostal Muscle and the Serratus Anterior Muscle.
Sponsors
IRCCS Sacro Cuore Don Calabria di Negrar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Given the trial Design, it would be impossible to blind the caregiver about the type of treatment. Serratus Plan Block will be performed after the induction of General Anesthesia, the patients will thus be unaware wether being assigned to the Experimental or Control Arm. Clarification (May 28, 2018): * Nurses assess NRS (Pain Perception) and directly manage rescue doses delivery * Physiotherapists deliver rehab. respiratory exercises and directly assess patient's performance. Since their reports are directly elicited in Clinical Report Forms, they are considered outcome assessors. Both Nurses and Physiotherapists are unaware of treatment allocation.
Intervention model description
Eligible patients will be randomized between two groups: Systemic analgesic therapy only (Endovenous/ Oral) Systemic analgesic therapy plus loco regional therapy administered under Us. guidance before the procedure (Serratus Plane Block). Allocation to one treatment group or another will be randomized with the aim of create two unbiased groups formed out of the same group of patients. Randomization will be provided by a software. Group allocation and treatment is overt to the investigators, but not to the patient.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lobectomy/ Segmentectomy plus lymphadenectomy (systematic or sampling) for cancer (not necessarily NSCLC) performed with a standardized, three portal minimally invasive approach.
Exclusion criteria
* Patients who are pregnant or lactating * Morbid obesity (BMI \> 35 ) * Inability to understand and sign the Informed consent * Proven allergy to local anesthetic drugs as required by this protocol * Patients under chronic analgesics or neuroleptic therapy for any reason and/ or with baseline pain score (NRS scale) of 3 or more.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative pain perception | 24 hours from the end of surgery | Direct request to the patient to define the pain feeling, according to a Numerical Rating Scale (NRS, 0 to 10). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ability to perform post operative rehab exercises | Measured at 24 hrs and 48 hrs after surgery | Number of forced inspiratory maneuvers during rehab respiratory exercises |
| Systemic rescue analgesia consumption (doses) | measured at 6 hrs, 12 hrs, 24 hrs, 36 hrs and 48hrs after surgery | Number of extra doses of pain killers directly required by the patient (Morphine (0.1 mg/kg), Tramadol 100 mg or Ketorolac 30 mg) |
Countries
Italy
Outcome results
None listed