Pain after lung cancer surgery – comparing traditional versus prolonged release nerve blockades

Phase 1

Active, not recruiting

Conditions: Acute postoperative painLung cancer
MedDRA version: 20.0Level: LLTClassification code 10025044Term: Lung cancerSystem Organ Class: 100000004864
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2021-003218-38-DK

Lead Sponsor: Aalborg University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 50

Inclusion Criteria

Adults independent of sex with an age of = 18 years
Patients undergoing VATS as a part of either examination or radical treatment of lung cancer
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

Patients who are unable to understand oral and written information.

Patients with known chronic pain in the thorax which have been persisting for at least six months before the day of surgery.

Pregnant and nursing women.

Patients with hypersensitivity / allergy / Intolerance to dexamethasone or bupivacaine.

Patients receiving a planned preoperative epidural blockade during their stay.

Patients converted to open surgery

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine HCL. ;Secondary Objective: Not applicable.;Primary end point(s): Time to first postoperative administration of Pro Re Nata (PRN) opioids. ;Timepoint(s) of evaluation of this end point: Hours

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1. Total equipotent opioid dose in milligrams during the first 48 hours after surgery. <br>2. Pain intensity on a Numerical Rating Scale ranging from 0 indicating no pain to 10 indicating worst pain imaginable during the first two postoperative days. <br>3. Time to full mobilisation defined as walking with or without aids. <br>4. Need for opioids (yes or no and equipotent dosage) <br>5. Patient-reported satisfaction of postoperative pain management;Timepoint(s) of evaluation of this end point: 1. 48 hours after surgery<br>2. The evening following surgery, then 2 times daily the first 48 hours.<br>3. Hours<br>4. At discharge<br>5. At discharge or at 48 hours after surgery if still admitted