Pain After Lung Cancer Surgery - Comparing Traditional Versus Prolonged Release Nerve Blockades

Pain After Thoracoscopic Lung Surgery - the Effect of Intercostal Nerve Blockades With Standard Bupivacaine and Liposomal Bupivacaine - a Randomised Controlled Feasibility Trial

To investigate the effect of liposomal bupivacaine compared with bupivacaine hydrochloride for intercostal blockades for patients undergoing Video-assisted thoracoscopic surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain; Anesthesia, Local; Lung Cancer; Video Assisted Thoracoscopic Surgery; Blockades Neuromuscular
• Intervention / Treatment: Drug: Bupivacaine Hydrochloride; Drug: Liposomal bupivacaine

Detailed Description

Video-assisted thoracoscopic surgery (VATS) is a minimally invasive routine procedure. It's less invasive than thoracotomy but postoperative pain is still a problem.

At Aalborg University Hospital, intercostal blockades with bupivacaine is used as standard pain treatment for patients undergoing VATS. Adding adjuvants to the blockades may prolong the effect.

The aim of this study is to examine if intercostal nerve blockades with liposomal bupivacaine improves postoperative pain management compared to intercostal nerve blockades with bupivacaine hydrochloride.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jannie Bisgaard, MD, PhD; Phone Number: 0045 97660578; Email: j.staehr@rn.dk
• Study Contact Backup: Name: Phillip Sperling, BSc; Phone Number: 0045 21141411; Email: phis@rn.dk

Study Locations

• Denmark
  • Region Of Northern Jutland
    • Aalborg, Region Of Northern Jutland, Denmark, 9000
      • Aalborg University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults independent of sex with an age of ≥ 18 years
• Patients undergoing VATS as a part of either examination or treatment of lung cancer

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Bupivacaine Hydrochloride in perioperative intercostal blockades	Drug: Bupivacaine Hydrochloride; As prior described; Other Names: Marcaine
Experimental: Intervention; Liposomal bupivacaine in perioperative intercostal blockades	Drug: Liposomal bupivacaine; As prior described; Other Names: Exparel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of analgesic effect	Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total equipotent opioid dose	Total equipotent opioid dose in milligrams during the first 48 hours after surgery.	48 hours
Numerical Rating Scale	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.	48 hours
Mobilisation	Time in hours to full mobilisation defined as walking with or without aids.	48 hours
Opioids at discharge	Need for opioids at discharge (yes or no and equipotent dosage)	Not fixed. On average 4 days and a maximum of 3 months.
Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish	Patients are asked to fill out a questionnaire rating their general satisfaction with pain management and sufficiency of pain treatment on a scale from 0 to 10. The questionnaire also assess whether the patients had any perceived side effects and how uncomfortable they were on a scale from 0 to 10.	Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months)

Collaborators and Investigators

• Sponsor: Jannie Bisgaard Stæhr
• Investigators: Principal Investigator: Jannie Bisgaard, MD, PhD, Aalborg University Hospital, department of Anaesthesiology

Study record dates

Study Major Dates

• Study Start (Anticipated): September 15, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): May 31, 2022

Study Registration Dates

• First Submitted: August 25, 2021
• First Submitted That Met QC Criteria: August 31, 2021
• First Posted (Actual): September 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: AAUH-VATS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No