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

Sponsor
Jannie Bisgaard Stæhr (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05038007
Collaborator
(none)
50
1
2
8.5
5.9

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Liposomal bupivacaine
  • Drug: Bupivacaine Hydrochloride
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Pain After Thoracoscopic Lung Surgery - the Effect of Intercostal Nerve Blockades With Standard Bupivacaine and Liposomal Bupivacaine - a Randomised Controlled Feasibility Trial
Anticipated Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Apr 1, 2022
Anticipated Study Completion Date :
May 31, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Duration of analgesic effect [48 hours]

      Time in hours to first postoperative administration of Pro Re Nata (PRN) opioids

    Secondary Outcome Measures

    1. Total equipotent opioid dose [48 hours]

      Total equipotent opioid dose in milligrams during the first 48 hours after surgery.

    2. Numerical Rating Scale [48 hours]

      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.

    3. Mobilisation [48 hours]

      Time in hours to full mobilisation defined as walking with or without aids.

    4. Opioids at discharge [Not fixed. On average 4 days and a maximum of 3 months.]

      Need for opioids at discharge (yes or no and equipotent dosage)

    5. Patient-reported satisfaction of postoperative pain management assessed by self-made questionnaire in Danish [Measured twice. Once 48 hours after surgery and once at non fixed time(on average 4 days and a maximum of 3 months)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aalborg University Hospital Aalborg Region Of Northern Jutland Denmark 9000

    Sponsors and Collaborators

    • Jannie Bisgaard Stæhr

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jannie Bisgaard Stæhr, Principal Investigator, Aalborg University Hospital
    ClinicalTrials.gov Identifier:
    NCT05038007
    Other Study ID Numbers:
    • AAUH-VATS-01
    First Posted:
    Sep 8, 2021
    Last Update Posted:
    Sep 21, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 21, 2021