Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients

Implementation of Adjuvants in Intercostal Nerve Blockades for Thoracoscopic Surgery in Pulmonary Cancer Patients: A Before and After Study

To investigate the effect of intercostal blockade with and without adjuvants.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Lung Cancer; Local Anesthesia; Thoracoscopic Surgery; Nerve Block; Video Assisted Thoracoscopic Surgery
• Intervention / Treatment: Drug: Bupivacain; Drug: Dexamethasone

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 investigate if intercostal nerve blockade with adjuvants (intravenous (IV) dexamethasone) will result in better pain management.

The primary plan was to evaluate the effect of adding IV dexamethasone and perineural adrenaline, but due to adverse effects, adrenaline was first reduced and later removed from the intervention (amendment protocol N-20200040 approved by the Ethics Committee of Northern Jutland on February 2nd 2021).

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

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

• Sampling Method: Non-Probability Sample

Study Population

Adult lung cancer patients scheduled to undergo VATS at Aalborg University Hospital.

Description

Inclusion Criteria:

° Consecutive adult patients over 18 years of age scheduled to undergo VATS because of verified/suspected lung cancer.

Exclusion Criteria:

• Inability to understand verbal and written information.
• Preexisting chronic pain condition.
• Preoperative daily treatment with pain medication (Non-opioids, opioids, gabapentin/pregabalin).
• Previous thoracic surgery.
• Previous chemotherapy due to thoracic malignancy and / or radiation therapy. to the thorax.
• Pregnant women.
• Autoimmune neuromuscular diseases (sclerosis, peripheral neuromuscular disorders). General muscle weakness or atrophy.
• Hypersensitivity, allergy or intolerance to dexamethasone, bupivacaine or adrenaline.
• Preoperative epidural anaesthesia.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before implementation; Perineural bupivacaine without adjuvants.	Drug: Bupivacain; Bupivacaine dose according to weight. <60 kg: Total dose 100mg 60-90kg: Total dose 150mg >90kg: Total dose 200mg Given once at the end of surgery.
After implementation; Perineural bupivacaine with intravenous dexamethasone.	Drug: Dexamethasone; Intravenous dexamethasone 8 mg. Given once at the end of surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total equipotent dose of opioids	Sum of equipotent opioid doses during the first 24 hours after surgery	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first administration of opioids after surgery	In hours and minuts	48 hours
Numerical rating scale score	Pain score reported by the patient after surgery from 0 (no pain) to 10 (worst imaginable pain) in whole numbers.	24 hours
Time for full mobilization	The total time for full mobilization (walk with support)	Through study completion, an average of 1 week
Total dose of non-opioid analgesics	Sum of non-opioid doses during the first 24 hours after surgery	24 hours
The need for pain medication at discharge	The need for pain medication at discharge (all forms, type, dose)	At discharge from hospital, an average of 1 week
Postoperative complication (Empyema)	Empyema (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)	At discharge from hospital, an average of 1 week
Postoperative complication (Air leakage)	Air leakage (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)	At discharge from hospital, an average of 1 week
Postoperative complication (Reoperation)	Reoperation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)	At discharge from hospital, an average of 1 week
Postoperative complication (Pneumonia)	Pneumonia (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)	At discharge from hospital, an average of 1 week
Postoperative complication (Drainage of pleural effusion)	Pleural effusion (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)	At discharge from hospital, an average of 1 week
Postoperative complication (Oyxgen therapy)	The need for supplemental oxygen therapy and need for mechanical ventilation (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)	At discharge from hospital, an average of 1 week

Collaborators and Investigators

• Sponsor: Jannie Bisgaard Stæhr
• Investigators: Principal Investigator: Jannie Bisgaard Stæhr, PhD, MD, Department of anaesthesia

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 8, 2020
• Primary Completion (ACTUAL): April 28, 2021
• Study Completion (ACTUAL): April 28, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (ACTUAL): November 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): July 1, 2021
• Last Update Submitted That Met QC Criteria: June 28, 2021
• Last Verified: June 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; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: Smerter efter VATS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No