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

Completed

• Conditions: Lung Cancer; Postoperative Pain; Thoracoscopic Surgery; Nerve Block; Local Anesthesia; Video Assisted Thoracoscopic Surgery
• Interventions: Drug: Bupivacain; Drug: Dexamethasone

• Registration Number: NCT04633850
• Lead Sponsor: Jannie Bisgaard Stæhr

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-08
• Study First Submitted: 2020-11-03
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-18
• Primary Completion: 2021-04-28
• Study Completion: 2021-04-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Before implementation	Bupivacain	Perineural bupivacaine without adjuvants.
After implementation	Dexamethasone	Perineural bupivacaine with intravenous dexamethasone.

Primary Outcome Measures

Name	Time	Method
Total equipotent dose of opioids	24 hours	Sum of equipotent opioid doses during the first 24 hours after surgery

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Aalborg University Hospital; 🇩🇰 Aalborg, Region Of Northern Jutland, Denmark