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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04633850
• Other study ID #: Smerter efter VATS
• Status: Completed
• Start date: September 8, 2020
• Est. completion date: April 28, 2021

Study information

• Verified date: June 2021
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: April 28, 2021
• Est. primary completion date: April 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Local Anesthesia
• Lung Cancer
• Lung Neoplasms
• Nerve Block
• Postoperative Pain
• Thoracoscopic Surgery
• Video Assisted Thoracoscopic Surgery

Intervention

Drug:
• Dexamethasone
Intravenous dexamethasone 8 mg. Given once at the end of surgery.
• 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.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg	Region Of Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Jannie Bisgaard Stæhr

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total equipotent dose of opioids	Sum of equipotent opioid doses during the first 24 hours after surgery	24 hours
Secondary	Time to first administration of opioids after surgery	In hours and minuts	48 hours
Secondary	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
Secondary	Time for full mobilization	The total time for full mobilization (walk with support)	Through study completion, an average of 1 week
Secondary	Total dose of non-opioid analgesics	Sum of non-opioid doses during the first 24 hours after surgery	24 hours
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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