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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04633850
Enrollment
45
Registered
2020-11-18
Start date
2020-09-08
Completion date
2021-04-28
Last updated
2021-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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).

Interventions

DRUGDexamethasone

Intravenous dexamethasone 8 mg. Given once at the end of surgery.

DRUGBupivacain

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.

Sponsors

Jannie Bisgaard Stæhr
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total equipotent dose of opioids24 hoursSum of equipotent opioid doses during the first 24 hours after surgery

Secondary

MeasureTime frameDescription
Numerical rating scale score24 hoursPain score reported by the patient after surgery from 0 (no pain) to 10 (worst imaginable pain) in whole numbers.
Time for full mobilizationThrough study completion, an average of 1 weekThe total time for full mobilization (walk with support)
Total dose of non-opioid analgesics24 hoursSum of non-opioid doses during the first 24 hours after surgery
The need for pain medication at dischargeAt discharge from hospital, an average of 1 weekThe need for pain medication at discharge (all forms, type, dose)
Postoperative complication (Empyema)At discharge from hospital, an average of 1 weekEmpyema (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)
Time to first administration of opioids after surgery48 hoursIn hours and minuts
Postoperative complication (Reoperation)At discharge from hospital, an average of 1 weekReoperation (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 weekPneumonia (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 weekPleural 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 weekThe 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)
Postoperative complication (Air leakage)At discharge from hospital, an average of 1 weekAir leakage (yes/no) as complication to the surgery described in the patients journal at discharge (epicrisis)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026