Effects and Dose Response of Dexamethasone on Intercostal Blocks With Bupivicaine in Post Thoracic Surgery Patients

NCT02936427 | Unknown Phase 3

• 1 other identifier: PIL/Consentvs1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Post-op analgesia is the most important part of early and safe patient recovery in thoracic surgery. This is for both humane and patient outcome reasons. Patient outcomes are greatly improved with optimal pain control and complications and length of stay are minimized. Most post-op thoracic complications are from decreased respiratory effort, failure to clear secretions and pulmonary infections from retained sputum with subsequent sequelae. Good post-operative analgesia not only prevents these complications but also considerably enhances early mobilization and thus, decreased hospital stay and efficient resource allocation. Early post-operative pain is also associated with late and chronic post thoracotomy pain syndromes which can be debilitating. Pain following thoracic surgery is different to the standard surgical incision pain and is due to intercostal nerve damage, compression or traction injury to the nerve. This occurs with the incision, rib retraction, and is compounded by the on-going need for respiratory effort. The approach to managing this pain is multi-modal analgesia. The standard regimen stretches from preemptive analgesia and preoperative placement of thoracic epidurals to post-op opioid infusions. However, non-invasive pharmacology includes paracetamol, non steroidal anti inflammatory drugs (NSAIDs), mild and moderate opioids as well as anti-convulsants like pregabalin. However, opioid use has well-known side effects including central nervous system (CNS) and respiratory depression which unfortunately delay mobility and recovery. This has motivated opioid-sparing strategies. The investigators study aims to assess whether the addition of perineural dexamethasone (a steroid) to the current practice of local anaesthetic wound catheters increases the efficacy and duration of analgesia provided.

Conditions

Pain

Outcome Measures

Primary Outcomes (3)

• Amount of analgesia used in 24hrs

  Cumulative analgesia used over 24hrs

  0- 24hrs from surgery

• Amount of analgesia used in 48hrs

  Cumulative analgesia used in 48 hrs

  0-48hrs from surgery

• Amount of analgesia used in 1 month from date of surgery

  Cumulative analgesia used over 1 month

  0hrs - 1 month from surgery

Secondary Outcomes (3)

• Pain reported by patient at 24hrs

  recording of patients level of pain 24hrs post op

• Pain reported by patient at 48hrs

  recording of patients level of pain 48hrs post op

• Pain reported by patient 1 month post op

  recording of patients level of pain 1 month post op

Study Arms (3)

Control

NO INTERVENTION

Control group will receive normal post operative care including intercostal wound catheters however will not receive dexamethasone

Dexamethasone 4mg

EXPERIMENTAL

Participants will receive 4mg of dexamethasone into the intercostal space surrounding the intercostal nerve prior to the first incision. They will then receive routine post operative care including intercostal wound catheters.

Drug: Dexamethasone

Dexamethasone 8mg

EXPERIMENTAL

Participants will receive 8mg of dexamethasone into the intercostal space surrounding the intercostal nerve prior to the first incision. They will then receive routine post operative care including intercostal wound catheters.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

perineural infiltration of dexamethasone

Also known as: Dexamethasone phosphate

Dexamethasone 4mg; Dexamethasone 8mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18
• Consenting
• undergoing VATS procedure

You may not qualify if:

• Age \<18
• Refusal to consent
• Equipment failure
• Allergic reactions to local anaesthetic agent
• Incipient agents or opioid
• Patients on pre-existing long-term opioid use
• Any other concomitant or surgery within 2 weeks of the thoracic surgery

Sponsors & Collaborators

• University College Dublin: lead

Study Sites (1)

St Vincent's University Hospital

Dublin, Leinster, Dublin 4, Ireland

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Dexamethasone; dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Mark C Murphy, MB BcH BAO

  Surgical SHO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark C Murphy, Mb Bch BAO

CONTACT

00353877680018; markmurphy1608@gmail.com

David Healy, PhD FRCSI

CONTACT

00353876479219; d.healy@svuh.ie

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical SHO

Study Record Dates

• First Submitted: May 21, 2016
• First Posted: October 18, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 16, 2017

Record last verified: 2017-05

Locations

IE (1)