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

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

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.

Study Overview

• Status: Unknown
• Conditions: Pain
• Intervention / Treatment: Drug: Dexamethasone

Detailed Description

Recent years have seen the importance of early mobility and respiratory toilet to minimise complications and hospital stay. Newer methods of pain relief with fewer systemic effects have become even more important. Continuous wound infiltration catheters (CWI's) aim to deliver local anaesthetic agents directly into the wound (4). This technique goes back to 1994, and has been established in this hospital and is used in a non-structured manner in thoracic surgery. Recent studies have demonstrated that the addition of dexamethasone (a steroid) to local anaesthetic agents in similar nerve blocks significantly improves the analgesic affect and prolongs the duration of the analgesia. To the best of the investigators knowledge this has not been tested in a thoracic surgery cohort of patients, though it has been tested safely and effectively in the thorax in healthy volunteers and in postoperative analgesia in abdominal and musculoskeletal post op patients. The investigators aim is to assess whether the addition of perineural dexamethasone to the local anaesthetic in CWI's is superior to the local anaesthetic alone in thoracic post operative patients, and at which dose. They also want to assess the levels of pain experienced 1 month post op to evaluate the potential effect of dexamethasone on post thoracoscopy pain syndrome.

The investigators aim is to compare the use of local anaesthetic agent in combination with perineural dexamethasone with the current practice of local anaesthetic alone at relieving pain in the immediate post op pain period. The investigators also want to assess whether the 8mg dose of dexamethasone used in similar studies is the optimal dose or whether a similar effect can be observed at a smaller dose of 4mg.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Ireland
  • Leinster
    • Dublin, Leinster, Ireland, Dublin 4
      • Recruiting
      • St Vincent's University Hospital
      • Contact: Mark C Murphy, MB, Bch Bao; Phone Number: 00353877680018; Email: markmurphy1608@gmail.com
      • Contact: David Healy, PHD, FRCS; Phone Number: 00353876479219; Email: d.healy@svuh.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age >18
• Consenting
• undergoing VATS procedure

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Control group will receive normal post operative care including intercostal wound catheters however will not receive dexamethasone
Experimental: Dexamethasone 4mg; 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; perineural infiltration of dexamethasone; Other Names: Dexamethasone phosphate
Experimental: Dexamethasone 8mg; 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; perineural infiltration of dexamethasone; Other Names: Dexamethasone phosphate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reported by patient at 24hrs	Pain according to Visual analog score reported by the patient	recording of patients level of pain 24hrs post op
Pain reported by patient at 48hrs	Pain according to Visual analog score reported by the patient	recording of patients level of pain 48hrs post op
Pain reported by patient 1 month post op	Pain according to Visual analog score reported by the patient	recording of patients level of pain 1 month post op

Collaborators and Investigators

• Sponsor: University College Dublin
• Investigators: Principal Investigator: Mark C Murphy, MB BcH BAO, Surgical SHO

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: May 21, 2016
• First Submitted That Met QC Criteria: October 17, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 15, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Dexamethasone; Dexamethasone acetate; BB 1101; Dexamethasone 21-phosphate
• Other Study ID Numbers: PIL/Consentvs1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided