NCT03643757

Brief Summary

Patients operated with posterolateral thoracotomy were enrolled. Post-operative analgesia was provided either by TEA with 0.1% bupivacaine or pethidine based intravenous analgesia (IVA) in our sample population. Perception of pain was quantified by Visual Analogue Scale (VAS) at rest and during coughing. Arterial blood samples were collected at 1st, 24th and 72nd hours of post-operative period. Pre-operative and post-operative 72nd-hour spirometric measurements were recorded

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 23, 2018

Completed
Last Updated

August 23, 2018

Status Verified

August 1, 2018

Enrollment Period

2 years

First QC Date

August 16, 2018

Last Update Submit

August 21, 2018

Conditions

Respiration Disorders

Keywords

Blood gas analysisEpidural analgesiaLung cancerRespiratory function testsThoracotomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative FEV1 and FVC alterations

    Comparison of preoperative and postoperative FEV1 (liters, %) and FVC.(liters, %)

    3 days

Secondary Outcomes (4)

  • Postoperative pH alteration

    24 hours

  • Postoperative pO2 alteration

    24 hours

  • Postoperative pCO2 alteration

    24 hours

  • Postoperative HCO3 concentration alteration

    24 hours

Study Arms (2)

Thoracic Epidural Analgesia

ACTIVE COMPARATOR

Population to whom thoracic epidural analgesia with bupivacaine as a component of multimodal analgesia was administered.

Procedure: Thoracic epidural analgesiaDrug: Bupivacaine

Intravenous analgesia

ACTIVE COMPARATOR

Population to whom combined intravenous analgesia was administered.

Procedure: Thoracic epidural analgesia

Interventions

Thoracic epidural analgesiaPROCEDURE

Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.

Also known as: Posterolateral thorachotomy, Intercostal blockade
Intravenous analgesiaThoracic Epidural Analgesia
BupivacaineDRUG

In addition to multimodal analgesia protocol, epidural bupivacaine was administered in TEA arm and pain relief was achieved by intravenous pethidine infusion in IVA arm.

Also known as: Pethidine intravenous infusion
Thoracic Epidural Analgesia

Eligibility Criteria

Age18 Years - 75 Years
Sexall(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologists -ASA- Class I to III)
  • Scheduled for an elective thoracic surgical procedure with posterolateral thoracotomy

You may not qualify if:

  • Individuals beyond defined age limits
  • Having psychiatric problems
  • Having an auditory deficit
  • Active drug abuse
  • Severe cardiovascular system disorders
  • Severe respiratory depression depicted as having less than 50% of the predicted value of forced expiratory volume
  • Refusing to give consent
  • Contraindication to insertion of an epidural catheter.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Erturk E, Aydogdu Kaya F, Kutanis D, Besir A, Akdogan A, Geze S, Tugcugil E. The effectiveness of preemptive thoracic epidural analgesia in thoracic surgery. Biomed Res Int. 2014;2014:673682. doi: 10.1155/2014/673682. Epub 2014 Mar 13.

    PMID: 24745020RESULT

  • Helander EM, Webb MP, Bias M, Whang EE, Kaye AD, Urman RD. Use of Regional Anesthesia Techniques: Analysis of Institutional Enhanced Recovery After Surgery Protocols for Colorectal Surgery. J Laparoendosc Adv Surg Tech A. 2017 Sep;27(9):898-902. doi: 10.1089/lap.2017.0339. Epub 2017 Jul 25.

    PMID: 28742434RESULT

  • Rawal N. Epidural technique for postoperative pain: gold standard no more? Reg Anesth Pain Med. 2012 May-Jun;37(3):310-7. doi: 10.1097/AAP.0b013e31825735c6.

    PMID: 22531384RESULT

MeSH Terms

Conditions

Respiration DisordersLung Neoplasms

Interventions

TeaBupivacaine

Condition Hierarchy (Ancestors)

Respiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 23, 2018

Study Start

August 1, 2015

Primary Completion

August 1, 2017

Study Completion

March 1, 2018

Last Updated

August 23, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will share

Can be provided on request

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
1 week
Access Criteria
E-mail