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Epidural Analgesia and Postoperative Respiratory Functions (EPAPRES)

NCT03643757 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2018-08-23

No results posted yet for this study

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

Conditions

  • Respiration Disorders

Interventions

PROCEDURE

Thoracic epidural analgesia

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.

DRUG

Bupivacaine

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.

Sponsors & Collaborators

  • Yedikule Training and Research Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2017-08-01
Completion
2018-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03643757 on ClinicalTrials.gov