NCT03309267

Brief Summary

Pain after thoracotomy is the most severe pain experienced by the patient. Good pain control after the operation provides comfortable respiration and reduces the development of chronic pain and complications. we aimed to compare SAPB with IBregarding postoperative visual analog scale (VAS) scores and analgesic consumption in patients undergoing thoracotomy operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 6, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 6, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 13, 2017

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2017

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

28 days

First QC Date

October 6, 2017

Last Update Submit

November 3, 2017

Conditions

Keywords

pain, thoracotomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesic consumption

    Postoperative analgesic consumption

    up to 24 hour

Secondary Outcomes (1)

  • Visuel analog scala (VAS)

    up to 24 hour

Other Outcomes (1)

  • Complications

    Postoperative 1 week

Study Arms (2)

Intercostal block

Anesthesia induction was performed to all patients .At the end of the operation some patients were performed with intercostal block by the chest surgeon. For 24 hours postoperatively, tramadol was administered with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU.

Procedure: Intercostal block

Serratus anterior plane block

Anesthesia induction was performed to all patients. At the end of the operation some patients were performed SAPB under Ultrasound guidance by the same anesthetist.For 24 hours postoperatively, tramadol was administered with patient-controlled analgesia (PCA) All patients were extubated after the operation and transferred to ICU.

Procedure: Serratus anterior plane block

Interventions

Intercostal block +patient controlled analgesia

Intercostal block

Serratus anterior plane block+patient controlled analgesia

Serratus anterior plane block

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Thoracotomy Operation

You may qualify if:

  • Thoracotomy operation
  • a.Serratus anaterior plane block b.Intercostal block

You may not qualify if:

  • missing data
  • written consent
  • rethoracotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KahramanmarasSIU

Kahramanmaraş, 46100, Turkey (Türkiye)

Location

Related Publications (1)

  • Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.

    PMID: 28447227BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gözen Öksüz

    Kahramanmaras Sutcu Imam University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 6, 2017

First Posted

October 13, 2017

Study Start

October 6, 2017

Primary Completion

November 3, 2017

Study Completion

November 3, 2017

Last Updated

November 7, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations