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Completed

NCT Number: NCT03002909

Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery

the investigators aim is to investigate the effect of continuous preperitoneal bupivacaine wound infiltration versus epidural analgesia on the inflammatory cytokines response following radical cytectomy

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Key information

Conditions

Abdominal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

South Egypt Cancer instIitute

Asyut, 171516, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA I-III patients
  • aged 18-60 yr
  • undergo open abdominal cancer surgery

Exclusion criteria

  • general contraindications for epidural analgesia,
  • recent history (8 weeks) of, chemotherapy or radiation,
  • chronic opioid use

Treatment and study plan

Epidural catheter

Device

Other names: PEA block

preperitoneal catheter

Device

Other names: preperitoneal infusion

Primary outcomes

  1. changes in the level of inflammatory cytokines in pg /ml

    Time frame: 24 hours

    Blood samples taken all over the 24-hr. period were collected in plasma tubes containing ethyl-enediamine-tetra-acectic (EDTA), centrifuged and stored at 20○c for assessment of Plasma concentrations plasma IL 1, IL 6, IL10 and TNF to assess inflammatory cytokines

Secondary outcomes

  1. Visual Analog Scale at rest and on coughing

    Time frame: 24 hours

    pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain)

  2. opioid side-effects

    Time frame: 24 hours

    observation of side effects and record incidence as nausea, vomiting and itching

  3. patient satisfaction

    Time frame: 24 hours

    scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 26, 2016
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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