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

October 7, 2018 updated by: Fatma Adel El sherif,MD, Assiut University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assuit, Egypt, 171516
        • South Egypt Cancer instIitute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: epidural group
an epidural catheter will be inserted under sterile conditions through the T9- 12 interspace using the 'loss-of-resistance' technique. The catheter will be advanced 4 cm cephalad. .
Device: epidural catheter
Other Names:
  • PEA block
Active Comparator: preperitoneal group
preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision.
Device: preperitoneal catheter
Other Names:
  • preperitoneal infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours
opioid side-effects
Time Frame: 24 hours
observation of side effects and record incidence as nausea, vomiting and itching
24 hours
patient satisfaction
Time Frame: 24 hours
scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: fatma el sherif, M.D, south Egypt cancer institute - assuit university
  • Study Director: Ahmad M Abd El-Rahman, M.D, Lecturer of anesthesia, icu, and pain management

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2017

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

December 19, 2016

First Submitted That Met QC Criteria

December 21, 2016

First Posted (Estimate)

December 26, 2016

Study Record Updates

Last Update Posted (Actual)

October 9, 2018

Last Update Submitted That Met QC Criteria

October 7, 2018

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 369

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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