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

Primary Purpose

Abdominal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
epidural catheter
preperitoneal catheter
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Abdominal Neoplasms

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • South Egypt Cancer instIitute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

epidural group

preperitoneal group

Arm Description

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. .

preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision.

Outcomes

Primary Outcome Measures

changes in the level of inflammatory cytokines in pg /ml
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 Outcome Measures

Visual Analog Scale at rest and on coughing
pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain)
opioid side-effects
observation of side effects and record incidence as nausea, vomiting and itching
patient satisfaction
scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)

Full Information

First Posted
December 19, 2016
Last Updated
October 7, 2018
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT03002909
Brief Title
Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery
Official Title
Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
June 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Neoplasms

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
epidural group
Arm Type
Active Comparator
Arm Description
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. .
Arm Title
preperitoneal group
Arm Type
Active Comparator
Arm Description
preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision.
Intervention Type
Device
Intervention Name(s)
epidural catheter
Other Intervention Name(s)
PEA block
Intervention Type
Device
Intervention Name(s)
preperitoneal catheter
Other Intervention Name(s)
preperitoneal infusion
Primary Outcome Measure Information:
Title
changes in the level of inflammatory cytokines in pg /ml
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Visual Analog Scale at rest and on coughing
Description
pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain)
Time Frame
24 hours
Title
opioid side-effects
Description
observation of side effects and record incidence as nausea, vomiting and itching
Time Frame
24 hours
Title
patient satisfaction
Description
scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatma el sherif, M.D
Organizational Affiliation
south Egypt cancer institute - assuit university
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahmad M Abd El-Rahman, M.D
Organizational Affiliation
Lecturer of anesthesia, icu, and pain management
Official's Role
Study Director
Facility Information:
Facility Name
South Egypt Cancer instIitute
City
Assuit
ZIP/Postal Code
171516
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30829734
Citation
Othman AH, Ahmed DG, Abd El-Rahman AM, El Sherif FA, Mansour S, Aboeleuon E. Effect of Preperitoneal Versus Epidural Analgesia on Postoperative Inflammatory Response and Pain Following Radical Cystectomy: A Prospective, Randomized Trial. Clin J Pain. 2019 Apr;35(4):328-334. doi: 10.1097/AJP.0000000000000679.
Results Reference
derived

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

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