Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia in Cancer Surgery
Effect of Continuous Pre-peritoneal Wound Infiltration Versus Epidural Analgesia on Inflammatory Response and Pain Following Radical Cytsectomy
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2016
CompletedFirst Posted
Study publicly available on registry
December 26, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedOctober 9, 2018
December 1, 2017
1.3 years
December 19, 2016
October 7, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
24 hours
Secondary Outcomes (3)
Visual Analog Scale at rest and on coughing
24 hours
opioid side-effects
24 hours
patient satisfaction
24 hours
Study Arms (2)
epidural group
ACTIVE COMPARATORan 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 group
ACTIVE COMPARATORpreperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision.
Interventions
Eligibility Criteria
You may qualify if:
- ASA I-III patients
- aged 18-60 yr
- undergo open abdominal cancer surgery
You may not qualify if:
- general contraindications for epidural analgesia,
- recent history (8 weeks) of, chemotherapy or radiation,
- chronic opioid use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer instIitute
Asyut, 171516, Egypt
Related Publications (1)
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.
PMID: 30829734DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anesthesia ,icu and pain management
Study Record Dates
First Submitted
December 19, 2016
First Posted
December 26, 2016
Study Start
January 1, 2017
Primary Completion
May 1, 2018
Study Completion
June 1, 2018
Last Updated
October 9, 2018
Record last verified: 2017-12