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

NCT ID: NCT03002909

Last Updated: 2018-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-06-30

Brief Summary

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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

Detailed Description

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Conditions

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Abdominal Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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. .

Group Type ACTIVE_COMPARATOR

epidural catheter

Intervention Type DEVICE

preperitoneal group

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

Group Type ACTIVE_COMPARATOR

preperitoneal catheter

Intervention Type DEVICE

Interventions

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epidural catheter

Intervention Type DEVICE

preperitoneal catheter

Intervention Type DEVICE

Other Intervention Names

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PEA block preperitoneal infusion

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Adel El sherif,MD

lecturer of anesthesia ,icu and pain management

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fatma el sherif, M.D

Role: PRINCIPAL_INVESTIGATOR

south Egypt cancer institute - assuit university

Ahmad M Abd El-Rahman, M.D

Role: STUDY_DIRECTOR

Lecturer of anesthesia, icu, and pain management

Locations

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South Egypt Cancer instIitute

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 30829734 (View on PubMed)

Other Identifiers

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369

Identifier Type: -

Identifier Source: org_study_id

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