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

Not Applicable

Completed

• Conditions: Abdominal Neoplasms
• Interventions: Device: preperitoneal catheter; Device: epidural catheter

• Registration Number: NCT03002909
• Lead Sponsor: Assiut University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-21
• Study First Posted: 2016-12-26
• Study Start: 2017-01
• Status Verified: 2017-12
• Primary Completion: 2018-05
• Study Completion: 2018-06
• Last Update Submitted: 2018-10-07
• Last Update Posted: 2018-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
preperitoneal group	preperitoneal catheter	preperitoneal catheters will be placed in the subfascial (ie, pre-peritoneal) space under direct vision.
epidural group	epidural catheter	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. .

Primary Outcome Measures

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

Name	Time	Method
patient satisfaction	24 hours	scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)
Visual Analog Scale at rest and on coughing	24 hours	pain intensity was assessed using a 10-cm VAS (0 = no pain and 10 = worst imaginable pain)
opioid side-effects	24 hours	observation of side effects and record incidence as nausea, vomiting and itching

Trial Locations

Locations (1)

South Egypt Cancer instIitute; 🇪🇬 Assuit, Egypt