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

Abdominal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03002909
• Other study ID #: 369
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 2018

Study information

• Verified date: December 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Neoplasms

Intervention

Device:
• epidural catheter

• preperitoneal catheter

Locations

Country	Name	City	State
Egypt	South Egypt Cancer instIitute	Assuit

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	24 hours
Secondary	opioid side-effects	observation of side effects and record incidence as nausea, vomiting and itching	24 hours
Secondary	patient satisfaction	scale ranging 1-4 :unsatisfactory, regular, satisfactory and excellent)	24 hours