Back to resultsLocal Wound Infiltration in Renal Surgery
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
local wound infiltration plus usual care
usual care only
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- ASA I or II, aged between 30 and 65 yr, and undergoing open renal surgery
Exclusion Criteria:
- history of adverse reactions to local anaesthetics, chronic hepatic disease, chronic renal disease chronic pain, chronic preoperative opioid consumption, psychiatric disorders which would prevent postoperative assessments,
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Local wound infiltration
Control
Arm Description
local wound infiltration plus usual care
usual care only
Outcomes
Primary Outcome Measures
Postoperative pain
Visual analogue scale ranging from 0-10 cm where 0 cm
= no pain and 10 cm = the worst imaginable pain.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03601780
Brief Title
Local Wound Infiltration in Renal Surgery
Official Title
Effect of Local Wound Infiltration Plus Usual Care Versus Usual Care Alone on Pain Relief After Open Renal Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Multimodal analgesia is a rational approach to treat various components of postoperative pain.
Detailed Description
Local anesthetic wound infiltration is widely recognized as a useful adjunct during multimodal postoperative pain management whether given before operation or perioperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Local wound infiltration
Arm Type
Active Comparator
Arm Description
local wound infiltration plus usual care
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
usual care only
Intervention Type
Drug
Intervention Name(s)
local wound infiltration plus usual care
Intervention Description
local wound infiltration plus usual care
Intervention Type
Drug
Intervention Name(s)
usual care only
Intervention Description
usual care only
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Visual analogue scale ranging from 0-10 cm where 0 cm
= no pain and 10 cm = the worst imaginable pain.
Time Frame
The first 48 hours after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I or II, aged between 30 and 65 yr, and undergoing open renal surgery
Exclusion Criteria:
history of adverse reactions to local anaesthetics, chronic hepatic disease, chronic renal disease chronic pain, chronic preoperative opioid consumption, psychiatric disorders which would prevent postoperative assessments,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seham M Moeen, MD
Phone
2413201
Ext
088
Email
seham.moeen@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Local Wound Infiltration in Renal Surgery
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