Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
Primary Purpose
Upper Gastrointestinal Surgery, Post-operative Analgesia, Wound Infusion Catheter
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Wound catheter infusion
Epidural infusion
Sponsored by
About this trial
This is an interventional other trial for Upper Gastrointestinal Surgery
Eligibility Criteria
Inclusion Criteria:
- ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision
Exclusion Criteria:
- Refusal to give consent.
- Contraindication to epidural analgesia (e.g.localized sepsis , Raised ICP , Myelopathy , Peripheral neuropathy ,Inherited coagulopathy)
- Addiction to opioids, or alcohol, or history of any other substance abuse.
- Allergy to local anaesthetic drugs.
- Pregnancy.
- Inability to communicate (e.g. known psychiatric disorders)
Sites / Locations
- PGIMER
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Epidural catheter infusion
Wound catheter infusion
Arm Description
epidural catheter in the thoracic vertebra level to provide local anesthetic infusion
A multiorificed wound infusion catheter kept within the incision site to provide continuous local anesthetic infusion
Outcomes
Primary Outcome Measures
NRS (Numerical Rating Score) in the two groups postoperatively
Secondary Outcome Measures
Full Information
NCT ID
NCT02782767
First Posted
May 18, 2016
Last Updated
February 5, 2017
Sponsor
Postgraduate Institute of Medical Education and Research, Chandigarh
1. Study Identification
Unique Protocol Identification Number
NCT02782767
Brief Title
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
Official Title
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Postgraduate Institute of Medical Education and Research, Chandigarh
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site}
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Surgery, Post-operative Analgesia, Wound Infusion Catheter, Upper Midline Incision
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Epidural catheter infusion
Arm Type
Active Comparator
Arm Description
epidural catheter in the thoracic vertebra level to provide local anesthetic infusion
Arm Title
Wound catheter infusion
Arm Type
Experimental
Arm Description
A multiorificed wound infusion catheter kept within the incision site to provide continuous local anesthetic infusion
Intervention Type
Other
Intervention Name(s)
Wound catheter infusion
Intervention Description
Wound catheter has multiple holes spread around 360 degrees throughout its active length. It is placed in the musculofascial plane during closure of the wound. Local anaesthetic infusion will be delivered through the catheter.
Intervention Type
Other
Intervention Name(s)
Epidural infusion
Intervention Description
Epidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given
Primary Outcome Measure Information:
Title
NRS (Numerical Rating Score) in the two groups postoperatively
Time Frame
24 hrs post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision
Exclusion Criteria:
Refusal to give consent.
Contraindication to epidural analgesia (e.g.localized sepsis , Raised ICP , Myelopathy , Peripheral neuropathy ,Inherited coagulopathy)
Addiction to opioids, or alcohol, or history of any other substance abuse.
Allergy to local anaesthetic drugs.
Pregnancy.
Inability to communicate (e.g. known psychiatric disorders)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arun Raja Thangavel, MBBS
Organizational Affiliation
Junior Resident , MD Anaesthesia and Intensive care
Official's Role
Principal Investigator
Facility Information:
Facility Name
PGIMER
City
Chandigarh
ZIP/Postal Code
160012
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery
We'll reach out to this number within 24 hrs