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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
Postgraduate Institute of Medical Education and Research, Chandigarh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Upper Gastrointestinal Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
May 18, 2016
Last Updated
February 5, 2017
Sponsor
Postgraduate Institute of Medical Education and Research, Chandigarh
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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

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Comparison of Continuous Wound Catheter Infusion Versus Continuous Epidural Infusion in Abdominal Surgery

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