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

Comparison of efficacy in management of pain in abdominal surgery between epidural versus wound infusion catheter {catheter placed within the incision site}

Study Overview

• Status: Completed
• Conditions: Post-operative Analgesia; Upper Gastrointestinal Surgery; Wound Infusion Catheter; Upper Midline Incision
• Intervention / Treatment: Other: Epidural infusion; Other: Wound catheter infusion

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Chandigarh, India, 160012
    • PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural catheter infusion; epidural catheter in the thoracic vertebra level to provide local anesthetic infusion	Other: Epidural infusion; Epidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given
Experimental: Wound catheter infusion; A multiorificed wound infusion catheter kept within the incision site to provide continuous local anesthetic infusion	Other: Wound catheter infusion; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
NRS (Numerical Rating Score) in the two groups postoperatively	24 hrs post surgery

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research, Chandigarh
• Investigators: Principal Investigator: Arun Raja Thangavel, MBBS, Junior Resident , MD Anaesthesia and Intensive care

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: May 18, 2016
• First Submitted That Met QC Criteria: May 21, 2016
• First Posted (Estimate): May 25, 2016

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 5, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: MDTG105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED