NCT02782767

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

8 months

First QC Date

May 18, 2016

Last Update Submit

February 5, 2017

Conditions

Upper Gastrointestinal SurgeryPost-operative AnalgesiaWound Infusion CatheterUpper Midline Incision

Outcome Measures

Primary Outcomes (1)

  • NRS (Numerical Rating Score) in the two groups postoperatively

    24 hrs post surgery

Study Arms (2)

Epidural catheter infusion

ACTIVE COMPARATOR

epidural catheter in the thoracic vertebra level to provide local anesthetic infusion

Other: Epidural infusion

Wound catheter infusion

EXPERIMENTAL

A multiorificed wound infusion catheter kept within the incision site to provide continuous local anesthetic infusion

Other: Wound catheter infusion

Interventions

Wound catheter infusionOTHER

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.

Wound catheter infusion
Epidural infusionOTHER

Epidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given

Epidural catheter infusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA PS I-III , undergoing upper gastrointestinal surgery involving upper midline incision

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PGIMER

Chandigarh, Chandigarh, 160012, India

Location

Study Officials

  • Arun Raja Thangavel, MBBS

    Junior Resident , MD Anaesthesia and Intensive care

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Junior Resident

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 25, 2016

Study Start

May 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

IN(1)