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

Post-operative Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02782767
• Other study ID #: MDTG105
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: February 5, 2017
• Start date: May 2016
• Est. completion date: January 2017

Study information

• Verified date: February 2017
• Source: Postgraduate Institute of Medical Education and Research, Chandigarh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Post-operative Analgesia
• Upper Gastrointestinal Surgery
• Upper Midline Incision
• Wound Infusion Catheter
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
India	PGIMER	Chandigarh

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research, Chandigarh

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS (Numerical Rating Score) in the two groups postoperatively		24 hrs post surgery