Local Wound Infiltration in Renal Surgery

Overview

Multimodal analgesia is a rational approach to treat various components of postoperative pain.

Full Title of Study: “Effect of Local Wound Infiltration Plus Usual Care Versus Usual Care Alone on Pain Relief After Open Renal Surgery.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2018

Detailed Description

Local anesthetic wound infiltration is widely recognized as a useful adjunct during multimodal postoperative pain management whether given before operation or perioperatively.

Interventions

  • Drug: local wound infiltration plus usual care
    • local wound infiltration plus usual care
  • Drug: usual care only
    • usual care only

Arms, Groups and Cohorts

  • Active Comparator: Local wound infiltration
    • local wound infiltration plus usual care
  • Placebo Comparator: Control
    • usual care only

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative pain
    • Time Frame: The first 48 hours after surgery
    • Visual analogue scale ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.

Participating in This Clinical Trial

Inclusion Criteria

  • ASA I or II, aged between 30 and 65 yr, and undergoing open renal surgery Exclusion Criteria:

  • history of adverse reactions to local anaesthetics, chronic hepatic disease, chronic renal disease chronic pain, chronic preoperative opioid consumption, psychiatric disorders which would prevent postoperative assessments,

Gender Eligibility: All

Minimum Age: 30 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assiut University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Seham Mohamed Moeen Ibrahim, lecturer – Assiut University
  • Overall Contact(s)
    • Seham M Moeen, MD, 2413201, seham.moeen@yahoo.com

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