Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

Overview

Comparison between preemptive and postoperative intraarticular injection of tramadol on pain sensation after arthroscopy

Full Title of Study: “Comparative Study Between Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: December 1, 2017

Detailed Description

220 patients assigned for therapeutic knee arthroscopy were divided into four equal groups in this prospective comparative study. All patients received IAI of 20 ml (0.5%) levopubivacaine alone in Group C; with 100 mg tramadol as PE (Group PE), at end of surgery (Group PO) or divided as 50 mg tramadol + 20 ml 0.25 % levobupivacaine as PE and 50 mg trmadol + 20 ml 0.25 % levobupivacaine as PO (Group PE/PO). Numeric rating scale (NRS) was used to assess pain sensation. Duration till request of rescue analgesia and number of requests were recorded. Patients' satisfaction concerning efficacy of PO analgesia was assessed using Iowa Satisfaction with Anesthesia Scale.

Interventions

  • Drug: Levobupivacaine Hydrochloride 2.5 MG/ML
    • Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative

Arms, Groups and Cohorts

  • Active Comparator: Levobupivacaine and tramadol Preemptive
    • 20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.
  • Active Comparator: Tramadol and levobupivacaine postoperative
    • 20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.
  • Active Comparator: Tramadol and levobupivacaine preemptive and postoperative
    • 20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative.
  • Active Comparator: Levobupivacaine
    • 20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.

Clinical Trial Outcome Measures

Primary Measures

  • Pain control
    • Time Frame: Pain assessment for 12 hours postoperative
    • Pain sensation after arthroscopy assessed by numeric rating scale depending upon patient facial appearance with severe patient expressing high score and no pain with lowest score

Participating in This Clinical Trial

Inclusion Criteria

  • Patient physical status according to American Society of Anesthesiology (ASA) classes I-II – Patients free of general diseases prohibiting the use of local anesthesia. Exclusion Criteria:

  • Patients had allergy for local anesthetics or to tramadol – Patients have psychological or neurological disorders inducing difficulty for evaluation of pain scoring.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 60 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ain Shams University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ayman Anis Metry, Assistant professor – Ain Shams University

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