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Trial record 35 of 485 for:    TRAMADOL

Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03785041
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : December 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ayman Anis Metry, Ain Shams University

Tracking Information
First Submitted Date  ICMJE December 19, 2018
First Posted Date  ICMJE December 24, 2018
Last Update Posted Date December 26, 2018
Actual Study Start Date  ICMJE December 21, 2016
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol
Official Title  ICMJE Comparative Study Between Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol
Brief Summary Comparison between preemptive and postoperative intraarticular injection of tramadol on pain sensation after arthroscopy
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Pain After Knee Arthroscop
Intervention  ICMJE Drug: Levobupivacaine Hydrochloride 2.5 MG/ML
Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative
Other Names:
  • Tramadol 50 MG/ML
  • Tramadol 100 MG/ML
  • Levobupivacaine Hydrochloride 5MG/ML
Study Arms  ICMJE
  • Active Comparator: Levobupivacaine and tramadol Preemptive
    20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.
    Intervention: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML
  • Active Comparator: Tramadol and levobupivacaine postoperative
    20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.
    Intervention: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML
  • Active Comparator: Tramadol and levobupivacaine preemptive and postoperative
    20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative.
    Intervention: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML
  • Active Comparator: Levobupivacaine
    20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.
    Intervention: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 21, 2018)
220
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 30, 2018
Actual Primary Completion Date December 1, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03785041
Other Study ID Numbers  ICMJE ASUH7923/16
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ayman Anis Metry, Ain Shams University
Study Sponsor  ICMJE Ain Shams University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Ain Shams University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP