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Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

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ClinicalTrials.gov Identifier: NCT03785041
Recruitment Status : Completed
First Posted : December 24, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Ayman Anis Metry, Ain Shams University

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

Condition or disease Intervention/treatment Phase
Pain After Knee Arthroscop Drug: Levobupivacaine Hydrochloride 2.5 MG/ML Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparative Study Between Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol
Actual Study Start Date : December 21, 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
Active Comparator: Levobupivacaine and tramadol Preemptive
20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.
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

Active Comparator: Tramadol and levobupivacaine postoperative
20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.
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

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

Active Comparator: Levobupivacaine
20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785041


Locations
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Egypt
Ain Shams University
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University

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Responsible Party: Ayman Anis Metry, Assistant professor, Ain Shams University
ClinicalTrials.gov Identifier: NCT03785041     History of Changes
Other Study ID Numbers: ASUH7923/16
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ayman Anis Metry, Ain Shams University:
Tramadol
Intra-articular injection
Preemptive
post-arthroscopy pain
Levobupivacaine
Additional relevant MeSH terms:
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Tramadol
Levobupivacaine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Local
Anesthetics