Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

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

Detailed Description
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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.

Official Title
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Comparative Study Between Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

Conditions
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Pain After Knee Arthroscop

Intervention / Treatment
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* Drug: Levobupivacaine Hydrochloride 2.5 MG/ML


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levobupivacaine and tramadol Preemptive<br>20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive. | Drug: Levobupivacaine Hydrochloride 2.5 MG/ML<br>* Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative<br>* Other names: Levobupivacaine Hydrochloride 5MG/ML;|
| Active Comparator: Tramadol and levobupivacaine postoperative<br>20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative. | Drug: Levobupivacaine Hydrochloride 2.5 MG/ML<br>* Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative<br>* Other names: Levobupivacaine Hydrochloride 5MG/ML;|
| Active Comparator: Tramadol and levobupivacaine preemptive and postoperative<br>20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative. | Drug: Levobupivacaine Hydrochloride 2.5 MG/ML<br>* Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative<br>* Other names: Levobupivacaine Hydrochloride 5MG/ML;|
| Active Comparator: Levobupivacaine<br>20 ml 0.5% Levobupivacaine only injected intraarticular preemptive. | Drug: Levobupivacaine Hydrochloride 2.5 MG/ML<br>* Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative<br>* Other names: Levobupivacaine Hydrochloride 5MG/ML;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain control | 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 | Pain assessment for 12 hours postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tramadol, Intra-articular injection, Preemptive, post-arthroscopy pain, Levobupivacaine