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Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

NCT ID: NCT03785041

Last Updated: 2018-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-21

Study Completion Date

2018-05-30

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.

Conditions

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Pain After Knee Arthroscop

Keywords

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Tramadol Intra-articular injection Preemptive post-arthroscopy pain Levobupivacaine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Levobupivacaine and tramadol Preemptive

20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.

Group Type ACTIVE_COMPARATOR

Levobupivacaine Hydrochloride 2.5 MG/ML

Intervention Type DRUG

Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative

Tramadol and levobupivacaine postoperative

20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.

Group Type ACTIVE_COMPARATOR

Levobupivacaine Hydrochloride 2.5 MG/ML

Intervention Type DRUG

Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative

Tramadol and levobupivacaine preemptive and postoperative

20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative.

Group Type ACTIVE_COMPARATOR

Levobupivacaine Hydrochloride 2.5 MG/ML

Intervention Type DRUG

Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative

Levobupivacaine

20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.

Group Type ACTIVE_COMPARATOR

Levobupivacaine Hydrochloride 2.5 MG/ML

Intervention Type DRUG

Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative

Interventions

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Levobupivacaine Hydrochloride 2.5 MG/ML

Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative

Intervention Type DRUG

Other Intervention Names

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Tramadol 50 MG/ML Tramadol 100 MG/ML Levobupivacaine Hydrochloride 5MG/ML

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Ayman Anis Metry

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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ASUH7923/16

Identifier Type: -

Identifier Source: org_study_id