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Completed

NCT Number: NCT03785041

Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

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

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Key information

Conditions

Pain After Knee Arthroscop

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levobupivacaine Hydrochloride 2.5 MG/ML

Drug

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Dec 24, 2018
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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