Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

Not Applicable

Completed

• Conditions: Pain After Knee Arthroscop
• Interventions: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

• Registration Number: NCT03785041
• Lead Sponsor: Ain Shams University

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 Timeline

• Study Start: 2016-12-21
• Primary Completion: 2017-12-01
• Study Completion: 2018-05-30
• Status Verified: 2018-12
• Study First Submitted: 2018-12-19
• Study First Submitted QC: 2018-12-21
• Study First Posted: 2018-12-24
• Last Update Submitted: 2018-12-24
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tramadol and levobupivacaine preemptive and postoperative	Levobupivacaine Hydrochloride 2.5 MG/ML	20 ml 0.25% Levobupivacaine + 50 mg tramadol injected intraarticular preemptive and postoperative.
Levobupivacaine	Levobupivacaine Hydrochloride 2.5 MG/ML	20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.
Levobupivacaine and tramadol Preemptive	Levobupivacaine Hydrochloride 2.5 MG/ML	20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular preemptive.
Tramadol and levobupivacaine postoperative	Levobupivacaine Hydrochloride 2.5 MG/ML	20 ml 0.5% Levobupivacaine + 100 mg tramadol injected intraarticular postoperative.

Primary Outcome Measures

Name	Time	Method
Pain control	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

Trial Locations

Locations (1)

Ain Shams University; 🇪🇬 Cairo, Egypt