Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

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

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

Study Overview

• Status: Completed
• Conditions: Pain After Knee Arthroscop
• Intervention / Treatment: Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

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 Type: Interventional
• Enrollment (Actual): 220
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (Actual): December 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 26, 2018
• Last Update Submitted That Met QC Criteria: December 24, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Preemptive; Levobupivacaine; Tramadol; Intra-articular injection; post-arthroscopy pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Tramadol; Levobupivacaine
• Other Study ID Numbers: ASUH7923/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No