Preemptive and Postoperative Intra-articualr Injection of Levobupivacaine and Tramadol

NCT03785041 | Completed

• 1 other identifier: ASUH7923/16
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain After Knee Arthroscop

Keywords

Tramadol; Intra-articular injection; Preemptive; post-arthroscopy pain; Levobupivacaine

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Levobupivacaine and tramadol Preemptive

ACTIVE COMPARATOR

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

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Tramadol and levobupivacaine postoperative

ACTIVE COMPARATOR

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

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Tramadol and levobupivacaine preemptive and postoperative

ACTIVE COMPARATOR

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

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Levobupivacaine

ACTIVE COMPARATOR

20 ml 0.5% Levobupivacaine only injected intraarticular preemptive.

Drug: Levobupivacaine Hydrochloride 2.5 MG/ML

Interventions

Levobupivacaine Hydrochloride 2.5 MG/ML DRUG

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

Also known as: Tramadol 50 MG/ML, Tramadol 100 MG/ML, Levobupivacaine Hydrochloride 5MG/ML

Levobupivacaine; Levobupivacaine and tramadol Preemptive; Tramadol and levobupivacaine postoperative; Tramadol and levobupivacaine preemptive and postoperative

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient physical status according to American Society of Anesthesiology (ASA) classes I-II
• Patients free of general diseases prohibiting the use of local anesthesia.

You may not qualify if:

• Patients had allergy for local anesthetics or to tramadol
• Patients have psychological or neurological disorders inducing difficulty for evaluation of pain scoring.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Interventions

Levobupivacaine; Tramadol

Intervention Hierarchy (Ancestors)

Bupivacaine; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: December 24, 2018
• Study Start: December 21, 2016
• Primary Completion: December 1, 2017
• Study Completion: May 30, 2018
• Last Updated: December 26, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)