Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery

Effect of Lidocaine 5% Patch Supplementation to Intra-articular Bupivacaine Dexmedetomidine After Arthroscopic Knee Surgery Under General Anesthesia

Surgery of the knee is a very common procedure which can be very painful and sufficient postoperative pain treatment is often problematic. The aim of this work was to study the effects of supplementation of intra-articular bupivacaine dexmedetomidine with lidocaine 5% patch after arthroscopic knee surgery under general anesthesia and its role in improving quality of anesthesia.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Arthroscopic Knee Surgery; Lidocaine 5% Patch; Intra-articular
• Intervention / Treatment: Drug: Dexmedetomidine Bupivacaine; Drug: Lidocaine 5% patch with Dexmedetomidine Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

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:

• Adult patients
• ASA I & II
• Aged between 18 to 60 years
• Weight between 60 to 100 kg
• Scheduled for elective arthroscopic knee surgery

Exclusion Criteria:

• patient refusal.
• history of cardiac disease.
• impaired renal or hepatic function.
• hypertension treated with α methyldopa, clonidine, or beta-adrenergic blockers.
• if they have used opioid analgesics within the previous 24 hr.
• previous sensitivity to local anesthetics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (control group); Patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly without lidocaine patch	Drug: Dexmedetomidine Bupivacaine; 10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique without a patch of lidocaine 5%
Experimental: Group B; Patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly with a patch of lidocaine 5% was applied to the skin	Drug: Lidocaine 5% patch with Dexmedetomidine Bupivacaine; 10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique and a patch of lidocaine 5% was applied to the skin between the arthroscopic ports

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of postoperative pethidine consumption	The total dose of postoperative pethidine consumption; Pethidine 20 mg was given as rescue analgesia if pain visual analogue visual analogue scale (VAS) ≥4.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First postoperative analgesia request time	First postoperative analgesia (Pethidine 20 mg) request time	24 hours
Pain intensity	Visual analogue scale (VAS) was recorded immediately postoperative and at 30 min, 1, 2, 4, 6, 12 and 24 hours postoperatively. The score ranges from 0 to 10; higher means worse pain	24 hours

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Membrane Transport Modulators; Hypnotics and Sedatives; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Dexmedetomidine; Lidocaine; Bupivacaine
• Other Study ID Numbers: 31084/07/16

Drug and device information, study documents

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