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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Dexmedetomidine, Lidocaine 5% Patch, Arthroscopic Knee Surgery, Intra-articular

Intervention / Treatment
-----------------
* Drug: Lidocaine 5% patch with Dexmedetomidine Bupivacaine
* Drug: Dexmedetomidine Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were allocated into 2 groups, 20 patients in each received 10 ml 0.5 % bupivacaine and 1µg/kg dexmedetomidine diluted in 10 ml saline injected intra-articularly; group A: no patch, group B: a patch of lidocaine 5% was applied to the skin.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (control group)<br>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<br>* 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%<br>|
| Experimental: Group B<br>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<br>* 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<br>|

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 |