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

NCT ID: NCT04322760

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-01
• Study Completion Date: 2017-12-01

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.

Conditions

Dexmedetomidine; Lidocaine 5% Patch; Arthroscopic Knee Surgery; Intra-articular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine Bupivacaine

Intervention Type: DRUG

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%

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

Group Type: EXPERIMENTAL

Lidocaine 5% patch with Dexmedetomidine Bupivacaine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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%

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Said Elgebaly,MD

Assistant professor of Anesthesiology, Surgical Intensive Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

31084/07/16

Identifier Type: -

Identifier Source: org_study_id