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

NCT04322760 | Completed

• 1 other identifier: 31084/07/16
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• First postoperative analgesia request time

  24 hours

• Pain intensity

  24 hours

Study Arms (2)

Group A (control group)

ACTIVE COMPARATOR

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

Group B

EXPERIMENTAL

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

Interventions

Lidocaine 5% patch with Dexmedetomidine Bupivacaine 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

Group B

Dexmedetomidine Bupivacaine 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 A (control group)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

MeSH Terms

Interventions

Lidocaine; Transdermal Patch

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of Anesthesiology, Surgical Intensive Care

Model Details: 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.

Study Record Dates

• First Submitted: March 24, 2020
• First Posted: March 26, 2020
• Study Start: December 1, 2016
• Primary Completion: November 30, 2017
• Study Completion: December 1, 2017
• Last Updated: March 27, 2020

Record last verified: 2020-03