Pain Management After Total Knee Replacement

NCT05249478 | Unknown DMC

• 1 other identifier: Ain Shams Universirty
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to compare post-operative analgesic efficacy of continuous epidural analgesia versus ultrasound guided continuous femoral nerve block and adductor nerve block after unilateral total knee replacement using 0.125% bupivacaine.

Conditions

Post Operative Pain

Keywords

epidural , adductor canal block, femoral nerve block, total knee replacement

Outcome Measures

Primary Outcomes (1)

• pain score

  Visual analogue score from 0 to 10

  48 hours

Secondary Outcomes (2)

• hemodynamic changes

  48 hours

• hemodynamic changes

  48 hours

Study Arms (3)

epidural catheter inserted before spinal anesthesia.

ACTIVE COMPARATOR

As for the epidural analgesia, it will be performed under complete aseptic precautions, by introducing a needle between the lumbar vertebrae at level of L3-L4 or L4-L5 and injecting anesthetic medication into the epidural space, via the epidural catheter inserted through the needle into the epidural space. A small amount of air (1 to 2 mL) may be injected into the epidural space, avoid injecting larger amounts of air as this may contribute to patchy anesthesia.

Procedure: bupivacaine and fentanyl

ultrasound guided femoral nerve catheter inserted before spinal anesthesia.

ACTIVE COMPARATOR

As for the femoral nerve block, it will be performed under complete aseptic precautions, using a transportable Sonosite M-Turbo ultrasound system with linear transducer placed on the femoral crease to obtain the images of the femoral nerve \& artery. The needle used for the block will be an echogenic needle of 18 Gauge and 3.5 inches. Before proceeding, skin infiltration with local anesthesia will be done using a syringe containing 5ml of 1% lidocaine, Once the femoral nerve is visualized, the needle will be inserted in-plane in a lateral to medial orientation and advanced towards the nerve. Once the tip placed adjacent to the nerve, the catheter is introduced through it, then the needle is removed, the location of the catheter can be confirmed by visualization of the catheter and spread of local anesthetic (LA).

Procedure: bupivacaine and fentanyl

ultrasound guided adductor canal block inserted before spinal anesthesia.

ACTIVE COMPARATOR

As for the adductor canal block,using a transportable Sonosite M-Turbo ultrasound system with linear transducer placed perpendicular to the thigh at the midpoint between the anterior superior iliac spine and the base of the patella,The needle used for the block will be an echogenic needle of 18 Gauge and 3.5 inches. Before proceeding, skin infiltration with local anesthesia will be done using a syringe containing 5ml of 1% lidocaine, the saphenous nerve is identified as it lies adjacent proximally lateral then distally superior to the femoral artery. Saphenous nerve is followed distally as it becomes more superficial, traveling with an arterial branch just deep to the sartorius muscle. Using an in-plane approach, after negative aspiration, the tip of the needle is placed deep to the sartorius muscle, at the lateral border of the artery, Once the needle is in position, the catheter is introduced through it, then the needle is removed.

Procedure: bupivacaine and fentanyl

Interventions

bupivacaine and fentanyl PROCEDURE

bupivacaine and fentanyl will be infused through the catheter

epidural catheter inserted before spinal anesthesia.; ultrasound guided adductor canal block inserted before spinal anesthesia.; ultrasound guided femoral nerve catheter inserted before spinal anesthesia.

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists physical status (ASA) is I to III. .Both genders. .More than 40 years old.

You may not qualify if:

• Major spine deformities. .Bleeding disorders and coagulopathy. .Infection at the injection site. .Allergy to local anesthetics. .Pre-existing myopathy or neuropathy. .Significant cognitive dysfunction. .Patient refusal to participate.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 11591, Egypt

RECRUITING

Related Publications (1)

• Chuan A, Lansdown A, Brick KL, Bourgeois AJG, Pencheva LB, Hue B, Goddard S, Lennon MJ, Walters A, Auyong D; Continuous Catheters in Adductor Canal versus Femoral Triangle (The CAFE study) investigators. Adductor canal versus femoral triangle anatomical locations for continuous catheter analgesia after total knee arthroplasty: a multicentre randomised controlled study. Br J Anaesth. 2019 Sep;123(3):360-367. doi: 10.1016/j.bja.2019.03.021. Epub 2019 May 2.

  PMID: 31056239 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Bupivacaine; Fentanyl

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Remon Nadhy, MSC

CONTACT

01285538420; remonnadhy@yahoo.com

Amr Gaber, MD

CONTACT

01005013194; dramrgaber7@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: February 21, 2022
• Study Start: February 5, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within one year
• Access Criteria: open

Locations

EG (1)