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Post Operative PainNCT05249478

Pain Management After Total Knee Replacement

A study testing bupivacaine and fentanyl in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Post Operative Pain
What is being tested?
bupivacaine and fentanyl
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteEgypt
Study dates
5 Feb 2022to Aug 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • .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.

Trial locations and contacts

1 site in 1 country.

Remon Nadhy, MSC contact

01285538420

remonnadhy@yahoo.com

Egypt1 site, 1 recruiting
  • Ain Shams University Hospitals

    Cairo, 11591

    Remon Nadhy, MSC, 01285538420, remonnadhy@med.asu.edu.eg

    Amr Gaber, 01005013194, dramrgaber7@gmail.com

    Recruiting

Other trials in Egypt

About this study

Official title: A Comparative Study Between Continuous Epidural Analgesia Versus Ultrasound Guided Continuous Femoral Nerve Block (CFNB) Versus Ultrasound Guided Continuous Adductor Canal Block (ACB) for Post-operative Pain Management After Total Knee Replacement (TKR).

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.

Read the detailed description

All patients will be assessed preoperatively, and will be instructed to fast for 8 hrs. On arrival to the operation theatre, Intravenous access will be established, and Ringer's solution will be infused as a co-load fluid bolus. Monitors for non-invasive blood pressure, heart rate, electrocardiogram (ECG), and pulse oximetry (SpO2) will be used to monitor the perioperative vital parameters of patients.

Before the spinal anesthesia, the epidural catheter will be inserted, while the femoral and adductor canal catheters will be inserted under ultrasound guidance before spinal anesthesia according to patient group allocation by single operator.

Group A: 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.

The epidural needle (typically 18-gauge and 8.89 cm (3.5 inches) in length) is inserted in the midline of the patient's back, defined by the spinous processes at the chosen spinal level. A skin wheal is raised with 1% lidocaine using a 25-gauge needle in the midline of the spine, in the lower third to half of the interspace. The subcutaneous tissue is infiltrated with lidocaine and is continued through supraspinous ligament down to the interspinous ligament.

The epidural needle is inserted with stylet at a straight or slight cephalad angle or at steeper cephalad angle. The needle bevel is oriented cephalad while the patient is in a sitting position. The needle is advanced through the supraspinous ligament and into the interspinous ligament. A firmness in the tissue suggests that the tip of the needle is in the supraspinous or interspinous ligament. Lack of firmness may indicate a paraspinous position of the needle tip, and the needle should be adjusted.

Once the needle tip is anchored in the interspinous ligament, the stylet is removed and a loss of resistance (LOR) syringe containing air is attached. Intermittent or continuous gentle pressure is applied to the plunger with the dominant thumb, while advancing the needle slowly with the nondominant hand. The ligamentum flavum is a tougher structure than the interspinous ligament and is identified by increased resistance to injection as the needle is advanced. Once LOR occurs, needle advancement is stopped to avoid an unintentional dural puncture.

The tip of the epidural needle is now located in 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.

Group B: 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 (femoral nerve lateral or posterolateral to femoral artery at the level of the femoral triangle).

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). Then 5 mL of lidocaine 1% will be injected through the needle under ultrasound guidance to confirm placement and inject the rest of the bolus through the catheter while visualizing spread of LA after removal of the needle. The catheter is secured to the skin with a sterile dressing after applying a sterile surgical glue.

Group C: As for the adductor canal block, it will be performed under complete aseptic precautions, 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 adductor canal is roofed by sartorius muscle and bounded medially by adductor longus muscle and laterally by vastus medialis muscle.

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.

5 ml of LA will be injected through the needle under ultrasound guidance to confirm placement and inject the rest of the bolus through the catheter while visualizing spread of LA. The catheter is secured to the skin with a sterile dressing after applying a sterile surgical glue.

In the three groups, Rescue doses of intravenous fentanyl will be given intravenously (IV) to the patient if there is still pain during positioning, increments of 50 microgram fentanyl (0.5 microgram/kg) and sedation score will be assessed and recorded.

Spinal anesthesia will be administered in the sitting position under complete aseptic conditions using a 25-gauge Quincke needle through L3-L4 or L4-L5 intervertebral space with 2 to 3.5 ml of 0.5% heavy bupivacaine and 25 microgram fentanyl with injection rate of 0.2 mL/second.

After confirmation of the start of sensory block, the level of the sensory block will be documented, and surgery will be allowed to start.

During operation, if any patient felt discomfort from the position or from the surgery, increments of fentanyl will be given IV and total intraoperative fentanyl will be recorded, and the surgery time will also be documented.

  • Patients will be observed for any complications either related to the procedure e.g.: hematomas or related to drugs injected e.g.: hypotension, bradycardia, fall in peripheral oxygen saturation, nausea, vomiting or any other adverse effect and will be managed along with proper systematic assessment to exclude serious causes for any vital sign derangement .
  • In case of hypotension (drop of blood pressure ˃20% of baseline reading), 3 mg increments of a 30 mg of ephedrine diluted with 10 ml normal saline 0.9% will be given intravenously by titration according to the blood pressure, along with 250 to 500 mL Ringer acetate as a fluid bolus if not contraindicated.
  • In case of bradycardia, when it is associated with hypotension or any signs of impaired perfusion, 0.01 mg/kg of atropine will be given IV and repeated if needed.
  • In case of fall in peripheral SpO2, supplemental oxygen will be given to keep SpO2 above 94%.
  • In case of postoperative nausea and vomiting (PONV), 4 mg of ondansetron diluted with 10 ml normal saline 0.9% will be given intravenously slowly over 10 minutes.
  • Postoperatively, continuous infusion of 0.125% bupivacaine with fentanyl 2µg/ml will be started through PCA at a fixed rate of 5 ml/hr. in the three groups
  • Patients will be observed, and data recording will be done at 0,1,6,12,24,36 and 48 hours for postoperative pain scores, hemodynamic changes (blood pressure, heart rate and respiratory rate) and side effects such as pruritis, urine retention, nausea, vomiting and excessive motor block that prevents safe assisted or unassisted early postoperative mobilization. And the requirement of analgesic doses for the first 24 hours after the surgery will be noted.
  • Postoperative pain and opioid consumption will be assessed after regaining of sensation in the contralateral limb by using visual analog scale (VAS) and VAS more than 3 will be managed by top up dose of 5ml.
Being tested
bupivacaine and fentanyl
Keywords
epidural , adductor canal block, femoral nerve block, total knee replacement
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bupivacaine and fentanylProcedure or surgery

    bupivacaine and fentanyl will be infused through the catheter

Study groups in NCT05249478
Study groupRoleWhat they receive
epidural catheter inserted before spinal anesthesia.Active comparatorAs 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.
Receives: Procedure: bupivacaine and fentanyl
ultrasound guided femoral nerve catheter inserted before spinal anesthesia.Active comparatorAs 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).
Receives: Procedure: bupivacaine and fentanyl
ultrasound guided adductor canal block inserted before spinal anesthesia.Active comparatorAs 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.
Receives: Procedure: bupivacaine and fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain score

    Visual analogue score from 0 to 10

    Measured: 48 hours

Secondary outcomes (2)
  1. hemodynamic changes

    blood pressure in mmhg

    Measured: 48 hours

  2. hemodynamic changes

    heart rate per minute

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Feb 2022
  2. Study start5 Feb 2022
  3. Primary completionJul 2022 (estimated)
  4. Study completionAug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05249478
Sponsor's protocol ID
Ain Shams Universirty
Status last verified
Jul 2022
First submitted
25 Nov 2021
Last updated
15 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: There is a plan to make IPD and related data dictionaries available.

Publications

  • 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.

    PubMed 31056239

Questions about this trial

What is this clinical trial studying?

A study testing bupivacaine and fentanyl in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Remon Nadhy, MSC (01285538420, remonnadhy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain score (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05249478, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2022.

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