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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
Egypt1 site, 1 recruiting
- Recruiting
Ain Shams University Hospitals
Cairo, 11591
Remon Nadhy, MSC, 01285538420, remonnadhy@med.asu.edu.eg
Amr Gaber, 01005013194, dramrgaber7@gmail.com
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.
- Conditions
- Post Operative Pain
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Procedure: bupivacaine and fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score
Visual analogue score from 0 to 10
Measured: 48 hours
Secondary outcomes (2)
hemodynamic changes
blood pressure in mmhg
Measured: 48 hours
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.
- First posted21 Feb 2022
- Study start5 Feb 2022
- Primary completionJul 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, remon nadhy, Ain Shams University
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT05249478
- Acronym / sponsor ID
- Ain Shams Universirty
- Conditions
- Post Operative Pain
- Keywords
- epidural , adductor canal block, femoral nerve block, total knee replacement
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 5 Feb 2022 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 21 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| epidural catheter inserted before spinal anesthesia. | Active comparator | Procedure: bupivacaine and fentanylAs 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. |
| ultrasound guided femoral nerve catheter inserted before spinal anesthesia. | Active comparator | Procedure: bupivacaine and fentanylAs 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). |
| ultrasound guided adductor canal block inserted before spinal anesthesia. | Active comparator | Procedure: bupivacaine and fentanylAs 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- .American Society of Anesthesiologists physical status (ASA) is I to III. .Both genders. .More than 40 years old.
Key exclusion criteria (1 listed)
- .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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bupivacaine and fentanylbupivacaine and fentanyl will be infused through the catheter | Procedure or surgery | epidural catheter inserted before spinal anesthesia., ultrasound guided adductor canal block inserted before spinal anesthesia., ultrasound guided femoral nerve catheter inserted before spinal anesthesia. |
Primary outcome
pain score
Time frame: 48 hours
Visual analogue score from 0 to 10
2 secondary outcomes
hemodynamic changes
Time frame: 48 hours
hemodynamic changes
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2022.
- Results publication: PubMed 31056239Chuan 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.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
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.