Pain, PostoperativeNCT05438992
Different Bupivacaine Volumes in Infiltration Between Popliteal Artery and Capsule of Knee Block
A study testing Bupivacaine 0.25% Preservative-Free Injectable Solution in people with Pain, Postoperative, run by Cairo University at 1 site in Egypt.
Trial summary
comparing between three different volumes; 15, 20 \& 25 ml of 0.25% bupivacaine to determine the best volume of Infiltration Between Popliteal Artery and Capsule of Knee (IPACK) block following adductor canal block (ACB) with the best analgesia and least complications after total knee arthroplasty (TKA) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine 0.25% Preservative-Free Injectable Solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2023to 20 Apr 2024
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing knee arthroscopy surgery.
- Age between 18 years and 65 years.
- Both sexes
- ASA I \& ASA II
Who cannot join
- Patients' refusal
- Allergy to any drug that will be used in the study
- Psychological or mental disorders.
- Disturbance of Conscious level.
- Uncooperative patients
- Coagulopathy
- Contraindications to spinal anaesthesia (e.g.: severe mitral stenosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing the Effect of Three Different Volumes of Bupivacaine in Infiltration Between Popliteal Artery and Capsule of Knee Block Following Adductor Canal Block in Total Knee Arthroplasty, Prospective Randomized Control Trial.
comparing between three different volumes; 15, 20 \& 25 ml of 0.25% bupivacaine to determine the best volume of Infiltration Between Popliteal Artery and Capsule of Knee (IPACK) block following adductor canal block (ACB) with the best analgesia and least complications after total knee arthroplasty (TKA)
Read the detailed description
105 participants will be randomized into three groups based on computer generated numbers using online randomization program
Preoperative assessment is conducted on the patients that will be enrolled in this study including history taking, physical examination, and routine laboratory investigations; in the form of CBC, coagulation profile, creatinine, urea, ALT, AST and radiological investigations; according to the medical condition of the patients. All patients should fulfill the inclusion criteria.
a written informed consent form will be obtained from the patients that will be enrolled in the study.
Preoperative:
On the day of surgery, the patient ID will be confirmed in the preparation room, then 18 G cannula will be inserted to the patient, premedication will be given including lactated ringer solution 500 ml, midazolam 2 mg \& metoclopramide 10 mg.
VAS scale. Visual analogue scale (VAS) for measuring post-operative pain will be explained to all patients. VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end. It has two ends one end was labelled as no pain (0) and the other end was labelled as worst pain (10)".
The patient marks on the line the point that they feel represents their perception of their current state.
Intraoperative:
The patients enrolled in the study will be transferred to the Operation room and monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure and ECG.
To perform spinal anesthesia ,the patient will be positioned in the sitting position then sterilization of the back using betadine solution 5% will be done then the iliac crest will be identified and the opposite intervertebral space(L4-L5) will be marked then 5 ml of lidocaine 2% will be infiltrated in the skin and subcutaneous tissue then a spinal needle (22 G )or(25 G) will be introduced to the intrathecal space and after ensuring that clear cerebrospinal fluid will be in free flow injection of 15 - 20 mg of bupivacaine 0.5 % and 25 mcg of fentanyl will be administrated then the patient will be positioned in the supine position.
If hypotension, (decrease in the mean arterial blood pressure of more than 20%from base line) occurs, 3mg ephedrine will be given with 200ml bolus crystalloids. If bradycardia (heart rate below 50 beat / minute) occurs, 0.5 mg intravenous atropine will be given.
At the end of the operation, patients will be randomly allocated using computerized generated random tables in to three equal groups and the random numbers will be concealed in closed opaque envelopes which will be kept by the senior anesthesia staff, the three groups are:
Group A: The patients in this group will be administered 15 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
Group B: The patients in this group will be administered 20 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
Group C: The patients in this group will be administered 25 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
With the patient in the supine position, adductor canal block will be performed, the procedural needle will be inserted in-plane from the anteromedial side at the mid-thigh level. It will be advanced through the sartorius muscle and fascia under ultrasound guidance, using a Siemens Acuson X300 ultrasound equipped with a linear transducer after sterilization of the skin with betadine solution 5%, and the adductor canal, with the superficial femoral artery and vein within, will be identified. Once the needle ( spinal needle 22g) tip will be located in the adductor canal, 20 ml bupivacaine 0.25% will be injected anterior to the artery and deep into the sartorius muscle.
.
Then, IPACK block will be performed by scanning the popliteal fossa under ultrasound guidance, the transducer will be slowly moved toward the popliteal crease until the tibial nerve will be identified superficial to the popliteal vessels. The femoral condyles will be defined at this level. The needle will be advanced in a medial- to- lateral direction using an in plane approach and advanced to the intercondylar fossa between the popliteal artery and the femoral condyles. When the needle tip will be located anteriorly to the lateral edge of the popliteal artery, the volume of bupivacaine 0.250% according to each group will be injected using spinal needle 22 gauge while slowly withdrawing the needle until the tip of the needle reached the medial femoral condyle. After that patient will be transferred to the recovery room then to the ward.
Patient should be will monitored during injection of local anesthetic to detect local anesthetic toxicity which usually begins within 1-5 min and may delay up to 1 hr with prodromal signs, as perioral numbness, tinnitus, agitation, dysarthria, and confusion. Then severe central nervous system (CNS) symptoms such as seizures and coma. Also, cardiovascular( CV) symptoms presenting initially with hypertension and tachycardia, then bradycardia and hypotension, with progression to more serious complications, including ventricular arrhythmias and asystole. The patient can manifest as isolated CV dysfunction or as a combination of CNS and CV signs without the classical progression.
Risk of toxicity increases with the type of local anesthetic and dose, site of injection, extremes of age and patient's comorbidities as organ dysfunction, Preexisting cardiac disease which increase risk of arrhythmias and myocardial depression and the serum level of the binding proteins.
So caution is advised in patient with decompensated heart failure, severe valvular disease, or depressed ventricular function. Also, Patients with renal or hepatic failure can result in decreased metabolism and clearance and a higher level of circulating drug. In addition, malnutrition, or any other disease process that results in a decreased serum level of albumin can increase the level of the free drug for a given dose.
Postoperative:
- Postoperative pain will be assessed by visual analog scale (VAS) at times 0-30 minutes, 1, 2, 4, , 8, 12, 18 and 24 hours postoperatively.
- Postoperative pain assessment through VAS will be according to the scale as follow:
- Pain level 0: no pain
- Pain level1-3: mild pain
- Pain level 4-6: moderate pain
- Pain level 7-10: severe pain
- Postoperative pain will be managed as follow:
- Mild pain will be treated with paracetamol 1 gm iv.
- Moderate pain will be treated with paracetamol 1 gm iv \& ketolac, 30 mg iv.
- Severe pain will be treated with paracetamol 1 gm iv , ketolac, 30 mg iv \& morphine 0.1 mg/kg iv (rescue analgesia) Then patient will be reassessed and recorded as mentioned above and the specific treatment will be repeated after 8 hours from the initial dose according to VAS.
- Opioids complications such as respiratory depression will be recorded and managed supportively by oxygen mask, controlled airway and if persistent or severe hypoventilation occurs positive pressure ventilation may be needed, nausea and vomiting will be treated with ondansetron (4 mg IV).
- Criteria of failed block : persistent sever pain after elimination of spinal anesthesia vas score >6 and need more doses of opioids
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine 0.25% Preservative-Free Injectable Solution
- 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 0.25% Preservative-Free Injectable SolutionDrug
local anesthetic drug injection for postoperative pain
| Study group | Role | What they receive |
|---|---|---|
| group A | Active comparator | The patients in this group will be administered 15 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee. Receives: Drug: Bupivacaine 0.25% Preservative-Free Injectable Solution |
| Group B | Active comparator | The patients in this group will be administered 20 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee. Receives: Drug: Bupivacaine 0.25% Preservative-Free Injectable Solution |
| Group C | Active comparator | The patients in this group will be administered 25 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee. Receives: Drug: Bupivacaine 0.25% Preservative-Free Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score ( VAS) for 24 hours postoperatively
assessment of pain score
Measured: 24 hours
Secondary outcomes (5)
first rescue analgesia time
Time (in hours) of first rescue analgesia (morphine 0.1mg/kg) requirement for each group following the IPACK block
Measured: 24 hours
morphine consumption
Total amount of morphine/kg consumed in the first 24 hours following the IPACK block ( Max dose 0.4mg/kg/24hrs).
Measured: 24 hours
sensory block
duration of sensory block through 24hrs using test ice.
Measured: 24 hours
morphine complications
nausea and vomiting, bradycardia, respiratory depression
Measured: 24 hours
postoperative hemodynamics
postoperative hemodynamics including heart rate, blood pressure at times 0-30 minutes, 1, 2, 4, , 8, 12, 18 and 24 hours postoperatively
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start15 Dec 2023
- Primary completion31 Mar 2024
- Study completion20 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba Omar Ahmed, Cairo University
- Investigators
- Heba Omar, MD, Principal investigator, associate professor of anesthesia and surgical ICU, faculty of medicine, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438992
- Sponsor's protocol ID
- MD-339-2021
- Status last verified
- Apr 2024
- First submitted
- 25 Jun 2022
- Last updated
- 29 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Effect of Three Different Volumes of Bupivacaine in Infiltration Between Popliteal Artery and Capsule of Knee Block Following Adductor Canal Block in Total Knee Arthroplasty, Prospective Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05438992
- Acronym / sponsor ID
- MD-339-2021
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 20 Apr 2024 (actual)
- First posted
- 30 Jun 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.
comparing between three different volumes; 15, 20 \& 25 ml of 0.25% bupivacaine to determine the best volume of Infiltration Between Popliteal Artery and Capsule of Knee (IPACK) block following adductor canal block (ACB) with the best analgesia and least complications after total knee arthroplasty (TKA)
Detailed description
105 participants will be randomized into three groups based on computer generated numbers using online randomization program
Preoperative assessment is conducted on the patients that will be enrolled in this study including history taking, physical examination, and routine laboratory investigations; in the form of CBC, coagulation profile, creatinine, urea, ALT, AST and radiological investigations; according to the medical condition of the patients. All patients should fulfill the inclusion criteria.
a written informed consent form will be obtained from the patients that will be enrolled in the study.
Preoperative:
On the day of surgery, the patient ID will be confirmed in the preparation room, then 18 G cannula will be inserted to the patient, premedication will be given including lactated ringer solution 500 ml, midazolam 2 mg \& metoclopramide 10 mg.
VAS scale. Visual analogue scale (VAS) for measuring post-operative pain will be explained to all patients. VAS is a horizontal line, 100 mm in length, anchored by word descriptors at each end. It has two ends one end was labelled as no pain (0) and the other end was labelled as worst pain (10)".
The patient marks on the line the point that they feel represents their perception of their current state.
Intraoperative:
The patients enrolled in the study will be transferred to the Operation room and monitored all through the surgical procedure using pulse oximeter, non-invasive blood pressure and ECG.
To perform spinal anesthesia ,the patient will be positioned in the sitting position then sterilization of the back using betadine solution 5% will be done then the iliac crest will be identified and the opposite intervertebral space(L4-L5) will be marked then 5 ml of lidocaine 2% will be infiltrated in the skin and subcutaneous tissue then a spinal needle (22 G )or(25 G) will be introduced to the intrathecal space and after ensuring that clear cerebrospinal fluid will be in free flow injection of 15 - 20 mg of bupivacaine 0.5 % and 25 mcg of fentanyl will be administrated then the patient will be positioned in the supine position.
If hypotension, (decrease in the mean arterial blood pressure of more than 20%from base line) occurs, 3mg ephedrine will be given with 200ml bolus crystalloids. If bradycardia (heart rate below 50 beat / minute) occurs, 0.5 mg intravenous atropine will be given.
At the end of the operation, patients will be randomly allocated using computerized generated random tables in to three equal groups and the random numbers will be concealed in closed opaque envelopes which will be kept by the senior anesthesia staff, the three groups are:
Group A: The patients in this group will be administered 15 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
Group B: The patients in this group will be administered 20 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
Group C: The patients in this group will be administered 25 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee.
With the patient in the supine position, adductor canal block will be performed, the procedural needle will be inserted in-plane from the anteromedial side at the mid-thigh level. It will be advanced through the sartorius muscle and fascia under ultrasound guidance, using a Siemens Acuson X300 ultrasound equipped with a linear transducer after sterilization of the skin with betadine solution 5%, and the adductor canal, with the superficial femoral artery and vein within, will be identified. Once the needle ( spinal needle 22g) tip will be located in the adductor canal, 20 ml bupivacaine 0.25% will be injected anterior to the artery and deep into the sartorius muscle.
.
Then, IPACK block will be performed by scanning the popliteal fossa under ultrasound guidance, the transducer will be slowly moved toward the popliteal crease until the tibial nerve will be identified superficial to the popliteal vessels. The femoral condyles will be defined at this level. The needle will be advanced in a medial- to- lateral direction using an in plane approach and advanced to the intercondylar fossa between the popliteal artery and the femoral condyles. When the needle tip will be located anteriorly to the lateral edge of the popliteal artery, the volume of bupivacaine 0.250% according to each group will be injected using spinal needle 22 gauge while slowly withdrawing the needle until the tip of the needle reached the medial femoral condyle. After that patient will be transferred to the recovery room then to the ward.
Patient should be will monitored during injection of local anesthetic to detect local anesthetic toxicity which usually begins within 1-5 min and may delay up to 1 hr with prodromal signs, as perioral numbness, tinnitus, agitation, dysarthria, and confusion. Then severe central nervous system (CNS) symptoms such as seizures and coma. Also, cardiovascular( CV) symptoms presenting initially with hypertension and tachycardia, then bradycardia and hypotension, with progression to more serious complications, including ventricular arrhythmias and asystole. The patient can manifest as isolated CV dysfunction or as a combination of CNS and CV signs without the classical progression.
Risk of toxicity increases with the type of local anesthetic and dose, site of injection, extremes of age and patient's comorbidities as organ dysfunction, Preexisting cardiac disease which increase risk of arrhythmias and myocardial depression and the serum level of the binding proteins.
So caution is advised in patient with decompensated heart failure, severe valvular disease, or depressed ventricular function. Also, Patients with renal or hepatic failure can result in decreased metabolism and clearance and a higher level of circulating drug. In addition, malnutrition, or any other disease process that results in a decreased serum level of albumin can increase the level of the free drug for a given dose.
Postoperative:
- Postoperative pain will be assessed by visual analog scale (VAS) at times 0-30 minutes, 1, 2, 4, , 8, 12, 18 and 24 hours postoperatively.
- Postoperative pain assessment through VAS will be according to the scale as follow:
- Pain level 0: no pain
- Pain level1-3: mild pain
- Pain level 4-6: moderate pain
- Pain level 7-10: severe pain
- Postoperative pain will be managed as follow:
- Mild pain will be treated with paracetamol 1 gm iv.
- Moderate pain will be treated with paracetamol 1 gm iv \& ketolac, 30 mg iv.
- Severe pain will be treated with paracetamol 1 gm iv , ketolac, 30 mg iv \& morphine 0.1 mg/kg iv (rescue analgesia) Then patient will be reassessed and recorded as mentioned above and the specific treatment will be repeated after 8 hours from the initial dose according to VAS.
- Opioids complications such as respiratory depression will be recorded and managed supportively by oxygen mask, controlled airway and if persistent or severe hypoventilation occurs positive pressure ventilation may be needed, nausea and vomiting will be treated with ondansetron (4 mg IV).
- Criteria of failed block : persistent sever pain after elimination of spinal anesthesia vas score >6 and need more doses of opioids
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group A | Active comparator | Drug: Bupivacaine 0.25% Preservative-Free Injectable SolutionThe patients in this group will be administered 15 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee. |
| Group B | Active comparator | Drug: Bupivacaine 0.25% Preservative-Free Injectable SolutionThe patients in this group will be administered 20 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee. |
| Group C | Active comparator | Drug: Bupivacaine 0.25% Preservative-Free Injectable SolutionThe patients in this group will be administered 25 ml bupivacaine 0.250 % between the popliteal artery and the capsule of the posterior knee. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients undergoing knee arthroscopy surgery.
- Age between 18 years and 65 years.
- Both sexes
- ASA I \& ASA II
Key exclusion criteria (7 listed)
- Patients' refusal
- Allergy to any drug that will be used in the study
- Psychological or mental disorders.
- Disturbance of Conscious level.
- Uncooperative patients
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 0.25% Preservative-Free Injectable Solutionlocal anesthetic drug injection for postoperative pain | Drug | Group B, Group C, group A |
Primary outcome
visual analogue score ( VAS) for 24 hours postoperatively
Time frame: 24 hours
assessment of pain score
5 secondary outcomes
first rescue analgesia time
Time frame: 24 hours
morphine consumption
Time frame: 24 hours
sensory block
Time frame: 24 hours
morphine complications
Time frame: 24 hours
postoperative hemodynamics
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Heba Omar, MD principal investigator
associate professor of anesthesia and surgical ICU, faculty of medicine, Cairo university
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 0.25% Preservative-Free Injectable Solution in people with Pain, Postoperative, run by Cairo 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 29 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue score ( VAS) for 24 hours postoperatively (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2024.