Pain After Knee ArthroplastyNCT07336901
Adductor Canal Block and IPACK Block vs Adductor Canal Block and the Gastrosoleus Interfascial Block After Total Knee Arthroplasty
A study testing Adductor Canal Block (ACB) + gastrosoleus interfascial plane block and Adductor Canal Block (ACB) + iPACK Block in people with Pain After Knee Arthroplasty, run by Fayoum University Hospital.
Trial summary
Evaluate analgesic efficacy of adductor canal block with IPACK versus that of adductor canal block with gastrosoleus interfascial plane block in total knee arthroplasty surgeries. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pain After Knee Arthroplasty
- What is being tested?
- Adductor Canal Block (ACB) + gastrosoleus interfascial plane block and Adductor Canal Block (ACB) + iPACK Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Feb 2026to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of ASA class I to III of both sexes
- undergoing unilateral total knee arthroplasty
- 40-80 years old
Who cannot join
- Patient refusal
- History of coagulopathies
- Severe renal insufficiency
- Preexisting lower limb neurological abnormality
- Known allergic history to any of the drugs used in this study
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Adductor Canal Block and IPACK Block Versus Adductor Canal Block and the Gastrosoleus Interfascial Plane Block for Postoperative Analgesia After Total Knee Arthroplasty: a Prospective Double Blinded Study
Evaluate analgesic efficacy of adductor canal block with IPACK versus that of adductor canal block with gastrosoleus interfascial plane block in total knee arthroplasty surgeries.
Read the detailed description
Total knee arthroplasty (TKA) is a surgical procedure commonly known for its association with sever postoperative pain. This pain can affect quality of recovery by restricting patient's ability to mobilize early and participate effectively in rehabilitation, which eventually will prolong hospital stays and increase healthcare costs. Also chronic postsurgical pain may complicate inadequately managed postsurgical pain.
Hence the need for exploring different analgesic modalities has evolved involving different techniques either regional anesthesia or systemic analgesics.
Peripheral nerve blockade was found to achieve adequate postoperative pain relief, and techniques such as sciatic nerve block, femoral nerve block and adductor canal block have been introduced.
Adductor canal block (ACB) has been shown to decrease pain significantly and thereby opioid consumption with minimal effect on quadriceps function.
Though ACB provides analgesia to the peripatellar and intra-articular aspect of knee joint, it does not relieve posterior knee pain which may compromise satisfactory pain relief.
Infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) by local anesthetics has been achieved by ultrasound and was found to provide significant posterior knee analgesia. Its technique was described by Elliott et al.
Recently the gastrosoleus interfascial plane block (GIP) was introduced in 2023 by Abraham et al which targets the fascial plane between the soleus muscle and the medial belly of the gastrocnemius muscle.
All patients will be preoperatively assessed then connected to basic monitors (ECG, NIBP and SpO2) IV line will be inserted and crystalloid fluid infusion will be started Patients will be premedicated by midazolam (1-2 mg), and they will be pre oxygenated 3-5 minutes before induction of anesthesia. General anesthesia will be given using propofol 2-3mg/kg intravenous (IV), fentanyl 1-2µg/kg IV and atracurium 0.5 mg/kg IV as a muscle relaxant to facilitate intubation. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Patients will be mechanically ventilated with 50% O2 and 50% air keeping end-tidal CO2 between 30 - 35 mmHg. Fentanyl bolus doses of 0.5-1 mcg/kg will be given according to the changes of hemodynamic variables (more than 20% base line).
Adductor canal block will be given to both groups. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.
The patients in group A will receive gastrosoleus interfascial plane block. The patients in Group B will receive IPACK with the patient placed in a supine position and knee placed in position of 90° flexion At PACU, all patients will receive paracetamol 1gm to be repeated every 8 hours.
Patients' pain will be assessed using VAS score (12) in the PACU and every 4 hours thereafter for two days. Patient with VAS score ≥4 will recieve a rescue dose of morphine 3-5 mg.
Vital signs including heart rate, systolic and diastolic BP, and oxygen saturation will be recorded intra operatively every 15 min and postoperatively every 4 hours while assessing pain intensity.
- Conditions
- Pain After Knee Arthroplasty
- Being tested
- Adductor Canal Block (ACB) + gastrosoleus interfascial plane block, Adductor Canal Block (ACB) + iPACK Block
- Keywords
- gastrosoleus interfascial plane block, knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor Canal Block (ACB) + gastrosoleus interfascial plane blockProcedure or surgery
Adductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.
The patients will receive gastrosoleus interfascial plane block. Using a linear probe the transducer will be placed along the medial border of the leg in long axis, 7 cm-8 cm below the popliteal crease. After identification of muscle bellies of the medial gastrocnemius head, the soleus and the trilaminar fascial plane between these muscles, 20 ml of bupivacaine 0.25% will be injected at this plane by piercing the fascia (loss of resistance).
Adductor Canal Block (ACB) + iPACK BlockProcedure or surgery
Adductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.
The patients will recieve IPACK with the patient placed in a supine position and knee placed in position of 90° flexion. By placing a low-frequency ultrasound probe in the popliteal crease the spinal needle will be advanced from medial aspect of the knee going from anteromedial to posterolateral between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| ACB/GIP group | Experimental | Adductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.
The gastrosoleus interfascial plane block will be given along the medial border of the leg in long axis, 7 cm-8 cm below the popliteal crease. After identification of muscle bellies of the medial gastrocnemius head, the soleus and the trilaminar fascial plane between these muscles, 20 ml of bupivacaine 0.25% will be injected at this plane by piercing the fascia. Receives: Procedure: Adductor Canal Block (ACB) + gastrosoleus interfascial plane block |
| ACB/IPACK group | Experimental | Adductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.
The patients will receive IPACK with the patient placed in a supine position and knee placed in position of 90° flexion. By placing a low-frequency ultrasound probe in the popliteal crease the spinal needle will be advanced from medial aspect of the knee going from anteromedial to posterolateral between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine will be injected. Receives: Procedure: Adductor Canal Block (ACB) + iPACK Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain using visual analogue score VAS score
- Postoperative pain using vas score where 0 is worst pain, 10 is no pain
Measured: change in VAS score 30 min after arrival to PACU change in VAS score 4 hours after arrival to PACU change in VAS score 8 hours after arrival to PACU change in VAS score 12 hours after arrival to PACU change in VAS score 24 hours after arrival to PACU
Secondary outcomes (6)
Time to first morphine analgesic dose and total rescue doses of morphine.
Time to first morphine analgesic dose in hours.
Measured: time needed for patient to use morphine in hours after end of surgery
cumulative doses of morphine
cumulative doses of morphine in mg
Measured: cumulative doses of morphine in mg in the first 24 hours after operation
Range of motion by assessing degree of knee extension 24 hours after surgery.
Range of motion by assessing degree of knee extension 24 hours after surgery.
Measured: Assessing degree of knee extension 24 hours after surgery.
Time of first postoperative ambulation and how many feets the patient will be able to walk.
Time of first postoperative ambulation and how many feets the patient will be able to walk.
Measured: Time of first postoperative ambulation and how many feets the patient will be able to walk in the 24 hours after operation
Duration of postoperative hospital stay.
Duration of postoperative hospital stay.
Measured: Duration of postoperative hospital stay in days
complications of the block
vascular injury, nerve injury, allergic reaction
Measured: complications of the block (vascular injury, nerve injury, allergic reaction) in the 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startFeb 2026 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain After Knee ArthroplastyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alyaa abdel sattar mohamed hassan, Fayoum University Hospital
- Investigators
- Alyaa A Hassan, lecturer, Principal investigator, Faculty of medicine, Fayoum universityMohamed A Shawky, Associate professor, Study director, Faculty of medicine, Fayoum universityOmar S Farghaly, Associate professor, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336901
- Sponsor's protocol ID
- R761
- Status last verified
- Dec 2025
- First submitted
- 26 Dec 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korean Knee Society. Guidelines for the management of postoperative pain after total knee arthroplasty. Knee Surg Relat Res. 2012 Dec;24(4):201-7. doi: 10.5792/ksrr.2012.24.4.201. Epub 2012 Nov 29.
PubMed 23269957Kim DH, Pearson-Chauhan KM, McCarthy RJ, Buvanendran A. Predictive Factors for Developing Chronic Pain After Total Knee Arthroplasty. J Arthroplasty. 2018 Nov;33(11):3372-3378. doi: 10.1016/j.arth.2018.07.028. Epub 2018 Aug 4.
PubMed 30143334
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Adductor Canal Block and IPACK Block Versus Adductor Canal Block and the Gastrosoleus Interfascial Plane Block for Postoperative Analgesia After Total Knee Arthroplasty: a Prospective Double Blinded Study
- ClinicalTrials.gov ID
- NCT07336901
- Acronym / sponsor ID
- R761
- Conditions
- Pain After Knee Arthroplasty
- Keywords
- gastrosoleus interfascial plane block, knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- Feb 2026 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 13 Jan 2026 (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.
Evaluate analgesic efficacy of adductor canal block with IPACK versus that of adductor canal block with gastrosoleus interfascial plane block in total knee arthroplasty surgeries.
Detailed description
Total knee arthroplasty (TKA) is a surgical procedure commonly known for its association with sever postoperative pain. This pain can affect quality of recovery by restricting patient's ability to mobilize early and participate effectively in rehabilitation, which eventually will prolong hospital stays and increase healthcare costs. Also chronic postsurgical pain may complicate inadequately managed postsurgical pain.
Hence the need for exploring different analgesic modalities has evolved involving different techniques either regional anesthesia or systemic analgesics.
Peripheral nerve blockade was found to achieve adequate postoperative pain relief, and techniques such as sciatic nerve block, femoral nerve block and adductor canal block have been introduced.
Adductor canal block (ACB) has been shown to decrease pain significantly and thereby opioid consumption with minimal effect on quadriceps function.
Though ACB provides analgesia to the peripatellar and intra-articular aspect of knee joint, it does not relieve posterior knee pain which may compromise satisfactory pain relief.
Infiltration of the interspace between popliteal artery and the capsule of posterior knee (IPACK) by local anesthetics has been achieved by ultrasound and was found to provide significant posterior knee analgesia. Its technique was described by Elliott et al.
Recently the gastrosoleus interfascial plane block (GIP) was introduced in 2023 by Abraham et al which targets the fascial plane between the soleus muscle and the medial belly of the gastrocnemius muscle.
All patients will be preoperatively assessed then connected to basic monitors (ECG, NIBP and SpO2) IV line will be inserted and crystalloid fluid infusion will be started Patients will be premedicated by midazolam (1-2 mg), and they will be pre oxygenated 3-5 minutes before induction of anesthesia. General anesthesia will be given using propofol 2-3mg/kg intravenous (IV), fentanyl 1-2µg/kg IV and atracurium 0.5 mg/kg IV as a muscle relaxant to facilitate intubation. Anesthesia will be maintained by isoflurane and atracurium 0.1-0.2 mg/kg every 20-30 minutes. Patients will be mechanically ventilated with 50% O2 and 50% air keeping end-tidal CO2 between 30 - 35 mmHg. Fentanyl bolus doses of 0.5-1 mcg/kg will be given according to the changes of hemodynamic variables (more than 20% base line).
Adductor canal block will be given to both groups. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected.
The patients in group A will receive gastrosoleus interfascial plane block. The patients in Group B will receive IPACK with the patient placed in a supine position and knee placed in position of 90° flexion At PACU, all patients will receive paracetamol 1gm to be repeated every 8 hours.
Patients' pain will be assessed using VAS score (12) in the PACU and every 4 hours thereafter for two days. Patient with VAS score ≥4 will recieve a rescue dose of morphine 3-5 mg.
Vital signs including heart rate, systolic and diastolic BP, and oxygen saturation will be recorded intra operatively every 15 min and postoperatively every 4 hours while assessing pain intensity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACB/GIP group | Experimental | Procedure: Adductor Canal Block (ACB) + gastrosoleus interfascial plane blockAdductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected. The gastrosoleus interfascial plane block will be given along the medial border of the leg in long axis, 7 cm-8 cm below the popliteal crease. After identification of muscle bellies of the medial gastrocnemius head, the soleus and the trilaminar fascial plane between these muscles, 20 ml of bupivacaine 0.25% will be injected at this plane by piercing the fascia. |
| ACB/IPACK group | Experimental | Procedure: Adductor Canal Block (ACB) + iPACK BlockAdductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected. The patients will receive IPACK with the patient placed in a supine position and knee placed in position of 90° flexion. By placing a low-frequency ultrasound probe in the popliteal crease the spinal needle will be advanced from medial aspect of the knee going from anteromedial to posterolateral between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine will be injected. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of ASA class I to III of both sexes
- undergoing unilateral total knee arthroplasty
- 40-80 years old
Key exclusion criteria (5 listed)
- Patient refusal
- History of coagulopathies
- Severe renal insufficiency
- Preexisting lower limb neurological abnormality
- Known allergic history to any of the drugs used in this study
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 |
|---|---|---|
| Adductor Canal Block (ACB) + gastrosoleus interfascial plane blockAdductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected. The patients will receive gastrosoleus interfascial plane block. Using a linear probe the transducer will be placed along the medial border of the leg in long axis, 7 cm-8 cm below the popliteal crease. After identification of muscle bellies of the medial gastrocnemius head, the soleus and the trilaminar fascial plane between these muscles, 20 ml of bupivacaine 0.25% will be injected at this plane by piercing the fascia (loss of resistance). | Procedure or surgery | ACB/GIP group |
| Adductor Canal Block (ACB) + iPACK BlockAdductor canal block will be given. In supine position, the leg will be externally rotated and the probe will be positioned at the midpoint of the thigh on its medial aspect. The adductor canal (AC) will be located anterolaterally to the superficial femoral artery deep to the sartorius muscle. The needle (size) will be advanced and a particular "pop" will be felt when the tip pierced the vastoadductor membrane, which is the roof of the adductor canal. A single dose of (20 ml of 0.25% bupivacaine) will be injected. The patients will recieve IPACK with the patient placed in a supine position and knee placed in position of 90° flexion. By placing a low-frequency ultrasound probe in the popliteal crease the spinal needle will be advanced from medial aspect of the knee going from anteromedial to posterolateral between the popliteal artery and the femur. The tip of the needle will be placed 1-2 cm beyond the lateral edge of the artery, and 20 ml of 0.25% bupivacaine will be injected. | Procedure or surgery | ACB/IPACK group |
Primary outcome
Postoperative pain using visual analogue score VAS score
Time frame: change in VAS score 30 min after arrival to PACU change in VAS score 4 hours after arrival to PACU change in VAS score 8 hours after arrival to PACU change in VAS score 12 hours after arrival to PACU change in VAS score 24 hours after arrival to PACU
• Postoperative pain using vas score where 0 is worst pain, 10 is no pain
6 secondary outcomes
Time to first morphine analgesic dose and total rescue doses of morphine.
Time frame: time needed for patient to use morphine in hours after end of surgery
cumulative doses of morphine
Time frame: cumulative doses of morphine in mg in the first 24 hours after operation
Range of motion by assessing degree of knee extension 24 hours after surgery.
Time frame: Assessing degree of knee extension 24 hours after surgery.
Time of first postoperative ambulation and how many feets the patient will be able to walk.
Time frame: Time of first postoperative ambulation and how many feets the patient will be able to walk in the 24 hours after operation
Duration of postoperative hospital stay.
Time frame: Duration of postoperative hospital stay in days
complications of the block
Time frame: complications of the block (vascular injury, nerve injury, allergic reaction) in the 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Background: PubMed 23269957Korean Knee Society. Guidelines for the management of postoperative pain after total knee arthroplasty. Knee Surg Relat Res. 2012 Dec;24(4):201-7. doi: 10.5792/ksrr.2012.24.4.201. Epub 2012 Nov 29.
- Background: PubMed 30143334Kim DH, Pearson-Chauhan KM, McCarthy RJ, Buvanendran A. Predictive Factors for Developing Chronic Pain After Total Knee Arthroplasty. J Arthroplasty. 2018 Nov;33(11):3372-3378. doi: 10.1016/j.arth.2018.07.028. Epub 2018 Aug 4.
- 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.
Alyaa A Hassan, lecturer principal investigator
Faculty of medicine, Fayoum university
Mohamed A Shawky, Associate professor study director
Faculty of medicine, Fayoum university
Omar S Farghaly, Associate professor principal investigator
Faculty of medicine, Fayoum university
Questions about this trial
What is this clinical trial studying?
A study testing Adductor Canal Block (ACB) + gastrosoleus interfascial plane block and Adductor Canal Block (ACB) + iPACK Block in people with Pain After Knee Arthroplasty, run by Fayoum University Hospital.
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 3 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alyaa A Hassan, lecturer (01091169956 +2, aam17@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain using visual analogue score VAS score (time frame: change in VAS score 30 min after arrival to PACU change in VAS score 4 hours after arrival to PACU change in VAS score 8 hours after arrival to PACU change in VAS score 12 hours after arrival to PACU change in VAS score 24 hours after arrival to PACU). 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 NCT07336901, which also lists 2 linked publications.
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 13 Jan 2026.