Pain After Extracorporeal Shock Wave LithotripsyNCT07316660
Palmitoylethanolamide vs Ibuprofen for Pain After ESWL
A study testing Palmitoylethanolamide (PEA) and Ibuprofen (Brufen®) in people with Pain After Extracorporeal Shock Wave Lithotripsy and Palmitoylethanolamide, run by Benha University at 1 site in Egypt.
Trial summary
Pain after extracorporeal shock wave lithotripsy (ESWL), a non-surgical procedure used to treat kidney stones, is common and is usually treated with non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain After Extracorporeal Shock Wave Lithotripsy, Palmitoylethanolamide
- What is being tested?
- Palmitoylethanolamide (PEA) and Ibuprofen (Brufen®)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Jul 2026
- 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
- Age 18-65 years
- ASA I or II
- Undergoing elective ESWL for renal or upper ureteric calculi
- Expected discharge same day or within 24 hours (outpatient ESWL).
- Able to provide informed consent and comply with study procedures (including diary/VAS recordings).
- Not currently taking chronic NSAIDs, opioids, or PEA supplements for ≥7 days prior to ESWL.
Who cannot join
- Chronic pain or daily analgesic use.
- Known allergy or contraindication to PEA, ibuprofen.
- Active peptic ulcer disease, known bleeding disorder, anticoagulant therapy
- Pregnancy or lactation.
- Use of steroids or other pain-modulating drugs.
- Severe renal impairment (eGFR <30 mL/min/1.73 m²).
- Hepatic failure or significant liver enzyme elevation (AST/ALT >3× ULN).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Palmitoylethanolamide Versus Ibuprofen for Acute Postoperative Pain After Extracorporeal Shock Wave Lithotripsy: A Randomized Trial
Pain after extracorporeal shock wave lithotripsy (ESWL), a non-surgical procedure used to treat kidney stones, is common and is usually treated with non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. However, NSAIDs may cause side effects in some patients, including stomach irritation and kidney problems.
Palmitoylethanolamide (PEA) is a naturally occurring substance in the body with anti-inflammatory and pain-relieving properties and has been shown to be safe in previous studies. This study aims to compare the effectiveness of PEA with ibuprofen for controlling acute postoperative pain after ESWL.
Read more
Participants undergoing ESWL will be randomly assigned to receive either oral PEA or oral ibuprofen. Pain intensity will be measured using a visual analogue scale during the first 24 hours after the procedure. The use of rescue pain medication and any side effects will also be recorded.
The results of this study may help determine whether PEA can be an effective alternative to ibuprofen for the management of acute pain after ESWL.
- Being tested
- Palmitoylethanolamide (PEA), Ibuprofen (Brufen®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palmitoylethanolamide (PEA)Drug
Palmitoylethanolamide (PEA) will be administered orally at a dose of 600 mg approximately 60 minutes before ESWL, followed by 600 mg every 8 hours for the first 24 hours after the procedure (total of three doses). PEA will be provided as a micronized or ultramicronized formulation. Participants will be allowed to receive rescue analgesia according to the study protocol if pain is not adequately controlled.
Ibuprofen (Brufen®)Drug
Ibuprofen will be administered orally at a dose of 400 mg approximately 60 minutes before ESWL, followed by 400 mg every 8 hours for the first 24 hours after the procedure (total of three doses), in accordance with standard clinical practice. Participants will be allowed to receive rescue analgesia according to the study protocol if pain is not adequately controlled.
| Study group | Role | What they receive |
|---|---|---|
| Palmitoylethanolamide Group | Experimental | Participants assigned to this arm will receive oral palmitoylethanolamide for management of acute postoperative pain following extracorporeal shock wave lithotripsy (ESWL). Rescue analgesia will be available if required. Receives: Drug: Palmitoylethanolamide (PEA) |
| Ibuprofen Group | Active comparator | Participants assigned to this arm will receive oral ibuprofen for management of acute postoperative pain following extracorporeal shock wave lithotripsy (ESWL). Rescue analgesia will be available if required. Receives: Drug: Ibuprofen (Brufen®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity measured by Visual Analogue Scale (VAS)
Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary comparison will be the VAS score measured 2 hours after extracorporeal shock wave lithotripsy (ESWL) between the palmitoylethanolamide and ibuprofen groups.
Measured: 2 hours after ESWL
Secondary outcomes (5)
Pain intensity over the first 24 hours after ESWL
Pain intensity will be assessed using the 10-cm visual analogue scale (VAS) at predefined time points after ESWL (e.g., recovery room, 30 minutes, 1 hour, 4 hours, 6 hours, 12 hours, and 24 hours) to evaluate pain progression over time.
Measured: From recovery room arrival up to 24 hours after ESWL
Time to first rescue analgesia
Time elapsed (in minutes) from completion of ESWL to the first administration of rescue analgesic medication for uncontrolled pain.
Measured: Up to 24 hours after ESWL
Total rescue analgesic consumption within 24 hours
Total amount of rescue analgesics administered within the first 24 hours after ESWL, recorded as grams of paracetamol and opioid consumption converted to morphine milligram equivalents (MME), if applicable.
Measured: Up to 24 hours after ESWL
Proportion of patients achieving clinically meaningful pain relief
The proportion of participants achieving at least a 30% and 50% reduction in pain intensity on the VAS compared with baseline or peak postoperative pain.
Measured: Within 24 hours after ESWL
Incidence of adverse events
The number and type of adverse events related to study medications, including gastrointestinal symptoms, renal-related symptoms, allergic reactions, or any other reported side effects.
Measured: From first dose of study medication up to 7 days after ESWL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Jan 2026
- Primary completion1 Jun 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain After Extracorporeal Shock Wave LithotripsyStudies of the same condition, open and under way.
- More trials run by Benha 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, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316660
- Sponsor's protocol ID
- RC.19.10.2025
- Status last verified
- Oct 2026
- First submitted
- 19 Dec 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Palmitoylethanolamide Versus Ibuprofen for Acute Postoperative Pain After Extracorporeal Shock Wave Lithotripsy: A Randomized Trial
- ClinicalTrials.gov ID
- NCT07316660
- Acronym / sponsor ID
- RC.19.10.2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 5 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.
Pain after extracorporeal shock wave lithotripsy (ESWL), a non-surgical procedure used to treat kidney stones, is common and is usually treated with non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. However, NSAIDs may cause side effects in some patients, including stomach irritation and kidney problems.
Palmitoylethanolamide (PEA) is a naturally occurring substance in the body with anti-inflammatory and pain-relieving properties and has been shown to be safe in previous studies. This study aims to compare the effectiveness of PEA with ibuprofen for controlling acute postoperative pain after ESWL.
Participants undergoing ESWL will be randomly assigned to receive either oral PEA or oral ibuprofen. Pain intensity will be measured using a visual analogue scale during the first 24 hours after the procedure. The use of rescue pain medication and any side effects will also be recorded.
The results of this study may help determine whether PEA can be an effective alternative to ibuprofen for the management of acute pain after ESWL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Palmitoylethanolamide Group | Experimental | Drug: Palmitoylethanolamide (PEA)Participants assigned to this arm will receive oral palmitoylethanolamide for management of acute postoperative pain following extracorporeal shock wave lithotripsy (ESWL). Rescue analgesia will be available if required. |
| Ibuprofen Group | Active comparator | Drug: Ibuprofen (Brufen®)Participants assigned to this arm will receive oral ibuprofen for management of acute postoperative pain following extracorporeal shock wave lithotripsy (ESWL). Rescue analgesia will be available if required. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-65 years
- ASA I or II
- Undergoing elective ESWL for renal or upper ureteric calculi
- Expected discharge same day or within 24 hours (outpatient ESWL).
- Able to provide informed consent and comply with study procedures (including diary/VAS recordings).
Key exclusion criteria (7 listed)
- Chronic pain or daily analgesic use.
- Known allergy or contraindication to PEA, ibuprofen.
- Active peptic ulcer disease, known bleeding disorder, anticoagulant therapy
- Pregnancy or lactation.
- Use of steroids or other pain-modulating drugs.
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 |
|---|---|---|
| Palmitoylethanolamide (PEA)Palmitoylethanolamide (PEA) will be administered orally at a dose of 600 mg approximately 60 minutes before ESWL, followed by 600 mg every 8 hours for the first 24 hours after the procedure (total of three doses). PEA will be provided as a micronized or ultramicronized formulation. Participants will be allowed to receive rescue analgesia according to the study protocol if pain is not adequately controlled. | Drug | Palmitoylethanolamide Group |
| Ibuprofen (Brufen®)Ibuprofen will be administered orally at a dose of 400 mg approximately 60 minutes before ESWL, followed by 400 mg every 8 hours for the first 24 hours after the procedure (total of three doses), in accordance with standard clinical practice. Participants will be allowed to receive rescue analgesia according to the study protocol if pain is not adequately controlled. | Drug | Ibuprofen Group |
Primary outcome
Postoperative pain intensity measured by Visual Analogue Scale (VAS)
Time frame: 2 hours after ESWL
Pain intensity will be assessed using a 10-cm visual analogue scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain. The primary comparison will be the VAS score measured 2 hours after extracorporeal shock wave lithotripsy (ESWL) between the palmitoylethanolamide and ibuprofen groups.
5 secondary outcomes
Pain intensity over the first 24 hours after ESWL
Time frame: From recovery room arrival up to 24 hours after ESWL
Time to first rescue analgesia
Time frame: Up to 24 hours after ESWL
Total rescue analgesic consumption within 24 hours
Time frame: Up to 24 hours after ESWL
Proportion of patients achieving clinically meaningful pain relief
Time frame: Within 24 hours after ESWL
Incidence of adverse events
Time frame: From first dose of study medication up to 7 days after ESWL
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 21 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Palmitoylethanolamide (PEA) and Ibuprofen (Brufen®) in people with Pain After Extracorporeal Shock Wave Lithotripsy and Palmitoylethanolamide, run by Benha 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 6 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 21 Oct 2026. 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?
Postoperative pain intensity measured by Visual Analogue Scale (VAS) (time frame: 2 hours after ESWL). 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 21 Oct 2026.