Loxoprofen Sodium PatchNCT07591207
The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Laparoscopic Surgery
A study testing Loxoprofen Sodium Patch on the contralateral side and Loxoprofen Sodium Patch on the incision site in people with Loxoprofen Sodium Patch and Local Incision, run by Beijing Tiantan Hospital at 2 sites in China.
Trial summary
Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Loxoprofen Sodium Patch, Local Incision, Laparoscopic Cholecystectomy
- What is being tested?
- Loxoprofen Sodium Patch on the contralateral side and Loxoprofen Sodium Patch on the incision site
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jun 2026to 31 May 2028
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients scheduled for elective Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair under general anesthesia;
- Ages 18 to 64 years old
- American Society of Anesthesiologists (ASA) physical status of I-III
- Patients must be able to understand the nature and potential personal consequences of the clinical trial and cooperate with follow-up investigations
- signing of the informed consent form.
Who cannot join
- History of chronic pain syndrome of any cause and mental illness
- Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery.
- History of hypertension (Grade 3, extremely high risk)
- Pregnancy or breastfeeding.
- Extreme body mass index (BMI) (< 15 or > 35).
- Participation in another interventional trial that interferes with the intervention or outcome of this trial.
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- Digestive system diseases (such as peptic ulcers, gastric bleeding).
- Patients with coronary artery disease.
- Patients with renal impairment (serum creatinine > 176 µmol/L) and abnormal liver function(alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 2× the upper limit of normal (ULN) or total bilirubin (TBIL) ≥ 1.5×ULN).
- Subjects with coagulation dysfunction (prothrombin time or activated partial thromboplastin time is higher than the normal threshold) or patients who are taking oral anticoagulants for other medical reasons and have not stopped it before surgery, such as warfarin or new anticoagulants rivaroxaban or dabigatran.
- Patients with a history of allergy to anyone of the study drugs.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Fang Luo, +86 13611326978, 13611326978@163.com
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality, 100070
Fang Luo, +86 13611326978, 13611326978@163.com
About this study
Official title: The Efficacy and Safety of Incisional Preemptive Analgesia Using Loxoprofen Sodium Patch in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.
Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization.
The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore the use of Loxoprofen Sodium Patch for preoperative local incision analgesia in laparoscopic surgery patients. The investigators aim to observe whether this method can effectively alleviate postoperative incision pain, reduce the dosage of postoperative analgesics and the side effects caused using postoperative analgesics, improve patient satisfaction, and provide new ideas for postoperative analgesia in laparoscopic surgery patients, promoting rapid recovery after laparoscopic surgery.
- Conditions
- Loxoprofen Sodium Patch, Local Incision, Laparoscopic Cholecystectomy, Appendectomy, Laparoscopic, Hernia Repair
- Being tested
- Loxoprofen Sodium Patch on the contralateral side, Loxoprofen Sodium Patch on the incision site
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loxoprofen Sodium Patch on the contralateral sideDrug
Also called Active Comparator
Apply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing laparoscopic surgery 12 hours before surgery.
Loxoprofen Sodium Patch on the incision siteDrug
Apply Loxoprofen Sodium Patch on the incision site of patients undergoing laparoscopic surgery 12 hours before surgery
| Study group | Role | What they receive |
|---|---|---|
| On the contralateral side | Active comparator | We apply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing laparoscopic surgery 12 hours before surgery. Receives: Drug: Loxoprofen Sodium Patch on the contralateral side |
| On the incision site | Experimental | Apply Loxoprofen Sodium Patch to the incision site of patients undergoing laparoscopic surgery 12 hours before surgery Receives: Drug: Loxoprofen Sodium Patch on the incision site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Measured: The postoperative period 48 hours
Secondary outcomes (8)
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain
Measured: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain, scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Measured: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively
The Numeric Rating Scale (NRS) designates 0 as representing no pain and 10 as representing the most severe pain; scores of 1-3 indicate mild pain, 4-6 denote moderate pain, and 7-10 signify severe pain.
Measured: Postoperative day 7, month 1, and month 3.
Patient Satisfaction Scale(PSS)
Patient Satisfaction Scale(PSS) on a scale ranging from 0 to 10, where 0 denotes "completely dissatisfied" and 10 signifies "extremely satisfied."
Measured: Postoperative hours 4、12、24 and 48 hours
Postoperative nausea and vomiting(PONV)
Measured: Postoperatively within 48 hours
wound healing score
The wound healing score is evaluated by independent researchers based on the wound healing score table, which includes three aspects: skin healing, incision infection, and hair growth. The total score is obtained by adding up the three scores. Excellent wound healing: 3 points; Good wound healing is 4-5; Poor wound healing: total score greater than or equal to 6 points.
Measured: Postoperative 72hours、1 and 3 months.
postoperatively and patient and observer scar assessment scale
Postoperatively and patient and observer scar assessment scale: the observer scores the scar based on the distribution of blood vessels around the incision, color, scar thickness, surface roughness, area, and softness. Each score ranges from 1 to 10 points and higher scores indicating more severe scars; The patient evaluates the scar based on whether there is pain or itching, color, softness, thickness, and self-perception. Each score range is also 1-10 points, with 1 point indicating no difference from normal skin and a higher score indicating more severe scars.
Measured: Postoperative 72 hours、1 and 3 months
Adverse events
Such as itching, erythema, contact dermatitis, discomfort in the stomach, elevated ALT (GPT) and elevated AST (GOT)
Measured: Within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2026
- Study start1 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Loxoprofen Sodium PatchStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Luo, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591207
- Sponsor's protocol ID
- KY2025-338-02-1
- Status last verified
- Jun 2026
- First submitted
- 9 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Fujiki EN, Netto NA, Kraychete DC, Daher MT, Tardini R, Nakamoto A, Lopes DG. Efficacy and safety of loxoprofen sodium topical patch for the treatment of pain in patients with minor acute traumatic limb injuries in Brazil: a randomized, double-blind, noninferiority trial. Pain. 2019 Jul;160(7):1606-1613. doi: 10.1097/j.pain.0000000000001549.
PubMed 30839430Lee IO, Kim SH, Kong MH, Lee MK, Kim NS, Choi YS, Lim SH. Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Can J Anaesth. 2001 Jun;48(6):545-50. doi: 10.1007/BF03016830.
PubMed 11444448Bisgaard T, Klarskov B, Kristiansen VB, Callesen T, Schulze S, Kehlet H, Rosenberg J. Multi-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blinded, placebo-controlled study. Anesth Analg. 1999 Oct;89(4):1017-24. doi: 10.1097/00000539-199910000-00036.
PubMed 10512282
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Incisional Preemptive Analgesia Using Loxoprofen Sodium Patch in Patients Undergoing Laparoscopic Surgery: a Multi-center Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07591207
- Acronym / sponsor ID
- KY2025-338-02-1
- Conditions
- Loxoprofen Sodium Patch, Local Incision, Laparoscopic Cholecystectomy, Appendectomy, Laparoscopic, Hernia Repair
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 15 May 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.
Studies have shown that up to 80% of patients experience postoperative pain following laparoscopic surgery due to inflammation caused by surgical incisions and surrounding tissues, necessitating pharmacological relief. Inflammatory mediators released from the soft tissues around laparoscopic incisions not only significantly alters the chemical microenvironment at the peripheral terminals of nociceptors, directly inducing pain, but also sensitizes afferent fibers, contributing to peripheral sensitization.
The investigators conducted a multicenter, prospective, randomized controlled clinical study to explore the use of Loxoprofen Sodium Patch for preoperative local incision analgesia in laparoscopic surgery patients. The investigators aim to observe whether this method can effectively alleviate postoperative incision pain, reduce the dosage of postoperative analgesics and the side effects caused using postoperative analgesics, improve patient satisfaction, and provide new ideas for postoperative analgesia in laparoscopic surgery patients, promoting rapid recovery after laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On the contralateral side | Active comparator | Drug: Loxoprofen Sodium Patch on the contralateral sideWe apply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing laparoscopic surgery 12 hours before surgery. |
| On the incision site | Experimental | Drug: Loxoprofen Sodium Patch on the incision siteApply Loxoprofen Sodium Patch to the incision site of patients undergoing laparoscopic surgery 12 hours before surgery |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective Laparoscopic Surgery for laparoscopic cholecystectomy, appendectomy, or hernia repair under general anesthesia;
- Ages 18 to 64 years old
- American Society of Anesthesiologists (ASA) physical status of I-III
- Patients must be able to understand the nature and potential personal consequences of the clinical trial and cooperate with follow-up investigations
- signing of the informed consent form.
Key exclusion criteria (11 listed)
- History of chronic pain syndrome of any cause and mental illness
- Excessive alcohol or drug abuse, chronic opioid use (more than 2 weeks or 3 days per week for more than 1 month), use of drugs with confirmed or suspected sedative or analgesic effects, or use of any painkiller within 24 h before surgery.
- History of hypertension (Grade 3, extremely high risk)
- Pregnancy or breastfeeding.
- Extreme body mass index (BMI) (< 15 or > 35).
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 |
|---|---|---|
| Loxoprofen Sodium Patch on the contralateral sideAlso: Active ComparatorApply Loxoprofen Sodium Patch on the contralateral side of the incision in patients undergoing laparoscopic surgery 12 hours before surgery. | Drug | On the contralateral side |
| Loxoprofen Sodium Patch on the incision siteApply Loxoprofen Sodium Patch on the incision site of patients undergoing laparoscopic surgery 12 hours before surgery | Drug | On the incision site |
Primary outcome
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively
Time frame: The postoperative period 48 hours
8 secondary outcomes
Area Under the Curve (AUC) of Numeric Rating Scale at rest (NRSr) Within 0-72 Hours Postoperatively
Time frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Area under the curve (AUC) of the Numerical Rating Scale during movement (NRSm) within 0-72 hours postoperatively
Time frame: Data will be collected at 4、12、24、36 and 72 hours postoperatively
Numeric Rating Scale at rest (NRSr) at 1 week, 1 month, and 3 months postoperatively
Time frame: Postoperative day 7, month 1, and month 3.
Patient Satisfaction Scale(PSS)
Time frame: Postoperative hours 4、12、24 and 48 hours
Postoperative nausea and vomiting(PONV)
Time frame: Postoperatively within 48 hours
wound healing score
Time frame: Postoperative 72hours、1 and 3 months.
postoperatively and patient and observer scar assessment scale
Time frame: Postoperative 72 hours、1 and 3 months
Adverse events
Time frame: Within 72 hours postoperatively
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 16 Jun 2026.
- Results publication: PubMed 30839430Fujiki EN, Netto NA, Kraychete DC, Daher MT, Tardini R, Nakamoto A, Lopes DG. Efficacy and safety of loxoprofen sodium topical patch for the treatment of pain in patients with minor acute traumatic limb injuries in Brazil: a randomized, double-blind, noninferiority trial. Pain. 2019 Jul;160(7):1606-1613. doi: 10.1097/j.pain.0000000000001549.
- Results publication: PubMed 11444448Lee IO, Kim SH, Kong MH, Lee MK, Kim NS, Choi YS, Lim SH. Pain after laparoscopic cholecystectomy: the effect and timing of incisional and intraperitoneal bupivacaine. Can J Anaesth. 2001 Jun;48(6):545-50. doi: 10.1007/BF03016830.
- Results publication: PubMed 10512282Bisgaard T, Klarskov B, Kristiansen VB, Callesen T, Schulze S, Kehlet H, Rosenberg J. Multi-regional local anesthetic infiltration during laparoscopic cholecystectomy in patients receiving prophylactic multi-modal analgesia: a randomized, double-blinded, placebo-controlled study. Anesth Analg. 1999 Oct;89(4):1017-24. doi: 10.1097/00000539-199910000-00036.
- Individual participant dataSharing planned: Yes
Related trials for Loxoprofen Sodium Patch
Not yet recruiting
The Efficacy and Safety of Loxoprofen Sodium Patch in Relieving Postoperative Pain After Thoracoscopic Surgery
Video-assisted Thoracoscopic Surgery (VATS), Loxoprofen Sodium Patch
Recruiting
The Analgesic Efficacy and Safety of Loxoprofen Sodium Patch in Patients With Herpes Zoster
Herpes Zoster, Pain
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loxoprofen Sodium Patch on the contralateral side and Loxoprofen Sodium Patch on the incision site in people with Loxoprofen Sodium Patch and Local Incision, run by Beijing Tiantan Hospital at 2 sites in China.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
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 Fang Luo (+86 13611326978, 13611326978@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intravenous Morphine Equivalents of Rescue Analgesic Medications Within 48 Hours Postoperatively (time frame: The postoperative period 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 NCT07591207, which also lists 3 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 16 Jun 2026.