Gastric CancerNCT06778954
Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy
A study testing Arm I (Peritoneal application group) and Arm II (Subcutaneous injection group) in people with Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Arm I (Peritoneal application group) and Arm II (Subcutaneous injection group)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Jan 2025to 31 Dec 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
- Patients who have undergone a complete surgical resection (R0 resection).
- Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
- Patients aged 20 years or older.
Who cannot join
- Patients under 19 years of age.
- Presence of ascites or peritoneal metastasis.
- Patients who have undergone preoperative chemotherapy or radiotherapy.
- Diagnosis of malignancies other than gastric cancer.
- Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
- History of allergy or adverse reactions to Ropivacaine or other local anesthetics.
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- Pregnant women.
- Patients with preoperative chronic pain conditions, including CRPS.
- Patients with long-term preoperative use of opioid analgesics.
- Patients with psychiatric disorders deemed likely to interfere with study participation.
- Patients with severe liver disease, renal disease, or arrhythmia.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
GangnamSeverance Hospital
Seoul
Shiyeol Jun
About this study
Official title: Prospective Randomized Controlled Trial of Ropivacaine-Poloxamer 407 Based Gel Application on Postoperative Pain After Open Gastrectomy
The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.
- Conditions
- Gastric Cancer
- Being tested
- Arm I (Peritoneal application group), Arm II (Subcutaneous injection group)
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm I (Peritoneal application group)Procedure or surgery
At the end of gastrectomy, during closure of incision, peritoneum and fascia are closed by suture, layer by layer. Skin approximation is doen with skin stapler. Ropivacaine-Poloxamer 407 hydrogel is applied on space between peritoneum and fascia in Arm I.
Arm II (Subcutaneous injection group)Procedure or surgery
At the end of gastrectomy, during closure of incision, peritoneum and fascia are closed by suture, layer by layer. Skin approximation is doen with skin stapler. Ropivacaine-Poloxamer 407 hydrogel is injected on subcutaneous area in Arm II.
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal application group | Experimental | Patients who applied Ropivacaine-Poloxamer 407 hydrogel on space between peritoneum and fascia Receives: Procedure: Arm I (Peritoneal application group) |
| Subcutaneous injection group | Experimental | Patients who injected Ropivacaine-Poloxamer 407 hydrogel on subcutaneous area Receives: Procedure: Arm II (Subcutaneous injection group) |
| Placebo group | Placebo comparator | Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel Receives: Procedure: Arm I (Peritoneal application group); Procedure: Arm II (Subcutaneous injection group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fentanyl consumption within 72 hours postoperatively.
The total amount of fentanyl administered to the patient via IV PCA during the initial 72-hour postoperative period will be recorded and compared among groups to assess analgesic efficacy.
Measured: Total fentanyl consumption within 72 hours postoperatively.
Secondary outcomes (6)
Pain intensity scores (NRS) at rest and during movement.
Pain intensity: Numerical Rating Scale (NRS) scores ranging from 0 (no pain) to 10 (worst pain) assessed both at rest and during movement.
Measured: Pain intensity: Measured at 24, 48, and 72 hours postoperatively.
Time to first flatus and bowel movement.
Bowel function: Time to resume normal gastrointestinal activity.
Measured: Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days)
Occurrence of postoperative nausea and vomiting (PONV).
PONV: Incidence of nausea and vomiting documented along with severity scores.
Measured: PONV: Assessed daily for 72 hours.
Wound healing assessment, including seroma and infection rates.
Wound healing: Observation of seroma or infection at the surgical site.
Measured: Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days)
Length of hospital stay.
Hospital stay: Measured in days from surgery until patient discharge.
Measured: Hospital stay: up to 1 month
Quality of recovery (QoR-15).
QoR-15: Recovery quality assessed using a validated 15-item questionnaire.
Measured: QoR-15: Measured at baseline and 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 posted16 Jan 2025
- Study start30 Jan 2025
- Primary completion1 Nov 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blind Randomized controlled
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In Gyu Kwon, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06778954
- Sponsor's protocol ID
- 3-2024-0383
- Status last verified
- Feb 2025
- First submitted
- 5 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Ropivacaine-Poloxamer 407 Based Gel Application on Postoperative Pain After Open Gastrectomy
- ClinicalTrials.gov ID
- NCT06778954
- Acronym / sponsor ID
- 3-2024-0383
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jan 2025 (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.
The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Single Blind Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Peritoneal application group | Experimental | Procedure: Arm I (Peritoneal application group)Patients who applied Ropivacaine-Poloxamer 407 hydrogel on space between peritoneum and fascia |
| Subcutaneous injection group | Experimental | Procedure: Arm II (Subcutaneous injection group)Patients who injected Ropivacaine-Poloxamer 407 hydrogel on subcutaneous area |
| Placebo group | Placebo comparator | Procedure: Arm I (Peritoneal application group), Procedure: Arm II (Subcutaneous injection group)Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
- Patients who have undergone a complete surgical resection (R0 resection).
- Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
- Patients aged 20 years or older.
Key exclusion criteria (11 listed)
- Patients under 19 years of age.
- Presence of ascites or peritoneal metastasis.
- Patients who have undergone preoperative chemotherapy or radiotherapy.
- Diagnosis of malignancies other than gastric cancer.
- Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
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 |
|---|---|---|
| Arm I (Peritoneal application group)At the end of gastrectomy, during closure of incision, peritoneum and fascia are closed by suture, layer by layer. Skin approximation is doen with skin stapler. Ropivacaine-Poloxamer 407 hydrogel is applied on space between peritoneum and fascia in Arm I. | Procedure or surgery | Peritoneal application group, Placebo group |
| Arm II (Subcutaneous injection group)At the end of gastrectomy, during closure of incision, peritoneum and fascia are closed by suture, layer by layer. Skin approximation is doen with skin stapler. Ropivacaine-Poloxamer 407 hydrogel is injected on subcutaneous area in Arm II. | Procedure or surgery | Placebo group, Subcutaneous injection group |
Primary outcome
Total fentanyl consumption within 72 hours postoperatively.
Time frame: Total fentanyl consumption within 72 hours postoperatively.
The total amount of fentanyl administered to the patient via IV PCA during the initial 72-hour postoperative period will be recorded and compared among groups to assess analgesic efficacy.
6 secondary outcomes
Pain intensity scores (NRS) at rest and during movement.
Time frame: Pain intensity: Measured at 24, 48, and 72 hours postoperatively.
Time to first flatus and bowel movement.
Time frame: Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days)
Occurrence of postoperative nausea and vomiting (PONV).
Time frame: PONV: Assessed daily for 72 hours.
Wound healing assessment, including seroma and infection rates.
Time frame: Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days)
Length of hospital stay.
Time frame: Hospital stay: up to 1 month
Quality of recovery (QoR-15).
Time frame: QoR-15: Measured at baseline and 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 14 Feb 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm I (Peritoneal application group) and Arm II (Subcutaneous injection group) in people with Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
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 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 14 Feb 2025. 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 South Korea. 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. Some participants in this study may receive a placebo. 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 Shiyeol Jun (82-2-2019-4601, gsirb@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total fentanyl consumption within 72 hours postoperatively. (time frame: Total fentanyl consumption within 72 hours postoperatively.). 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 14 Feb 2025.