Gastric CancerNCT06839716
Comparison of Ropivacaine-Poloxamer 407 Hydrogel and TAP Block for Postoperative Pain Management in Laparoscopic/Robotic Gastrectomy
A study testing Arm I (Ropivacaine-Poloxamer 407 hydrogel group) and Arm II (TAP block group) in people with Gastric Cancer, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
This study aims to determine whether Ropivacaine-Poloxamer 407 hydrogel provides non-inferior pain control compared to TAP block for patients undergoing minimally invasive gastrectomy. The results will guide postoperative pain management practices and enhance recovery protocols for gastric cancer surgery. 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 (Ropivacaine-Poloxamer 407 hydrogel group) and Arm II (TAP block group)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Feb 2025to 31 Mar 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 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.
- Patients who have undergone laparoscopic or robotic gastrectomy
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
Gangnam Severance Hospital
Seoul
Shiyeol Jun, 82-2-2019-4601, gsirb@yuhs.ac
About this study
Official title: Prospective Randomized Controlled Study of Ropivacaine-Poloxamer 407 Based Gel Application and TAP Block for Postoperative Pain Management Following Laparoscopic/Robotic Gastrectomy
This study aims to determine whether Ropivacaine-Poloxamer 407 hydrogel provides non-inferior pain control compared to TAP block for patients undergoing minimally invasive gastrectomy. The results will guide postoperative pain management practices and enhance recovery protocols for gastric cancer surgery.
- Conditions
- Gastric Cancer
- Being tested
- Arm I (Ropivacaine-Poloxamer 407 hydrogel group), Arm II (TAP block 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 (Ropivacaine-Poloxamer 407 hydrogel group)Procedure or surgery
Patients receive intraoperative application of Ropivacaine-Poloxamer 407 hydrogel at the incision site. A mixture of 0.75% Ropivacaine (22.5 mg, 3 mL) and Poloxamer 407-based gel (Welpass, 6 mL) is prepared. The hydrogel is applied as 4 mL between the peritoneum and fascia, and 2 mL is injected subcutaneously around the incision before skin closure. This intervention aims to provide sustained local anesthesia for up to 72 hours.
Arm II (TAP block group)Procedure or surgery
Patients undergo ultrasound-guided subcostal transversus abdominis plane (TAP) block before anesthesia emergence. A total of 30 mL of 0.375% Ropivacaine (15 mL per side) is injected bilaterally between the internal oblique and transversus abdominis muscles. TAP block is a regional anesthesia technique known for effective postoperative pain control, typically lasting 24 to 48 hours.
Both groups receive standardized postoperative analgesia, including IV acetaminophen, fentanyl via patient-controlled analgesia (PCA), and rescue pethidine as needed.
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine-Poloxamer 407 hydrogel group | Experimental | Patients withRopivacaine-Poloxamer 407 hydrogel applied to the peritoneal and subcutaneous layers at the incision site. Receives: Procedure: Arm I (Ropivacaine-Poloxamer 407 hydrogel group) |
| TAP block group | Active comparator | Patients with Ultrasound-guided subcostal TAP block with 0.375% ropivacaine (15 mL per side). Receives: Procedure: Arm II (TAP block 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: Over the first 72 hours after surgery.
Secondary outcomes (9)
Fentanyl usage at 12, 24, 48 hours.
Pain intensity: Numerical Rating Scale (NRS) scores ranging from 0 (no pain) to 10 (worst pain) assessed both at rest and during movement.
Measured: Fentanyl usage at 12, 24, 48 hours.
NRS pain scores at 24, 48, and 72 hours (at rest and during movement).
Bowel function: Time to resume normal gastrointestinal activity.
Measured: NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).
Pethidine usage at 24, 48, 72 hours
PONV: Incidence of nausea and vomiting documented along with severity scores.
Measured: Pethidine usage at 24, 48, 72 hours
Time to first flatus and bowel movement. (up to 1 month)
The time from surgery completion to the first passage of gas and bowel movement will be recorded to assess postoperative gastrointestinal recovery.
Measured: 1 month
Incidence of seroma or surgical site infection. (up to 1 month)
The presence of seroma or surgical site infection (SSI) will be evaluated through clinical examination and recorded according to standardized criteria.
Measured: 1 month
Quality of Recovery (QoR-15) scores at baseline and 72 hours
Quality of recovery will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire, which evaluates physical comfort, emotional state, and overall well-being.(Quality of Recovery (QoR-15) score 0-10 on each items/ 0: worst recovery / 10: best recovery)
Measured: 72 hours postoperatively
Peak Cough Flow (baseline and 72 hours)
Peak cough flow (PCF) will be measured using a peak flow meter to assess respiratory function and recovery after surgery.
Measured: Baseline (preoperatively) and 72 hours postoperatively
Length of hospital stay. (up to 1 month)
The total number of days from surgery to hospital discharge will be recorded to evaluate recovery speed and efficiency.
Measured: up to 1 month
Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)
The occurrence of postoperative nausea and vomiting (PONV) will be documented, and severity will be assessed using a standardized scale.
Measured: 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 posted21 Feb 2025
- Study start1 Feb 2025
- Primary completion1 Feb 2026 (estimated)
- Study completion31 Mar 2026 (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
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 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
- NCT06839716
- Sponsor's protocol ID
- 3-2024-0451
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Study of Ropivacaine-Poloxamer 407 Based Gel Application and TAP Block for Postoperative Pain Management Following Laparoscopic/Robotic Gastrectomy
- ClinicalTrials.gov ID
- NCT06839716
- Acronym / sponsor ID
- 3-2024-0451
- Conditions
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 21 Feb 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.
This study aims to determine whether Ropivacaine-Poloxamer 407 hydrogel provides non-inferior pain control compared to TAP block for patients undergoing minimally invasive gastrectomy. The results will guide postoperative pain management practices and enhance recovery protocols for gastric cancer surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Blind Randomized controlled
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine-Poloxamer 407 hydrogel group | Experimental | Procedure: Arm I (Ropivacaine-Poloxamer 407 hydrogel group)Patients withRopivacaine-Poloxamer 407 hydrogel applied to the peritoneal and subcutaneous layers at the incision site. |
| TAP block group | Active comparator | Procedure: Arm II (TAP block group)Patients with Ultrasound-guided subcostal TAP block with 0.375% ropivacaine (15 mL per side). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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.
- Patients who have undergone laparoscopic or robotic gastrectomy
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 (Ropivacaine-Poloxamer 407 hydrogel group)Patients receive intraoperative application of Ropivacaine-Poloxamer 407 hydrogel at the incision site. A mixture of 0.75% Ropivacaine (22.5 mg, 3 mL) and Poloxamer 407-based gel (Welpass, 6 mL) is prepared. The hydrogel is applied as 4 mL between the peritoneum and fascia, and 2 mL is injected subcutaneously around the incision before skin closure. This intervention aims to provide sustained local anesthesia for up to 72 hours. | Procedure or surgery | Ropivacaine-Poloxamer 407 hydrogel group |
| Arm II (TAP block group)Patients undergo ultrasound-guided subcostal transversus abdominis plane (TAP) block before anesthesia emergence. A total of 30 mL of 0.375% Ropivacaine (15 mL per side) is injected bilaterally between the internal oblique and transversus abdominis muscles. TAP block is a regional anesthesia technique known for effective postoperative pain control, typically lasting 24 to 48 hours. Both groups receive standardized postoperative analgesia, including IV acetaminophen, fentanyl via patient-controlled analgesia (PCA), and rescue pethidine as needed. | Procedure or surgery | TAP block group |
Primary outcome
Total fentanyl consumption within 72 hours postoperatively.
Time frame: Over the first 72 hours after surgery.
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.
9 secondary outcomes
Fentanyl usage at 12, 24, 48 hours.
Time frame: Fentanyl usage at 12, 24, 48 hours.
NRS pain scores at 24, 48, and 72 hours (at rest and during movement).
Time frame: NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).
Pethidine usage at 24, 48, 72 hours
Time frame: Pethidine usage at 24, 48, 72 hours
Time to first flatus and bowel movement. (up to 1 month)
Time frame: 1 month
Incidence of seroma or surgical site infection. (up to 1 month)
Time frame: 1 month
Quality of Recovery (QoR-15) scores at baseline and 72 hours
Time frame: 72 hours postoperatively
Peak Cough Flow (baseline and 72 hours)
Time frame: Baseline (preoperatively) and 72 hours postoperatively
Length of hospital stay. (up to 1 month)
Time frame: up to 1 month
Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)
Time frame: 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 25 Feb 2025.
- 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.
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 (Ropivacaine-Poloxamer 407 hydrogel group) and Arm II (TAP block 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 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 25 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. 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 In Gyu Kwon (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: Over the first 72 hours after surgery.). 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 25 Feb 2025.