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The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peritoneal application group | Experimental | Patients who applied Ropivacaine-Poloxamer 407 hydrogel on space between peritoneum and fascia |
|
| Subcutaneous injection group | Experimental | Patients who injected Ropivacaine-Poloxamer 407 hydrogel on subcutaneous area |
|
| Placebo group | Placebo Comparator | Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm I (Peritoneal application group) | Procedure | 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. |
| Measure | Description | 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. | Total fentanyl consumption within 72 hours postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pain intensity: Measured at 24, 48, and 72 hours postoperatively. |
| Time to first flatus and bowel movement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shiyeol Jun | Contact | 82-2-2019-4601 | gsirb@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GangnamSeverance Hospital | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Single Blind Randomized controlled
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|
| Arm II (Subcutaneous injection group) | Procedure | 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. |
|
Bowel function: Time to resume normal gastrointestinal activity. |
| 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. | 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. | 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. | Hospital stay: up to 1 month |
| Quality of recovery (QoR-15). | QoR-15: Recovery quality assessed using a validated 15-item questionnaire. | QoR-15: Measured at baseline and 72 hours postoperatively. |
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |