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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine-Poloxamer 407 hydrogel group | Experimental | Patients withRopivacaine-Poloxamer 407 hydrogel applied to the peritoneal and subcutaneous layers at the incision site. |
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| TAP block group | Active Comparator | Patients with Ultrasound-guided subcostal TAP block with 0.375% ropivacaine (15 mL per side). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm I (Ropivacaine-Poloxamer 407 hydrogel group) | Procedure | 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. |
| 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. | Over the first 72 hours after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Fentanyl usage at 12, 24, 48 hours. |
| NRS pain scores at 24, 48, and 72 hours (at rest and during movement). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| In Gyu Kwon | Contact | 82-2-2019-4601 | gsirb@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Recruiting | Seoul | South Korea |
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Single Blind Randomized controlled
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| Arm II (TAP block group) | Procedure | 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. |
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Bowel function: Time to resume normal gastrointestinal activity. |
| 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. | 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. | 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. | 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) | 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. | 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. | 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. | 72 hours postoperatively |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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