Gastric Cancer
Conditions
Brief summary
The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.
Interventions
PROCEDUREArm 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.
PROCEDUREArm 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.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Single Blind Randomized controlled
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery. 2. Patients who have undergone a complete surgical resection (R0 resection). 3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below. 4. Patients aged 20 years or older.
Exclusion criteria
1. Patients under 19 years of age. 2. Presence of ascites or peritoneal metastasis. 3. Patients who have undergone preoperative chemotherapy or radiotherapy. 4. Diagnosis of malignancies other than gastric cancer. 5. Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing. 6. History of allergy or adverse reactions to Ropivacaine or other local anesthetics. 7. Pregnant women. 8. Patients with preoperative chronic pain conditions, including CRPS. 9. Patients with long-term preoperative use of opioid analgesics. 10. Patients with psychiatric disorders deemed likely to interfere with study participation. 11. Patients with severe liver disease, renal disease, or arrhythmia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total fentanyl consumption within 72 hours postoperatively. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first flatus and bowel movement. | Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days) | Bowel function: Time to resume normal gastrointestinal activity. |
| Occurrence of postoperative nausea and vomiting (PONV). | PONV: Assessed daily for 72 hours. | PONV: Incidence of nausea and vomiting documented along with severity scores. |
| Pain intensity scores (NRS) at rest and during movement. | Pain intensity: Measured at 24, 48, and 72 hours postoperatively. | Pain intensity: Numerical Rating Scale (NRS) scores ranging from 0 (no pain) to 10 (worst pain) assessed both at rest and during movement. |
| Length of hospital stay. | Hospital stay: up to 1 month | Hospital stay: Measured in days from surgery until patient discharge. |
| Quality of recovery (QoR-15). | QoR-15: Measured at baseline and 72 hours postoperatively. | QoR-15: Recovery quality assessed using a validated 15-item questionnaire. |
| Wound healing assessment, including seroma and infection rates. | Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days) | Wound healing: Observation of seroma or infection at the surgical site. |
Countries
South Korea
Contacts
Primary ContactShiyeol Jun
Outcome results
None listed