Clinical trial NCT06839716: Comparison of Ropivacaine-Poloxamer 407 Hydrogel and TAP Block for Postoperative Pain Management in Laparoscopic/Robotic Gastrectomy
Official title: Prospective Randomized Controlled Study of Ropivacaine-Poloxamer 407 Based Gel Application and TAP Block for Postoperative Pain Management Following Laparoscopic/Robotic Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastric Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 134
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Blind Randomized controlled
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.
5. Patients who have undergone laparoscopic or robotic gastrectomy

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.

Primary outcomes:
measure: Total fentanyl consumption within 72 hours postoperatively.
timeFrame: Over the first 72 hours after surgery.
Secondary outcomes:
measure: Fentanyl usage at 12, 24, 48 hours.
timeFrame: Fentanyl usage at 12, 24, 48 hours.
measure: NRS pain scores at 24, 48, and 72 hours (at rest and during movement).
timeFrame: NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).
measure: Pethidine usage at 24, 48, 72 hours
timeFrame: Pethidine usage at 24, 48, 72 hours
measure: Time to first flatus and bowel movement. (up to 1 month)
timeFrame: 1 month
measure: Incidence of seroma or surgical site infection. (up to 1 month)
timeFrame: 1 month
measure: Quality of Recovery (QoR-15) scores at baseline and 72 hours
timeFrame: 72 hours postoperatively
measure: Peak Cough Flow (baseline and 72 hours)
timeFrame: Baseline (preoperatively) and 72 hours postoperatively
measure: Length of hospital stay. (up to 1 month)
timeFrame: up to 1 month
measure: Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)
timeFrame: 72 hours postoperatively
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
References: