Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

Gangnam Severance Hospital48 enrolled

Overview

The study evaluates the efficacy of Ropivacaine-Poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Gastric Cancer

Interventions

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.

Arm II (Subcutaneous injection group)PROCEDURE

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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.

Locations (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Total fentanyl consumption within 72 hours postoperatively.

Secondary Outcomes

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.

Time frame: Pain intensity: Measured at 24, 48, and 72 hours postoperatively.

Time to first flatus and bowel movement.

Bowel function: Time to resume normal gastrointestinal activity.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Hospital stay: up to 1 month

Quality of recovery (QoR-15).

Central Contacts

Shiyeol Jun

CONTACT

82-2-2019-4601 gsirb@yuhs.ac

Data from ClinicalTrials.gov

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