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NCT Number: NCT06778954

Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

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

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeverance Hospital

Seoul, South Korea

Location status: Recruiting

Location contact

Shiyeol Jun

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery.
  • Patients who have undergone a complete surgical resection (R0 resection).
  • Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
  • Patients aged 20 years or older.

Exclusion criteria

  • Patients under 19 years of age.
  • Presence of ascites or peritoneal metastasis.
  • Patients who have undergone preoperative chemotherapy or radiotherapy.
  • Diagnosis of malignancies other than gastric cancer.
  • Uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing.
  • History of allergy or adverse reactions to Ropivacaine or other local anesthetics.
  • Pregnant women.
  • Patients with preoperative chronic pain conditions, including CRPS.
  • Patients with long-term preoperative use of opioid analgesics.
  • Patients with psychiatric disorders deemed likely to interfere with study participation.
  • Patients with severe liver disease, renal disease, or arrhythmia.

Treatment and study plan

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

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.

Primary outcomes

  1. Total fentanyl consumption within 72 hours postoperatively.

    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.

Secondary outcomes

  1. Pain intensity scores (NRS) at rest and during movement.

    Time frame: 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.

  2. Time to first flatus and bowel movement.

    Time frame: Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days)

    Bowel function: Time to resume normal gastrointestinal activity.

  3. Occurrence of postoperative nausea and vomiting (PONV).

    Time frame: PONV: Assessed daily for 72 hours.

    PONV: Incidence of nausea and vomiting documented along with severity scores.

  4. Wound healing assessment, including seroma and infection rates.

    Time frame: Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days)

    Wound healing: Observation of seroma or infection at the surgical site.

  5. Length of hospital stay.

    Time frame: Hospital stay: up to 1 month

    Hospital stay: Measured in days from surgery until patient discharge.

  6. Quality of recovery (QoR-15).

    Time frame: QoR-15: Measured at baseline and 72 hours postoperatively.

    QoR-15: Recovery quality assessed using a validated 15-item questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Shiyeol Jun

CONTACT

[email protected]

82-2-2019-4601

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Prospective Randomized Controlled Trial of Ropivacaine-Poloxamer 407 Based Gel Application on Postoperative Pain After Open Gastrectomy

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 16, 2025
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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