Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06839716

Comparison of Ropivacaine-Poloxamer 407 Hydrogel and TAP Block for Postoperative Pain Management in Laparoscopic/Robotic Gastrectomy

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.

Recruiting

Interested in participating?

Request Info

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

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.
  • Patients who have undergone laparoscopic or robotic gastrectomy

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 (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.

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.

Primary outcomes

  1. Total fentanyl consumption within 72 hours postoperatively.

    Time frame: Over the first 72 hours after surgery.

    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. Fentanyl usage at 12, 24, 48 hours.

    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.

  2. NRS pain scores at 24, 48, and 72 hours (at rest and during movement).

    Time frame: NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).

    Bowel function: Time to resume normal gastrointestinal activity.

  3. Pethidine usage at 24, 48, 72 hours

    Time frame: Pethidine usage at 24, 48, 72 hours

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

  4. Time to first flatus and bowel movement. (up to 1 month)

    Time frame: 1 month

    The time from surgery completion to the first passage of gas and bowel movement will be recorded to assess postoperative gastrointestinal recovery.

  5. Incidence of seroma or surgical site infection. (up to 1 month)

    Time frame: 1 month

    The presence of seroma or surgical site infection (SSI) will be evaluated through clinical examination and recorded according to standardized criteria.

  6. Quality of Recovery (QoR-15) scores at baseline and 72 hours

    Time frame: 72 hours postoperatively

    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)

  7. Peak Cough Flow (baseline and 72 hours)

    Time frame: Baseline (preoperatively) and 72 hours postoperatively

    Peak cough flow (PCF) will be measured using a peak flow meter to assess respiratory function and recovery after surgery.

  8. Length of hospital stay. (up to 1 month)

    Time frame: up to 1 month

    The total number of days from surgery to hospital discharge will be recorded to evaluate recovery speed and efficiency.

  9. Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)

    Time frame: 72 hours postoperatively

    The occurrence of postoperative nausea and vomiting (PONV) will be documented, and severity will be assessed using a standardized scale.

Study contacts

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

In Gyu Kwon

CONTACT

[email protected]

82-2-2019-4601

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

Prospective Randomized Controlled Study of Ropivacaine-Poloxamer 407 Based Gel Application and TAP Block for Postoperative Pain Management Following Laparoscopic/Robotic Gastrectomy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 21, 2025
Registry last updated
Feb 25, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.