NCT06778954

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started Jan 2025

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 16, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

January 30, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 14, 2025

Status Verified

February 1, 2025

Enrollment Period

9 months

First QC Date

January 5, 2025

Last Update Submit

February 13, 2025

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    Total fentanyl consumption within 72 hours postoperatively.

Secondary Outcomes (6)

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

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

  • Time to first flatus and bowel movement.

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

  • Occurrence of postoperative nausea and vomiting (PONV).

    PONV: Assessed daily for 72 hours.

  • Wound healing assessment, including seroma and infection rates.

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

  • Length of hospital stay.

    Hospital stay: up to 1 month

  • +1 more secondary outcomes

Study Arms (3)

Peritoneal application group

EXPERIMENTAL

Patients who applied Ropivacaine-Poloxamer 407 hydrogel on space between peritoneum and fascia

Procedure: Arm I (Peritoneal application group)

Subcutaneous injection group

EXPERIMENTAL

Patients who injected Ropivacaine-Poloxamer 407 hydrogel on subcutaneous area

Procedure: Arm II (Subcutaneous injection group)

Placebo group

PLACEBO COMPARATOR

Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel

Procedure: Arm I (Peritoneal application group)Procedure: Arm II (Subcutaneous injection group)

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.

Peritoneal application groupPlacebo group
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.

Placebo groupSubcutaneous injection group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Central Study Contacts

Shiyeol Jun

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Single Blind Randomized controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 5, 2025

First Posted

January 16, 2025

Study Start

January 30, 2025

Primary Completion

November 1, 2025

Study Completion

December 31, 2025

Last Updated

February 14, 2025

Record last verified: 2025-02

Locations

KR(1)