Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

February 13, 2025 updated by: In Gyu Kwon, Gangnam Severance Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shiyeol Jun
  • Phone Number: 82-2-2019-4601
  • Email: gsirb@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • GangnamSeverance Hospital
        • Contact:
          • Shiyeol Jun

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Peritoneal application group
Patients who applied Ropivacaine-Poloxamer 407 hydrogel on space between peritoneum and fascia
Procedure: Arm I (Peritoneal application group)
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.
Experimental: Subcutaneous injection group
Patients who injected Ropivacaine-Poloxamer 407 hydrogel on subcutaneous area
Procedure: Arm II (Subcutaneous injection group)
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 Comparator: Placebo group
Patients who did not apply Ropivacaine-Poloxamer 407 hydrogel
Procedure: Arm I (Peritoneal application group)
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.
Procedure: Arm II (Subcutaneous injection group)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Total fentanyl consumption within 72 hours postoperatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pain intensity: Measured at 24, 48, and 72 hours postoperatively.
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.
Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days)
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.
PONV: Assessed daily for 72 hours.
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.
Wound healing: Evaluated at regular intervals until first outpatient day (within 14 days)
Length of hospital stay.
Time Frame: Hospital stay: up to 1 month
Hospital stay: Measured in days from surgery until patient discharge.
Hospital stay: up to 1 month
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.
QoR-15: Measured at baseline and 72 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 5, 2025

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 13, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2024-0383

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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