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Clinical Trials/NCT06839716
NCT06839716RecruitingNot Applicable

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

Gangnam Severance Hospital1 site in 1 country134 target enrollmentStarted: February 1, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
134
Locations
1
Primary Endpoint
Total fentanyl consumption within 72 hours postoperatively.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Ropivacaine-Poloxamer 407 hydrogel group

Experimental

Patients withRopivacaine-Poloxamer 407 hydrogel applied to the peritoneal and subcutaneous layers at the incision site.

Intervention: Arm I (Ropivacaine-Poloxamer 407 hydrogel group) (Procedure)

TAP block group

Active Comparator

Patients with Ultrasound-guided subcostal TAP block with 0.375% ropivacaine (15 mL per side).

Intervention: Arm II (TAP block group) (Procedure)

Outcomes

Primary Outcomes

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

  • Length of hospital stay. (up to 1 month)(up to 1 month)
  • Fentanyl usage at 12, 24, 48 hours.(Fentanyl usage at 12, 24, 48 hours.)
  • NRS pain scores at 24, 48, and 72 hours (at rest and during movement).(NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).)
  • Pethidine usage at 24, 48, 72 hours(Pethidine usage at 24, 48, 72 hours)
  • Time to first flatus and bowel movement. (up to 1 month)(1 month)
  • Incidence of seroma or surgical site infection. (up to 1 month)(1 month)
  • Quality of Recovery (QoR-15) scores at baseline and 72 hours(72 hours postoperatively)
  • Peak Cough Flow (baseline and 72 hours)(Baseline (preoperatively) and 72 hours postoperatively)
  • Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)(72 hours postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

In Gyu Kwon

Assistant Professor

Gangnam Severance Hospital

Study Sites (1)

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