Health TrialsbyHealthPanel

Ropivacaine-Poloxamer 407 Gel for Pain Control After Open Gastrectomy

ConditionGastric Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorGangnam Severance Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arm I (Peritoneal application group)

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: Peritoneal application groupExperimental treatment 1 intervention
Group B: Subcutaneous injection groupExperimental treatment 1 intervention
Group C: Placebo groupPlacebo comparator 2 interventions

Trial outcomes

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.

Time frame
Total fentanyl consumption within 72 hours postoperatively.

Secondary outcomes

1

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

Pain intensity: Numerical Rating Scale (NRS) scores ranging from 0 (no pain) to 10 (worst pain) assessed both at rest and during movement.

Time frame
Pain intensity: Measured at 24, 48, and 72 hours postoperatively.
2

Time to first flatus and bowel movement.

Bowel function: Time to resume normal gastrointestinal activity.

Time frame
Bowel function: Time to first flatus and bowel movement recorded until discahrge (within 6 days)
3

Occurrence of postoperative nausea and vomiting (PONV).

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

Time frame
PONV: Assessed daily for 72 hours.
4

Wound healing assessment, including seroma and infection rates.

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Gangnam Severance Hospital

Lead sponsor

Source ClinicalTrials.gov
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