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

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

About this trial

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.

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 (Ropivacaine-Poloxamer 407 hydrogel group)

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

134 Participants
are divided into 2 treatment groups
Group A: Ropivacaine-Poloxamer 407 hydrogel groupExperimental treatment 1 intervention
Group B: TAP block groupActive comparator 1 intervention

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
Over the first 72 hours after surgery.

Secondary outcomes

1

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.

Time frame
Fentanyl usage at 12, 24, 48 hours.
2

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

Bowel function: Time to resume normal gastrointestinal activity.

Time frame
NRS pain scores(0-10 / 0: no pain / 10: worst pain) at 24, 48, and 72 hours (at rest and during movement).
3

Pethidine usage at 24, 48, 72 hours

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

Time frame
Pethidine usage at 24, 48, 72 hours
4

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

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

Time frame
1 month

Other outcomes

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