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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
134
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.
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.
Gangnam Severance Hospital
Seoul, South Korea
RECRUITINGTotal 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.
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.
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).
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
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
Incidence of seroma or surgical site infection. (up to 1 month)
The presence of seroma or surgical site infection (SSI) will be evaluated through clinical examination and recorded according to standardized criteria.
Time frame: 1 month
Quality of Recovery (QoR-15) scores at baseline and 72 hours
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Quality of recovery will be assessed using the 15-item Quality of Recovery (QoR-15) questionnaire, which evaluates physical comfort, emotional state, and overall well-being.(Quality of Recovery (QoR-15) score 0-10 on each items/ 0: worst recovery / 10: best recovery)
Time frame: 72 hours postoperatively
Peak Cough Flow (baseline and 72 hours)
Peak cough flow (PCF) will be measured using a peak flow meter to assess respiratory function and recovery after surgery.
Time frame: Baseline (preoperatively) and 72 hours postoperatively
Length of hospital stay. (up to 1 month)
The total number of days from surgery to hospital discharge will be recorded to evaluate recovery speed and efficiency.
Time frame: up to 1 month
Incidence of postoperative nausea and vomiting (PONV). (up to 72 hours)
The occurrence of postoperative nausea and vomiting (PONV) will be documented, and severity will be assessed using a standardized scale.
Time frame: 72 hours postoperatively