Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB); Drug: Ropivacaine 0.75% Injectable Solution; Device: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)

• Registration Number: NCT04138901
• Lead Sponsor: Seoul National University Hospital

Brief Summary

This prospective, randomized, single blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided subcostal transversus abdominis plane block in gastric cancer patients undergoing laparoscopic gastrectomy. We hypothesize that US guided subcostal TAP block with ropivacaine can significantly reduce postoperative opioid comparison in patients with laparoscopic gastrectomy.

Detailed Description

Adult patients undergoing elective laparoscopic gastrectomy are randomly allocated to receive subcostal TAP block (n=56) or not (n=56), in addition to a standard postoperative analgesic regimen comprising of IV fentanyl-based patient-controlled analgesia (PCA) and NSAIDs as required. At the end of surgery, the TAP group patients will receive bilateral subcostal TAP block under ultrasound guidance with 15ml of 0.375% ropivacaine bilaterally. Each patient was assessed by a blinded investigator at 6, 12, 24, and 48 h postoperatively. The primary outcome is total fentanyl consumption at 24 h after surgery.

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Study Start: 2019-11-04
• Primary Completion: 2020-05-30
• Study Completion: 2020-06-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-11
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• Patients scheduled to undergo elective laparoscopic gastrectomy under general anesthesia
• American Society of Anesthesiologists (ASA) physical classification I-III
• Consent to IV-patient controlled analgesia use
• Willingness and ability to sign an informed consent document

Exclusion Criteria

• Do not understand our study
• Allergies to anesthetic or analgesic medications
• Wound infiltration analgesia for postoperative pain control
• Infection or anatomic abnormality at the needle insertion site
• Pregnancy/Breast feeder
• Medical or psychological disease that can affect the treatment response

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group T	Ultrasound guided subcostal transversus abdominis plane block (TAPB)	Patients receiving bilateral subcostal TAP block.
Group T	21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)	Patients receiving bilateral subcostal TAP block.
Group T	Ropivacaine 0.75% Injectable Solution	Patients receiving bilateral subcostal TAP block.

Primary Outcome Measures

Name	Time	Method
Total fentanyl consumption during 24 hours	postoperative 24 hours	postoperative cumulative fentanyl consumption (mcg)

Secondary Outcome Measures

Name	Time	Method
Rescue nonopioid(ketorolac, nefopam) analgesic requirement	postoperative 6, 12, 24, 48 hours	Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement
Total fentanyl consumption	postoperative 6, 12, 48 hours	postoperative cumulative fentanyl consumption (mcg)
Postoperative pain score	postoperative 6, 12, 24, 48 hours	11-pointed NRS pain score at resting/coughing NRS (0-10): 0, "no pain"; 10, "worst pain imaginable"
occurrence of opioid-related side effects	postoperative 6, 12, 24, 48 hours	Incidence of postoperative nausea and vomiting, dizziness, sedation, respiratory depression (%)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of