Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

Ultrasound-guided Subcostal Transversus Abdominis Plane Block in Gastric Cancer Patients Undergoing Laparoscopic Gastrectomy: A Randomized Controlled Double-blinded Study

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Pain
• Intervention / Treatment: 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)

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 Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, KS013
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group T; Patients receiving bilateral subcostal TAP block.	Procedure: Ultrasound guided subcostal transversus abdominis plane block (TAPB); At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.; Other Names: TAP block; Drug: Ropivacaine 0.75% Injectable Solution; 0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France); Device: 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France); 0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
No Intervention: Group C; Patients not receiving bilateral subcostal TAP block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total fentanyl consumption during 24 hours	postoperative cumulative fentanyl consumption (mcg)	postoperative 24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Actual): May 30, 2020
• Study Completion (Actual): June 7, 2020

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): August 13, 2020
• Last Update Submitted That Met QC Criteria: August 11, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative pain; Nerve block; Stomach neoplasms
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: HS-2019-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No