Postoperative Analgesic Effect of Subcostal TAPB for Laparoscopic Gastrectomy

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Pain

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A prospective randomized double-blinded study
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Stomach neoplasms, Nerve block