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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group T | Experimental | Patients receiving bilateral subcostal TAP block. |
|
| Group C | No Intervention | Patients not receiving bilateral subcostal TAP block. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound guided subcostal transversus abdominis plane block (TAPB) | Procedure | At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance. |
| Measure | Description | Time Frame |
|---|---|---|
| Total fentanyl consumption during 24 hours | postoperative cumulative fentanyl consumption (mcg) | postoperative 24 hours |
| 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" |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hojin Lee, MD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | KS013 | South Korea |
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A prospective randomized double-blinded study
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We plan to perform TAPB in patients under general anesthesia. Physicians not involved in this study will investigate the outcomes.
|
| Ropivacaine 0.75% Injectable Solution | Drug | 0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) |
|
| 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) | Device | 0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France) |
|
| 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 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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