Postoperative Pain
Conditions
Keywords
Postoperative pain, Stomach neoplasms, Nerve block
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.
Interventions
PROCEDUREUltrasound 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.
0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
DEVICE21G 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)
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
We plan to perform TAPB in patients under general anesthesia. Physicians not involved in this study will investigate the outcomes.
Intervention model description
A prospective randomized double-blinded study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total fentanyl consumption during 24 hours | postoperative 24 hours | postoperative cumulative fentanyl consumption (mcg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 (%) |
| Rescue nonopioid(ketorolac, nefopam) analgesic requirement | postoperative 6, 12, 24, 48 hours | Overall postoperative rescue of nonopoioid(ketorolac, nefopam) analgesic requirement |
Countries
South Korea
Outcome results
None listed