An interventional study of Type of interfascial plane block in Postoperative Pain, Acute, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
This randomized controlled study is designed to evaluate the postoperative analgesic effect of the ultrasound-guided modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The investigators hypothesized that the US-guided M-TAPA would be more effective in postoperative pain control than the US-guided subcostal transversus abdominis plane block (TAPB).
Patients (Age>18 years) undergoing elective laparoscopic cholecystectomy are randomly allocated to receive bilateral US-guided M-TAPA (n=30) or bilateral subcostal TAPB (n=30) using 0.375% ropivacaine 15ml (total 30ml) before surgical incision. The blinded investigator evaluates each patient's parameters (Numeric rating scale, nausea, vomiting, pruritis, and patient satisfaction) at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge. The primary outcome is pain severity evaluated by a NRS at 12hours postoperatively.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 60 is below the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receiving right M-TAPA.
Procedure: Type of interfascial plane block
Patients receiving right subcostal TAPB.
Procedure: Type of interfascial plane block
In the M-TAPA group, after finding the right 10th costal cartilage using ultrasound guidance, a anesthesiologist inject 0.375% ropivacaine 15ml into the lower aspect of the chondrium. Perform left M-TAPA in the same way. In the subcostal TAPB group, a anesthesiologist inject 0.375% ropivacaine 15ml into end of right rectus abdominis muscle using ultrasound guidance. Perform left subcostal TAPB in the same way.
Maximum postoperative pain score during 12hours postoperatively
maximum pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) during 12hours postoperatively
Time frame: at 12hour postoperatively.
Postoperative pain score at rest
Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score at resting
Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
Postoperative pain score during coughing
Change in the pain severity measured by the 11-pointed numeric rating scale (0: none/10: worst pain) pain score during coughing
Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge
Patient satisfaction before discharge
Patient satisfaction measured by the 7-pointed Likert scale. (1: Strongly dissatisfaction/ 7: Strongly satisfaction)
Time frame: at immediately before discharge
Occurrence rate of postoperative nausea, vomiting
Incidence of postoperative nausea and vomiting (%)
Time frame: at 1, 2, 4, 6, 12hours postoperatively, and immediately before discharge.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital