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Clinical Trial Summary

Donor-site pain is an adverse effect of autologous ear reconstruction. A well-planned pain management protocol is needed. The objective of this study was to introduce rectus abdominis and external oblique muscle infiltration analgesia (RAM+EOM-IA) in autologous ear reconstruction and to evaluate its efficacy and safety.


Clinical Trial Description

Patients were included in two cohorts: intermittent RAM+EOM-IA combined with intravenous patient-controlled anesthesia (IPCA) and IPCA alone. The primary outcome was the numerical rating score (NRS) of pain recorded during 48 h postoperatively. Secondary outcomes included the Barthel index and rescue analgesic consumption. Additionally, areas of sensory block were tested using a cold stimulus. ;


Study Design


NCT number NCT06118216
Study type Interventional
Source First Affiliated Hospital of Fujian Medical University
Contact
Status Completed
Phase N/A
Start date December 1, 2022
Completion date July 1, 2023