Clinical trial NCT06118216: Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work?
Official title: Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work? A Randomized Controlled Clinical Trial of Microtia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectus Abdominis and External Oblique Muscle Infiltration Analgesia
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* All patients were microtia and underwent the first stage of autologous ear reconstruction by the same experienced surgeon in First Affiliated Hospital of Fujian Medical University.

Exclusion Criteria:

* Patients were excluded if they over 18 years old; discontinued analgesic therapy; regularly used opioids, other analgesics, sedative medications, or corticosteroids; were unable to express pain scores due to comorbidities such as mental retardation; or had incomplete data.

Primary outcomes:
measure: numeric rating scale
timeFrame: 4,8,12,16,20,24,28,32,36,40,44,48hours after surgery
measure: Rescue analgesics consumption
timeFrame: 48hours after surgery
Secondary outcomes:
measure: Barthel's index
timeFrame: 24hours after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
Study officials:
References:
citation: Niiyama Y, Yotsuyanagi T, Yamakage M. Continuous wound infiltration with 0.2% ropivacaine versus a single intercostal nerve block with 0.75% ropivacaine for postoperative pain management after reconstructive surgery for microtia. J Plast Reconstr Aesthet Surg. 2016 Oct;69(10):1445-9. doi: 10.1016/j.bjps.2016.05.009. Epub 2016 Jun 2.
citation: Woo KJ, Kang BY, Min JJ, Park JW, Kim A, Oh KS. Postoperative pain control by preventive intercostal nerve block under direct vision followed by catheter-based infusion of local analgesics in rib cartilage harvest for auricular reconstruction in children with microtia: A randomized controlled trial. J Plast Reconstr Aesthet Surg. 2016 Sep;69(9):1203-10. doi: 10.1016/j.bjps.2016.06.026. Epub 2016 Jul 9.
citation: Shaffer AD, Jabbour N, Visoiu M, Yang CI, Yellon RF. Paravertebral Nerve Block for Donor Site Pain in Stage I Microtia Reconstruction: A Pilot Study. Otolaryngol Head Neck Surg. 2016 May;154(5):898-901. doi: 10.1177/0194599816629395. Epub 2016 Feb 23.