Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work?

Study Overview
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Brief Summary
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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
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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.

Official Title
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Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work? A Randomized Controlled Clinical Trial of Microtia Patients

Conditions
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Rectus Abdominis and External Oblique Muscle Infiltration Analgesia

Intervention / Treatment
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* Procedure: rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia
* Procedure: intravenous patient-controlled anesthesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group-PCIA<br> | Procedure: intravenous patient-controlled anesthesia<br>* After completion of the operation, the anesthesiologist used the IPCA device; it was programmed with a background infusion rate of 2 mL/h, a bolus volume of 2 mL, and a lockout interval of 15 minutes. The 100 mL total volume of the PCA consisted of normal saline, 2.0 ug/kg sufentanil, and adjuvant antiemetic (tropisetron).<br>|
| Experimental: Group-IA+PCIA<br> | Procedure: rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia<br>* After suturing the muscular fascia, an indwelling catheter was placed above the RAM and EOM and under the subcutaneous tissue and then sutured to the skin for fixation. Approximately 30 min before surgery completion, 1 mg/kg of 0.2% ropivacaine was infused through the indwelling catheter for IA. Additionally, 1 mg/kg of 0.2% ropivacaine was infused through the indwelling catheter every 12 h, starting 8 h postoperatively, injected four times.<br>Procedure: intravenous patient-controlled anesthesia<br>* After completion of the operation, the anesthesiologist used the IPCA device; it was programmed with a background infusion rate of 2 mL/h, a bolus volume of 2 mL, and a lockout interval of 15 minutes. The 100 mL total volume of the PCA consisted of normal saline, 2.0 ug/kg sufentanil, and adjuvant antiemetic (tropisetron).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating scale | The primary outcome was the numerical rating score (NRS) of pain recorded during 48 h postoperatively | 4,8,12,16,20,24,28,32,36,40,44,48hours after surgery | 
| Rescue analgesics consumption | Rescue analgesics were administered only on demand and not routinely. During the postoperative days, physicians prescribed 15 mg/kg oral acetaminophen if the pain was unbearable. | 48hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barthel's index | The Barthel's index measures the ability to perform daily activities after surgery | 24hours after surgery |