Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06118216
Enrollment
60
Registered
2023-11-07
Start date
2022-12-01
Completion date
2023-07-01
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectus Abdominis and External Oblique Muscle Infiltration Analgesia

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.

Interventions

PROCEDURErectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia

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.

PROCEDUREintravenous patient-controlled anesthesia

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).

Sponsors

Xiaohui Su
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
numeric rating scale4,8,12,16,20,24,28,32,36,40,44,48hours after surgeryThe primary outcome was the numerical rating score (NRS) of pain recorded during 48 h postoperatively
Rescue analgesics consumption48hours after surgeryRescue 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.

Secondary

MeasureTime frameDescription
Barthel's index24hours after surgeryThe Barthel's index measures the ability to perform daily activities after surgery

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026