Completed

NCT Number: NCT06118216

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

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.

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Key information

Conditions

Rectus Abdominis and External Oblique Muscle Infiltration Analgesia

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, 350000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Procedure

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.

intravenous patient-controlled anesthesia

Procedure

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).

Primary outcomes

numeric rating scale

Time frame: 4,8,12,16,20,24,28,32,36,40,44,48hours after surgery

The primary outcome was the numerical rating score (NRS) of pain recorded during 48 h postoperatively
Rescue analgesics consumption

Time frame: 48hours after surgery

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.

Secondary outcomes

Barthel's index

Time frame: 24hours after surgery

The Barthel's index measures the ability to perform daily activities after surgery

Sponsors and collaborators

Lead sponsor

Xiaohui Su

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Nov 7, 2023
Registry last updated: Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.