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

Sponsor
Xiaohui Su (Other)
Overall Status
Completed
CT.gov ID
NCT06118216
Collaborator
(none)
60
1
2
7
8.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia
  • Procedure: intravenous patient-controlled anesthesia
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work? A Randomized Controlled Clinical Trial of Microtia Patients
Actual Study Start Date :
Dec 1, 2022
Actual Primary Completion Date :
Jun 1, 2023
Actual Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Group-PCIA

Procedure: intravenous 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).

Experimental: Group-IA+PCIA

Procedure: rectus 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.

Procedure: intravenous 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).

Outcome Measures

Primary Outcome Measures

  1. numeric rating scale [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

  2. Rescue analgesics consumption [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 Outcome Measures

  1. Barthel's index [24hours after surgery]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
8 Years to 18 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 The First Affiliated Hospital of Fujian Medical University Fuzhou Fujian China 350000

Sponsors and Collaborators

  • Xiaohui Su

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Xiaohui Su, clinical physician, First Affiliated Hospital of Fujian Medical University
ClinicalTrials.gov Identifier:
NCT06118216
Other Study ID Numbers:
  • CCDPDAMIAW
First Posted:
Nov 7, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 7, 2023