Rectus Abdominis and External Oblique Muscle Infiltration AnalgesiaNCT06118216
Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work?
A study testing rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia in people with Rectus Abdominis and External Oblique Muscle Infiltration Analgesia, run by Xiaohui Su at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Rectus Abdominis and External Oblique Muscle Infiltration Analgesia
- What is being tested?
- rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, 350000
About this study
Official title: Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work? A Randomized Controlled Clinical Trial of Microtia Patients
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.
Read the 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.
- Being tested
- rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia, intravenous patient-controlled anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesiaProcedure or surgery
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 anesthesiaProcedure or surgery
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).
| Study group | Role | What they receive |
|---|---|---|
| Group-PCIA | Placebo comparator | Not described Receives: Procedure: intravenous patient-controlled anesthesia |
| Group-IA+PCIA | Experimental | Not described Receives: Procedure: rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia; Procedure: intravenous patient-controlled anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
numeric rating scale
The primary outcome was the numerical rating score (NRS) of pain recorded during 48 h postoperatively
Measured: 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.
Measured: 48hours after surgery
Secondary outcomes (1)
Barthel's index
The Barthel's index measures the ability to perform daily activities after surgery
Measured: 24hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2022
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Rectus Abdominis and External Oblique Muscle Infiltration AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiaohui Su
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiaohui Su, First Affiliated Hospital of Fujian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118216
- Sponsor's protocol ID
- CCDPDAMIAW
- Status last verified
- Nov 2023
- First submitted
- 31 Oct 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27350268Woo 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.
PubMed 27430605Shaffer 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.
PubMed 26908556Wei S, Ye J, Lei C, Huang Q, Lin B, Su X, Zheng H, Shan X, Wang B, Wang M. Abdominal muscles infiltration analgesia for donor-site pain in autologous ear reconstruction: A randomized controlled clinical trial. J Plast Reconstr Aesthet Surg. 2024 Dec;99:38-46. doi: 10.1016/j.bjps.2024.09.019. Epub 2024 Sep 20.
PubMed 39342766
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costal Cartilage Donor-site Pain: Does Abdominal Muscle Infiltration Analgesia Work? A Randomized Controlled Clinical Trial of Microtia Patients
- ClinicalTrials.gov ID
- NCT06118216
- Acronym / sponsor ID
- CCDPDAMIAW
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Xiaohui SuUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-PCIA | Placebo comparator | Procedure: intravenous patient-controlled anesthesia |
| Group-IA+PCIA | Experimental | Procedure: rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia, Procedure: intravenous patient-controlled anesthesia |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesiaAfter 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 or surgery | Group-IA+PCIA |
| intravenous patient-controlled anesthesiaAfter 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). | Procedure or surgery | Group-IA+PCIA, Group-PCIA |
Primary outcome
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.
1 secondary outcome
Barthel's index
Time frame: 24hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Background: PubMed 27350268Niiyama 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.
- Background: PubMed 27430605Woo 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.
- Background: PubMed 26908556Shaffer 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.
- Derived from this study: PubMed 39342766Wei S, Ye J, Lei C, Huang Q, Lin B, Su X, Zheng H, Shan X, Wang B, Wang M. Abdominal muscles infiltration analgesia for donor-site pain in autologous ear reconstruction: A randomized controlled clinical trial. J Plast Reconstr Aesthet Surg. 2024 Dec;99:38-46. doi: 10.1016/j.bjps.2024.09.019. Epub 2024 Sep 20.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rectus abdominis(RAM) and external oblique muscle(EOM) infiltration analgesia in people with Rectus Abdominis and External Oblique Muscle Infiltration Analgesia, run by Xiaohui Su at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numeric rating scale (time frame: 4,8,12,16,20,24,28,32,36,40,44,48hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118216, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.