Postoperative PainPhase 4NCT02291705
Ultrasound-guided Rectus Sheath Block In Children
A Phase 4 study testing rectus sheath block and Tramadol in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia. Read more about this study
- Who is it for?
- Ages 2 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- rectus sheath block and Tramadol
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2012to Nov 2014
- Phase
- Phase 4
- 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 2 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The children aged 2-7 years scheduled for inguinal hernia repair
Who cannot join
- American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.
Trial locations and contacts
1 site in 1 country.
About this study
Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia.
Read the detailed description
After approval the faculty ethical committee and informed consent from the parents (legal guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in this prospective, randomized study. The patients were divided into two groups. After induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T before closure of the fascia. Intraoperative and postoperative hemodynamic parametres, postoperative pain by means of the FLACC were evaluated.
Primary end point was pain score using FLACC scale.
- Conditions
- Postoperative Pain
- Being tested
- rectus sheath block, Tramadol
- Keywords
- Ultrasound, rectus sheath block, children, inguinal hernia
- Medical subject headings
- Pain, Postoperative, Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectus sheath blockProcedure or surgery
ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine
TramadolDrug
tramadol 1 mg/kg iv
| Study group | Role | What they receive |
|---|---|---|
| rectus sheath block | Experimental | rectus sheath block Receives: Procedure: rectus sheath block |
| tramadol | Active comparator | tramadol control group Receives: Drug: Tramadol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2014 (estimated)
- Study startJan 2012
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mediha turktan, Cukurova University
- Investigators
- dilek ozcengiz, MD, Study director, CUKUROVA UNİVERSİTY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02291705
- Sponsor's protocol ID
- USG12
- Status last verified
- May 2023
- First submitted
- 7 Nov 2014
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Breschan C, Jost R, Stettner H, Feigl G, Semmelrock S, Graf G, Likar R. Ultrasound-guided rectus sheath block for pyloromyotomy in infants: a retrospective analysis of a case series. Paediatr Anaesth. 2013 Dec;23(12):1199-204. doi: 10.1111/pan.12267. Epub 2013 Sep 25.
PubMed 24112798Flack SH, Martin LD, Walker BJ, Bosenberg AT, Helmers LD, Goldin AB, Haberkern CM. Ultrasound-guided rectus sheath block or wound infiltration in children: a randomized blinded study of analgesia and bupivacaine absorption. Paediatr Anaesth. 2014 Sep;24(9):968-73. doi: 10.1111/pan.12438. Epub 2014 May 22.
PubMed 24853314Alsaeed AH, Thallaj A, Khalil N, Almutaq N, Aljazaeri A. Ultrasound-guided rectus sheath block in children with umbilical hernia: Case series. Saudi J Anaesth. 2013 Oct;7(4):432-5. doi: 10.4103/1658-354X.121079.
PubMed 24348296
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Rectus Sheath Block In Children
- ClinicalTrials.gov ID
- NCT02291705
- Acronym / sponsor ID
- USG12
- Conditions
- Postoperative Pain
- Keywords
- Ultrasound, rectus sheath block, children, inguinal hernia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 14 Nov 2014 (estimated)
- 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.
Inguinal hernia repair is one of the common day-case surgery in children. The aim of this study is to compare the effects of ultrasound guided rectus sheath block and intravenous tramadol on peroperative anesthetic requirement and postoperative analgesia.
Detailed description
After approval the faculty ethical committee and informed consent from the parents (legal guardian) forty children aged 2-7 years scheduled for inguinal hernia repair were included in this prospective, randomized study. The patients were divided into two groups. After induction of general anesthesia, ultrasound guided rectus sheath block was applied to Group R with 0.2 mL/kg levobupivacain 0.25%. Tramadol 1 mg/kg intravenously was given to Group T before closure of the fascia. Intraoperative and postoperative hemodynamic parametres, postoperative pain by means of the FLACC were evaluated.
Primary end point was pain score using FLACC scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rectus sheath block | Experimental | Procedure: rectus sheath blockrectus sheath block |
| tramadol | Active comparator | Drug: Tramadoltramadol control group |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The children aged 2-7 years scheduled for inguinal hernia repair
Key exclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) classification III or greater, history of long term analgesic use, use of any analgesic within 24 hours before surgery, bleeding disorder, infection of application area, ultrasound imaging was inadequate and inability of the FLACC pain scoring system, substance sensitivity to local anesthetics.
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 sheath blockultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine | Procedure or surgery | rectus sheath block |
| Tramadoltramadol 1 mg/kg iv | Drug | tramadol |
Primary outcome
Pain Scores
Time frame: postoperative 24 hours
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 1 Jun 2023.
- Background: PubMed 24112798Breschan C, Jost R, Stettner H, Feigl G, Semmelrock S, Graf G, Likar R. Ultrasound-guided rectus sheath block for pyloromyotomy in infants: a retrospective analysis of a case series. Paediatr Anaesth. 2013 Dec;23(12):1199-204. doi: 10.1111/pan.12267. Epub 2013 Sep 25.
- Background: PubMed 24853314Flack SH, Martin LD, Walker BJ, Bosenberg AT, Helmers LD, Goldin AB, Haberkern CM. Ultrasound-guided rectus sheath block or wound infiltration in children: a randomized blinded study of analgesia and bupivacaine absorption. Paediatr Anaesth. 2014 Sep;24(9):968-73. doi: 10.1111/pan.12438. Epub 2014 May 22.
- Background: PubMed 24348296Alsaeed AH, Thallaj A, Khalil N, Almutaq N, Aljazaeri A. Ultrasound-guided rectus sheath block in children with umbilical hernia: Case series. Saudi J Anaesth. 2013 Oct;7(4):432-5. doi: 10.4103/1658-354X.121079.
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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.
dilek ozcengiz, MD study director
CUKUROVA UNİVERSİTY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rectus sheath block and Tramadol in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
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 1 Jun 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain Scores (time frame: postoperative 24 hours). 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 NCT02291705, which also lists 3 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 1 Jun 2023.