Pain, PostoperativePhase 4UGRSBNCT02115087
Efficacy Study of Rectus Sheath Block to Control Postoperative Pain
A Phase 4 study testing ultrasound guided rectus sheath block and Morphine in people with Pain, Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- ultrasound guided rectus sheath block and Morphine
- 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
- Sep 2010to Jan 2011
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status I-II
- 3-15 years of age children
- Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision
Who cannot join
- ASA physical status III and above
- Parents who did not consider to participate in the study
- Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Department of Anesthesiology, Cukurova University Faculty of Medicine
Adana, 01130
About this study
Official title: The Effect of Ultrasound Guided Rectus Sheath Block on Postoperative Analgesia After Laparotomy With Transverse Incision in Children
The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.
Read the detailed description
Prospective, randomized study.Forty patients with American Society of Anaesthesiologists (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups and are administered general anesthesia and before the beginning of surgery ultrasound guided RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M, respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of morphine and 30 minutes lockout interval is set up postoperatively in both groups.
- Conditions
- Pain, Postoperative
- Being tested
- ultrasound guided rectus sheath block, Morphine
- Keywords
- laparotomy, levobupivacaine, patient controlled analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided rectus sheath blockProcedure or surgery
Also called US guided rectus sheath block
the application of rectus sheath block with ultrasound guidance
MorphineDrug
| Study group | Role | What they receive |
|---|---|---|
| ultrasound guided rectus sheath block | Experimental | Ultrasound guided rectus sheath block Receives: Procedure: ultrasound guided rectus sheath block |
| iv morphine | Active comparator | 0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the FLACC scale
FLACC scale has been used to measure postoperative pain level in children
Measured: Twenty-four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startSep 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ersel GULEC, Cukurova University
- Investigators
- Dilek Ozcengiz, Prof., Principal investigator, Department of Anesthesiology, Cukurova University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115087
- Sponsor's protocol ID
- UGRSB-123
- Acronym
- UGRSB
- Status last verified
- Apr 2014
- First submitted
- 9 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005.
PubMed 21377070
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ultrasound Guided Rectus Sheath Block on Postoperative Analgesia After Laparotomy With Transverse Incision in Children
- ClinicalTrials.gov ID
- NCT02115087
- Acronym / sponsor ID
- UGRSB / UGRSB-123
- Conditions
- Pain, Postoperative
- Keywords
- laparotomy, levobupivacaine, patient controlled analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 15 Apr 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.
The aim of this study is to evaluate the effect of the ultrasound guided rectus sheath block (RSB) on both intraoperative sevoflurane consumption and postoperative analgesia.
Detailed description
Prospective, randomized study.Forty patients with American Society of Anaesthesiologists (ASA) I-II physical status, aged 3-15 years.Patients are randomly allocated into two groups and are administered general anesthesia and before the beginning of surgery ultrasound guided RSB with 0.2 ml.kg-1, 0.25% of levobupivacaine and thirty minutes before the surgery the loading dose of morphine of 0.1 mg.kg-1 intravenously are received in group RSB and group M, respectively. Patient controlled analgesia (PCA) device with 0.01 mg.kg-1 bolus dose of morphine and 30 minutes lockout interval is set up postoperatively in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound guided rectus sheath block | Experimental | Procedure: ultrasound guided rectus sheath blockUltrasound guided rectus sheath block |
| iv morphine | Active comparator | Drug: Morphine0.1 mg.kg-1 loading dose of morphine by intravenous route in intraoperative period |
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status I-II
- 3-15 years of age children
- Abdominal surgery including liver, gall bladder, spleen, small intestine, cecum, colon, rectum, intra-abdominal masses, umbilical, paraumbilical, and inguinal hernia with transverse incision
Key exclusion criteria (3 listed)
- ASA physical status III and above
- Parents who did not consider to participate in the study
- Having systemic (septicemia, bacteremia) or local infection, bleeding and shock, predisposition for bleeding and anticoagulant therapy given, central nervous system disease, allergy to local anesthetics, severe respiratory, hepatic, and renal failure
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 |
|---|---|---|
| ultrasound guided rectus sheath blockAlso: US guided rectus sheath blockthe application of rectus sheath block with ultrasound guidance | Procedure or surgery | ultrasound guided rectus sheath block |
| Morphine | Drug | iv morphine |
Primary outcome
Pain Scores on the FLACC scale
Time frame: Twenty-four hours
FLACC scale has been used to measure postoperative pain level in children
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 15 Apr 2014.
- Background: PubMed 21377070Gelfand HJ, Ouanes JP, Lesley MR, Ko PS, Murphy JD, Sumida SM, Isaac GR, Kumar K, Wu CL. Analgesic efficacy of ultrasound-guided regional anesthesia: a meta-analysis. J Clin Anesth. 2011 Mar;23(2):90-6. doi: 10.1016/j.jclinane.2010.12.005.
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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, Prof. principal investigator
Department of Anesthesiology, Cukurova University Faculty of Medicine
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 ultrasound guided rectus sheath block and Morphine in people with Pain, Postoperative, 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 3 inclusion and 3 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 15 Apr 2014. 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 on the FLACC scale (time frame: Twenty-four 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 NCT02115087, which also lists 1 linked publication.
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 15 Apr 2014.