Postoperative Pain, AcuteNCT05225766
Comparison of Erector Spinae Plane Block and Rectus Sheath Block
A study testing bupivacaine in people with Postoperative Pain, Acute, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Feb 2021to 9 Sep 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years
- American Society of Anesthesiologists (ASA) classes I-III
Who cannot join
- Local anesthetic allergy
- Coagulopathy
- Injection site infection
- History of abdominal surgery
- Severe neurological or psychiatric disorder
- Severe cardiovascular disease, liver failure, renal failure (glomerular filtration rate <15 ml/min/1.73 m2)
- chronic opioid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intraoperative and Postoperative Effects of Erector Spinae Plane Block and Rectus Sheath Block
In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.
Read the detailed description
Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.
- Conditions
- Postoperative Pain, Acute
- Being tested
- bupivacaine
- Keywords
- erector spinae plane block, rectus sheath block, pain management, midline laparotomy
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineOther
used for peripheral block
| Study group | Role | What they receive |
|---|---|---|
| Group ESPB | Active comparator | Erector spinae plane block Receives: Other: bupivacaine |
| Group RSB | Active comparator | Rectus sheath block Receives: Other: bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative hemodynamic data and administered opioid doses
Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.
Measured: 150 minutes
postoperative visual analog scales at rest and during coughing
Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.
Measured: 48 hours
time to first patient controlled analgesia (PCA) dose
The times when patients used the PCA device for the first time were recorded and compared between groups.
Measured: 48 hours
postoperative morphine consumption
Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.
Measured: 48 hours
need for rescue analgesics
Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration.
Measured: 48 hours
duration time until first mobilization
The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.
Measured: 48 hours
opioid side effects
Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.
Measured: 48 hours
patient and surgeon satisfaction
Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start25 Feb 2021
- Primary completion11 Aug 2021
- Study completion9 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Salman, Uludag University
- Investigators
- Emre SALMAN, MD, Principal investigator, Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225766
- Sponsor's protocol ID
- TurkishARD
- Status last verified
- Feb 2022
- First submitted
- 8 Nov 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraoperative and Postoperative Effects of Erector Spinae Plane Block and Rectus Sheath Block
- ClinicalTrials.gov ID
- NCT05225766
- Acronym / sponsor ID
- TurkishARD
- Conditions
- Postoperative Pain, Acute
- Keywords
- erector spinae plane block, rectus sheath block, pain management, midline laparotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 11 Aug 2021 (actual)
- Study completion
- 9 Sep 2021 (actual)
- First posted
- 7 Feb 2022 (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.
In study, The investigators aimed to compare the intraoperative and postoperative analgesic efficacy of erector spinae plane block and rectus sheath block, which investigators routinely perform in surgeries with abdominal lover midline-upper midline incision, morphine consumption with patient-controlled analgesia, as well as patient and surgeon satisfaction.
Detailed description
Following ethics committee approval and written consent from the patients, the study was conducted on 60 patients aged between 18-75 years in American Society of Anesthesiologists (ASA) classes I-III, who were to undergo midline incisions. The demographic data of the patients were recorded and after routine monitoring and general anesthesia induction, they were divided into two groups as the ESPB group and RSB group. Hemodynamic data of all patients were recorded before induction, one minute after induction, and intraoperatively in 30-minute periods. Patient-controlled analgesia (PCA) prepared with morphine was administered to all patients. Patients' intraoperative hemodynamic data and administered opioid doses, postoperative visual analog scales (VAS) at rest and during coughing, time to first PCA dose, postoperative morphine consumption, need for rescue analgesics, duration time until first mobilization, opioid side effects, and patient and surgeon satisfaction were evaluated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group ESPB | Active comparator | Other: bupivacaineErector spinae plane block |
| Group RSB | Active comparator | Other: bupivacaineRectus sheath block |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged 18-75 years
- American Society of Anesthesiologists (ASA) classes I-III
Key exclusion criteria (7 listed)
- Local anesthetic allergy
- Coagulopathy
- Injection site infection
- History of abdominal surgery
- Severe neurological or psychiatric disorder
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 |
|---|---|---|
| bupivacaineused for peripheral block | Other | Group ESPB, Group RSB |
Primary outcome
intraoperative hemodynamic data and administered opioid doses
Time frame: 150 minutes
Intraoperative hemodynamic values (peripheric oxigen saturation, mean arterial pressure, heart rate) of the patients and intraoperative opioid consumption (mg) were compared.
postoperative visual analog scales at rest and during coughing
Time frame: 48 hours
Postoperatively, both coughing and resting visual analog scale values (A rating between 0 and 10 was made. 0 no pain 10 severe pain) of the patients were recorded and compared between the groups.
time to first patient controlled analgesia (PCA) dose
Time frame: 48 hours
The times when patients used the PCA device for the first time were recorded and compared between groups.
postoperative morphine consumption
Time frame: 48 hours
Total morphine (mg) consumptions used with postoperative PCA were recorded and compared between groups.
need for rescue analgesics
Time frame: 48 hours
Bolus-dose morphine administration was provided to patients with VAS ≥4 upon questioning in the clinic or in line with patients' complaints, and patients' VAS scores during the first use of PCA were recorded. It was planned for rescue analgesic to be administered in patients with VAS ≥4 despite PCA, firstly as 20 mg IV tenoxicam (Tilcotil®, Deva, Tekirdağ, Turkey), and secondly as 50 mg IV tramadol (Tramosel®, Haver, Istanbul, Turkey) if VAS was still ≥4 one hour after tenoxicam administration.
duration time until first mobilization
Time frame: 48 hours
The times until the first mobilization of the patients were recorded and it was investigated whether there was a difference between the groups in terms of mobilization times.
opioid side effects
Time frame: 48 hours
Side effects (nausea, vomiting and sedation) that may occur due to opioid use in patients were recorded. And it was investigated whether there was a difference between the groups.
patient and surgeon satisfaction
Time frame: 48 hours
Patient and surgical team satisfaction were recorded using a 5-point Likert scale (A rating of 1 to 5 was requested. 1- not at all satisfied 2- somewhat satisfied 3- undecided 4- satisfied 5- very satisfied).The difference between the groups was investigated.
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 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Emre SALMAN, MD principal investigator
Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine in people with Postoperative Pain, Acute, run by Uludag 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 2 inclusion and 7 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 Feb 2022. 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.
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?
intraoperative hemodynamic data and administered opioid doses (time frame: 150 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2022.