Postoperative PainNCT03781687
Bilateral vs. Unilateral Erector Spinae Plane Block
A study testing Bilateral ESP Block and Unilateral ESP Block in people with Postoperative Pain and Cholecystitis; Gallstone, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain, Cholecystitis; Gallstone
- What is being tested?
- Bilateral ESP Block and Unilateral ESP Block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 29 Jun 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-II patients
- Pateints undergoing elective laparoscopic cholecystectomy
Who cannot join
- obesity (body mass index >35 kg/m2)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kocaeli University Hospital
İzmit, Kocaeli, 41340
About this study
Official title: Bilateral vs. Unilateral Erector Spinae Plane Block for Laparoscopic Cholecystectomy; A Randomised Controlled Trial
The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.
- Conditions
- Postoperative Pain, Cholecystitis; Gallstone
- Being tested
- Bilateral ESP Block, Unilateral ESP Block, Intravenous Morphine patient controlled analgesia device
- Keywords
- erector spinae plane block, postoperative pain, laparoscopic cholecystectomy
- Medical subject headings
- Pain, Postoperative, Cholecystitis, Gallstones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral ESP BlockProcedure or surgery
Bilateral ESP Block will be performed at T8
Unilateral ESP BlockProcedure or surgery
Unilateral ESP Block will be performed at T8 (right side)
Intravenous Morphine patient controlled analgesia deviceDevice
24 hour morphine consumption will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Bilateral | Active comparator | Bilateral ESP block will be performed Receives: Procedure: Bilateral ESP Block; Device: Intravenous Morphine patient controlled analgesia device |
| Unilateral | Active comparator | Unilateral ESP block will be performed Receives: Procedure: Unilateral ESP Block; Device: Intravenous Morphine patient controlled analgesia device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Morphine consumption will be recorded
Measured: preoperative 24th hour
Secondary outcomes (1)
Numeric Rating Scale
A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.
Measured: postoperative 24th hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start2 Jan 2019
- Primary completion28 Jun 2019
- Study completion29 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can AKSU, Kocaeli University
- Investigators
- Can Aksu, Principal investigator, Kocaeli Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781687
- Sponsor's protocol ID
- KIA 2018/488
- Status last verified
- Nov 2019
- First submitted
- 18 Dec 2018
- Last updated
- 25 Nov 2019
- 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 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bilateral vs. Unilateral Erector Spinae Plane Block for Laparoscopic Cholecystectomy; A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03781687
- Acronym / sponsor ID
- KIA 2018/488
- Conditions
- Postoperative Pain, Cholecystitis; Gallstone
- Keywords
- erector spinae plane block, postoperative pain, laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 28 Jun 2019 (actual)
- Study completion
- 29 Jun 2019 (actual)
- First posted
- 20 Dec 2018 (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.
The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bilateral | Active comparator | Procedure: Bilateral ESP Block, Device: Intravenous Morphine patient controlled analgesia deviceBilateral ESP block will be performed |
| Unilateral | Active comparator | Procedure: Unilateral ESP Block, Device: Intravenous Morphine patient controlled analgesia deviceUnilateral ESP block will be performed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II patients
- Pateints undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (5 listed)
- obesity (body mass index >35 kg/m2)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs
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 |
|---|---|---|
| Bilateral ESP BlockBilateral ESP Block will be performed at T8 | Procedure or surgery | Bilateral |
| Unilateral ESP BlockUnilateral ESP Block will be performed at T8 (right side) | Procedure or surgery | Unilateral |
| Intravenous Morphine patient controlled analgesia device24 hour morphine consumption will be recorded | Device | Bilateral, Unilateral |
Primary outcome
Morphine consumption
Time frame: preoperative 24th hour
Morphine consumption will be recorded
1 secondary outcome
Numeric Rating Scale
Time frame: postoperative 24th hour
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 25 Nov 2019.
- 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.
Can Aksu principal investigator
Kocaeli Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral ESP Block and Unilateral ESP Block in people with Postoperative Pain and Cholecystitis; Gallstone, run by Kocaeli 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 5 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 25 Nov 2019. 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?
Morphine consumption (time frame: preoperative 24th hour). 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 25 Nov 2019; AzTrials last refreshed its copy on 31 Oct 2026.