Postoperative PainNCT03420703
Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy
A study testing erector spinae plane block in people with Postoperative Pain, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- erector spinae plane block
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2018to 18 Apr 2018
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25 - 75 years of age
- ASA I - II
- Undergoing elective laparoscopic cholecystectomy
Who cannot join
- obesity
- ASA III - IV
- 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: The Effect of Erector Spinae Plane Block on Postoperative Pain Following Laparoscopic Cholecystectomy: A Randomized Controlled Study
Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.
- Conditions
- Postoperative Pain
- Being tested
- erector spinae plane block, Intravenous morphine patient controlled analgesia device
- Keywords
- erector spinae plane block, laparoscopic cholecystectomy, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinae plane blockOther
ultrasound guided erector spinae plane block will be administered to this group.
Intravenous morphine patient controlled analgesia deviceDevice
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
| Study group | Role | What they receive |
|---|---|---|
| Block group | Active comparator | Erector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively Receives: Other: erector spinae plane block; Device: Intravenous morphine patient controlled analgesia device |
| control group | Sham comparator | An intravenous patient controlled analgesia device will be given to the patients postoperatively Receives: Device: Intravenous morphine patient controlled analgesia device |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h morphine consumption
morphine consumptions for both group will be recorded
Measured: for postoperative 24 hour
Secondary outcomes (2)
Postoperative nausea and vomiting
PONV after surgery was questioned
Measured: 24 hour
Pain
Numeric rating scales were recorded
Measured: 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start24 Feb 2018
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Can AKSU, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420703
- Sponsor's protocol ID
- 2017-349
- Status last verified
- Jun 2018
- First submitted
- 29 Jan 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Erector Spinae Plane Block on Postoperative Pain Following Laparoscopic Cholecystectomy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03420703
- Acronym / sponsor ID
- 2017-349
- Conditions
- Postoperative Pain
- Keywords
- erector spinae plane block, laparoscopic cholecystectomy, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 24 Feb 2018 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 5 Feb 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.
Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block group | Active comparator | Other: erector spinae plane block, Device: Intravenous morphine patient controlled analgesia deviceErector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively |
| control group | Sham comparator | Device: Intravenous morphine patient controlled analgesia deviceAn intravenous patient controlled analgesia device will be given to the patients postoperatively |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25 - 75 years of age
- ASA I - II
- Undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- obesity
- ASA III - IV
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
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 |
|---|---|---|
| erector spinae plane blockultrasound guided erector spinae plane block will be administered to this group. | Other | Block group |
| Intravenous morphine patient controlled analgesia deviceIntravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded | Device | Block group, control group |
Primary outcome
24h morphine consumption
Time frame: for postoperative 24 hour
morphine consumptions for both group will be recorded
2 secondary outcomes
Postoperative nausea and vomiting
Time frame: 24 hour
Pain
Time frame: 24h
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 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
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 erector spinae plane block in people with Postoperative Pain, 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 3 inclusion and 6 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 Jun 2018. 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. 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?
24h morphine consumption (time frame: for postoperative 24 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 15 Jun 2018.