Regional Anesthesia MorbidityNCT05706233
Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy
An observational study of Regional Anesthesia Morbidity and Cholecystitis, Chronic, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy, one of the most commonly performed abdominal surgeries, is a gold standard therapy for surgical treatment of benign biliary diseases. Erector spinae plane block (ESPB) was first presented in 2016 as the treatment of neuropathic pain in a case series, and gained popularity very quickly due… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Regional Anesthesia Morbidity, Cholecystitis, Chronic
- What is being tested?
- Erector Spina Plane Group and IV analgesic intervention
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 108 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2022to 15 May 2022
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients undergoing laparoscopic cholecystectomy
Who may be able to join
- Patients undergoing laparoscopic cholecystectomy
- Patients with NRS>3 scores in the PACU
Who cannot join
- ASA > 2
- Violation of standart protocol (anesthesia and analgesia)
- application of ESPB preoperatively
- age > 65
- Surgery duration >90min or <45min
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Basaksehir Cam and Sakura City Hospital
Istanbul
About this study
Official title: Effect of Postoperative Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy: A Historical Cohort Study
Laparoscopic cholecystectomy, one of the most commonly performed abdominal surgeries, is a gold standard therapy for surgical treatment of benign biliary diseases.
Erector spinae plane block (ESPB) was first presented in 2016 as the treatment of neuropathic pain in a case series, and gained popularity very quickly due to its safety applicability, and effect on both the visceral and parietal component of pain by providing paravertebral, transforaminal and epidural spread. Preoperative application of ESPB has taken its place as a part of multimodal analgesia in laparoscopic cholecystectomy cases over time and has been shown to reduce postoperative pain scores and opioid consumption and to improve quality of recovery scores. However, there is no data regarding the use of ESPB in the postoperative period as a rescue therapy.
- Being tested
- Erector Spina Plane Group, IV analgesic intervention
- Medical subject headings
- Cholecystitis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spina Plane GroupProcedure or surgery
ESPB had been applied postoperatively: from T8 level, 20mL bupivacaine %0,5 + 5ml %2 lidocaine was applied.
IV analgesic interventionProcedure or surgery
IV analgesics had been applied: All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS > 3, 20 mg if NRS > 5, 30 mg if NRS > 8. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spina Plane Block (ESPB) | Not described Receives: Procedure: Erector Spina Plane Group | |
| Intravenous Group (IV) | Not described Receives: Procedure: IV analgesic intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of ESPB applied postoperatively on the meperidine consumption in PACU
As part of the standardized perioperative care management, the pain intensity is evaluated with the numeric pain rating scale (NRS). If the NRS is > 3 meperidine bolus or ESPB is applied in line with the patients' selection and the patients are evaluated in every 5 min in terms of their NRS scores until NRS < 4 is achieved. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied. All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS > 3, 20 mg if NRS > 5, 30 mg if NRS > 8. NRS scores and meperidine boluses applied are recorded on the PACU follow-up form.
Measured: 1 HOUR
Secondary outcomes (1)
effect of ESPB applied postoperatively on numeric rating scores in PACU
As part of the standardized perioperative care management, the pain intensity is evaluated with the numeric pain rating scale (NRS). If the NRS is > 3 meperidine bolus or ESPB is applied in line with the patients' selection and the patients are evaluated in every 5 min in terms of their NRS scores until NRS < 4 is achieved. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied. All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS > 3, 20 mg if NRS > 5, 30 mg if NRS > 8. NRS scores and meperidine boluses applied are recorded on the PACU follow-up form.
Measured: 1 HOUR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start15 Feb 2022
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706233
- Sponsor's protocol ID
- 2021.11.254
- Status last verified
- Jun 2023
- First submitted
- 9 Jan 2023
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Postoperative Erector Spinae Plane Block as a Rescue Pain Therapy in Patients Undergoing Laparoscopic Cholecystectomy: A Historical Cohort Study
- ClinicalTrials.gov ID
- NCT05706233
- Acronym / sponsor ID
- 2021.11.254
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 31 Jan 2023 (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.
Laparoscopic cholecystectomy, one of the most commonly performed abdominal surgeries, is a gold standard therapy for surgical treatment of benign biliary diseases.
Erector spinae plane block (ESPB) was first presented in 2016 as the treatment of neuropathic pain in a case series, and gained popularity very quickly due to its safety applicability, and effect on both the visceral and parietal component of pain by providing paravertebral, transforaminal and epidural spread. Preoperative application of ESPB has taken its place as a part of multimodal analgesia in laparoscopic cholecystectomy cases over time and has been shown to reduce postoperative pain scores and opioid consumption and to improve quality of recovery scores. However, there is no data regarding the use of ESPB in the postoperative period as a rescue therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spina Plane Block (ESPB) | – | Procedure: Erector Spina Plane Group |
| Intravenous Group (IV) | – | Procedure: IV analgesic intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing laparoscopic cholecystectomy
Key inclusion criteria (2 listed)
- Patients undergoing laparoscopic cholecystectomy
- Patients with NRS>3 scores in the PACU
Key exclusion criteria (5 listed)
- ASA > 2
- Violation of standart protocol (anesthesia and analgesia)
- application of ESPB preoperatively
- age > 65
- Surgery duration >90min or <45min
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 Spina Plane GroupESPB had been applied postoperatively: from T8 level, 20mL bupivacaine %0,5 + 5ml %2 lidocaine was applied. | Procedure or surgery | Erector Spina Plane Block (ESPB) |
| IV analgesic interventionIV analgesics had been applied: All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS > 3, 20 mg if NRS > 5, 30 mg if NRS > 8. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied. | Procedure or surgery | Intravenous Group (IV) |
Primary outcome
effect of ESPB applied postoperatively on the meperidine consumption in PACU
Time frame: 1 HOUR
As part of the standardized perioperative care management, the pain intensity is evaluated with the numeric pain rating scale (NRS). If the NRS is > 3 meperidine bolus or ESPB is applied in line with the patients' selection and the patients are evaluated in every 5 min in terms of their NRS scores until NRS < 4 is achieved. If NRS score is not reduced at least 20% when compared to prior one, additional meperidine bolus is applied. All meperidine boluses are dosed in line with the pain intensity as follows: 10 mg if NRS > 3, 20 mg if NRS > 5, 30 mg if NRS > 8. NRS scores and meperidine boluses applied are recorded on the PACU follow-up form.
1 secondary outcome
effect of ESPB applied postoperatively on numeric rating scores in PACU
Time frame: 1 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 28 Jun 2023.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Regional Anesthesia Morbidity and Cholecystitis, Chronic, run by Istanbul Saglik Bilimleri 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 28 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.
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?
effect of ESPB applied postoperatively on the meperidine consumption in PACU (time frame: 1 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 28 Jun 2023.