UltrasoundNCT06640062
Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy
A study testing Erector spinae plane block and Oblique subcostal transversus abdominis plane block in people with Ultrasound and Erector Spinae Plane Block, run by Helwan University at 1 site in Egypt.
Trial summary
The aim of this work was to compare the effect of using oblique subcostal transversus abdominis plane (OSTAP) block and erector spinae plane (ESP) block as a part of multi-modal analgesia technique in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Ultrasound, Erector Spinae Plane Block, Oblique Subcostal Transversus Abdominis Plane Block
- What is being tested?
- Erector spinae plane block and Oblique subcostal transversus abdominis plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Sep 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 20 to 60 years.
- Both gender.
- American Society of Anesthesiologists (ASA) grade I and II physical status.
- Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
- Underwent laparoscopic cholecystectomy.
Who cannot join
- Patient refusal.
- Known sensitivity or contraindication to drugs used in the study (local anesthetics, opioids).
- History of psychological disorders and/or chronic pain syndrome.
- Contraindication to regional anesthesia, e.g., local sepsis, pre-existing peripheral neuropathies, and coagulopathy.
- Severe respiratory disorders such as (severe obstructive pulmonary disease, forced expiratory volume (FEV1), forced vital capacity (FVC) <50% or severe restrictive pulmonary disease, and adult respiratory distress syndrome).
- Severe cardiac disorders such as (heart failure).
Show all 9Show fewer
- Advanced liver disease (elevated liver enzymes more than 3 folds of normal range).
- Advanced kidney disease (Decreased creatinine clearance <40 ml/min).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Comparative Study
The aim of this work was to compare the effect of using oblique subcostal transversus abdominis plane (OSTAP) block and erector spinae plane (ESP) block as a part of multi-modal analgesia technique in patients undergoing laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy is a commonly performed surgery and requires multi-modal analgesia for better control of pain. Untreated post-operative pain has many consequences, including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, and increased healthcare costs.
Many inter-fascial plane blocks like oblique subcostal transversus abdominis plane (OSTAP) block and recently, erector spinae plane (ESP) block have been utilized as a part of multi modal analgesia technique in many abdominal surgeries.
- Conditions
- Ultrasound, Erector Spinae Plane Block, Oblique Subcostal Transversus Abdominis Plane Block, Laparoscopic Cholecystectomy
- Being tested
- Erector spinae plane block, Oblique subcostal transversus abdominis plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector spinae plane blockOther
Patients received ultrasound-guided erector spinae plane block.
Oblique subcostal transversus abdominis plane blockOther
Patients received ultrasound-guided oblique subcostal transversus abdominis plane block.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block group | Active comparator | Patients received ultrasound-guided erector spinae plane block. Receives: Other: Erector spinae plane block |
| Oblique subcostal transversus abdominis plane block group | Experimental | Patients received ultrasound-guided oblique subcostal transversus abdominis plane block. Receives: Other: Oblique subcostal transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of pain intensity
The degree of pain intensity was assessed using the Visual Analogue Scale (VAS). Each patient was instructed about postoperative pain assessment with the VAS. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). It was assessed at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Time to first rescue analgesia
Time to first rescue analgesia was assessed from the end of surgery to the first dose of morphine administrated
Measured: 24 hours postoperatively
Total amount of morphine consumption
When a patient complains of pain equivalent to the Visual Analogue Scale (VAS) ≥ 3, rescue analgesia is given in the form of morphine (0.05mg/kg) intravenous increments, as needed.
Measured: 24 hours postoperatively
Morphine-related side effects
Morphine-related side effects such as incidence of nausea and vomiting, respiratory depression (respiratory rate < 8 breaths/min), bradycardia (heart rate decreases by > 20% of basal reading), pruritus, and urine retention were recorded.
Measured: 24 hours postoperatively
Local anesthetics-related side effects
Local anesthetics-related side effects such as lightheadedness, circumoral numbness, tongue paresthesia, drowsiness, irritability, muscle twitches, convulsions, bradycardia, hypotension (mean arterial blood pressure decreases by > 20% of basal reading), hypoventilation and cardiac arrest were recorded.
Measured: 24 hours postoperatively
Incidence of adverse effects of the block technique
Signs of adverse effects of the block techniques, such as local site infection, hematoma formation, bowel perforation, or pneumothorax, were recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasoundStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Fayez Yousef Metias, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640062
- Sponsor's protocol ID
- 118-2022
- Status last verified
- Oct 2024
- First submitted
- 10 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Comparative Study
- ClinicalTrials.gov ID
- NCT06640062
- Acronym / sponsor ID
- 118-2022
- Conditions
- Ultrasound, Erector Spinae Plane Block, Oblique Subcostal Transversus Abdominis Plane Block, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 15 Oct 2024 (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 aim of this work was to compare the effect of using oblique subcostal transversus abdominis plane (OSTAP) block and erector spinae plane (ESP) block as a part of multi-modal analgesia technique in patients undergoing laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy is a commonly performed surgery and requires multi-modal analgesia for better control of pain. Untreated post-operative pain has many consequences, including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, and increased healthcare costs.
Many inter-fascial plane blocks like oblique subcostal transversus abdominis plane (OSTAP) block and recently, erector spinae plane (ESP) block have been utilized as a part of multi modal analgesia technique in many abdominal surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block group | Active comparator | Other: Erector spinae plane blockPatients received ultrasound-guided erector spinae plane block. |
| Oblique subcostal transversus abdominis plane block group | Experimental | Other: Oblique subcostal transversus abdominis plane blockPatients received ultrasound-guided oblique subcostal transversus abdominis plane block. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 20 to 60 years.
- Both gender.
- American Society of Anesthesiologists (ASA) grade I and II physical status.
- Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
- Underwent laparoscopic cholecystectomy.
Key exclusion criteria (9 listed)
- Patient refusal.
- Known sensitivity or contraindication to drugs used in the study (local anesthetics, opioids).
- History of psychological disorders and/or chronic pain syndrome.
- Contraindication to regional anesthesia, e.g., local sepsis, pre-existing peripheral neuropathies, and coagulopathy.
- Severe respiratory disorders such as (severe obstructive pulmonary disease, forced expiratory volume (FEV1), forced vital capacity (FVC) <50% or severe restrictive pulmonary disease, and adult respiratory distress syndrome).
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 blockPatients received ultrasound-guided erector spinae plane block. | Other | Erector spinae plane block group |
| Oblique subcostal transversus abdominis plane blockPatients received ultrasound-guided oblique subcostal transversus abdominis plane block. | Other | Oblique subcostal transversus abdominis plane block group |
Primary outcome
Degree of pain intensity
Time frame: 24 hours postoperatively
The degree of pain intensity was assessed using the Visual Analogue Scale (VAS). Each patient was instructed about postoperative pain assessment with the VAS. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). It was assessed at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.
5 secondary outcomes
Time to first rescue analgesia
Time frame: 24 hours postoperatively
Total amount of morphine consumption
Time frame: 24 hours postoperatively
Morphine-related side effects
Time frame: 24 hours postoperatively
Local anesthetics-related side effects
Time frame: 24 hours postoperatively
Incidence of adverse effects of the block technique
Time frame: 24 hours postoperatively
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 Oct 2024.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Ultrasound
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
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 and Oblique subcostal transversus abdominis plane block in people with Ultrasound and Erector Spinae Plane Block, run by Helwan University at 1 site in Egypt.
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 5 inclusion and 9 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 Oct 2024. 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 Egypt. 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?
Degree of pain intensity (time frame: 24 hours postoperatively). 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 Oct 2024.