UltrasoundNCT06654635
Ultrasound Guided Rhomboid Intercostal Plane Block Versus Thoracic Erector Spinae Plane Block in Upper Abdominal Surgery
A study testing Rhomboid intercostal plane block and Erector spinae plane block in people with Ultrasound and Rhomboid Intercostal Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of the work is to evaluate the analgesic efficacy of ultrasound guided rhomboid intercostal plane block versus ultrasound guided thoracic erector spinae block in patients undergoing upper abdominal surgery. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Ultrasound, Rhomboid Intercostal Plane Block, Thoracic Erector Spinae Plane Block
- What is being tested?
- Rhomboid intercostal plane block and Erector spinae plane block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 May 2025
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 21-65 years.
- Both gender.
- American Society of Anesthesiologists (ASA) classification I-II.
- Presented for elective upper abdominal surgery.
Who cannot join
- Patients refused to participate.
- Patients with known or suspected allergy to the used medication.
- Patients with preoperative chronic pain.
- Patients with major cardiac, renal, respiratory, or hepatic disease.
- Patients with potential risk of coagulopathy.
- Obese patients with body mass index (BMI) >35.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Omima M Eldeeb, Master, 01004584669, omima.eldeeb@med.tanta.edu.eg
Ayman A Yousef, MD
About this study
Official title: Comparison Between Ultrasound Guided Rhomboid Intercostal Plane Block and Thoracic Erector Spinae Plane Block in Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Trial
The aim of the work is to evaluate the analgesic efficacy of ultrasound guided rhomboid intercostal plane block versus ultrasound guided thoracic erector spinae block in patients undergoing upper abdominal surgery.
Read the detailed description
Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period.
The improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decrease postoperative complications and an improved postoperative course .
- Conditions
- Ultrasound, Rhomboid Intercostal Plane Block, Thoracic Erector Spinae Plane Block, Upper Abdominal Surgery
- Being tested
- Rhomboid intercostal plane block, Erector spinae plane block, Control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhomboid intercostal plane blockDrug
The patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally.
Erector spinae plane blockOther
The patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. Erector spinae plane block will be performed at the level of T9 bilaterally.
Control groupOther
No block will be performed, and patient will receive general anesthesia (GA) only.
| Study group | Role | What they receive |
|---|---|---|
| Rhomboid intercostal plane block group | Experimental | The patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally. Receives: Drug: Rhomboid intercostal plane block |
| Erector spinae plane block group | Experimental | The patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. ESP block will be performed at the level of T9 bilaterally. Receives: Other: Erector spinae plane block |
| Control group | Experimental | No block will be performed, and patient will receive general anesthesia (GA) only. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates The visual analogue scale (VAS). ≥ 4 with maximum dose 20 mg for 24 hours. The total amount of morphine (mg) given will be recorded for the 3 groups.
Measured: 24 hours postoperatively
Secondary outcomes (5)
Degree of pain
Postoperative pain will be assessed by visual analogue scale (VAS) 30 min from admission to PACU, 2, 4, 6, 12, 18 and 24 h postoperative (0= no pain, 10= sever pain).
Measured: 24 hours postoperatively
Time to 1st request of rescue analgesia
Time to 1st request for the rescue of analgesia (time from the end of surgery till first dose of morphine administrated ) will be recorded.
Measured: 24 hours postoperatively
Heart rate
Heart rate will be measured preoperative, after induction, after receiving block and every 15 min till the end of surgery
Measured: Every 15 min till the end of surgery
Mean arterial blood pressure
Mean arterial blood pressure will be measured preoperative, after induction, after receiving block and every 15 min till the end of surgery
Measured: Every 15 min till the end of surgery
Incidence of side effects
Any undesirable adverse events will be treated and recorded (e.g., bradycardia, hypotension, pneumothorax, hematoma, nerve injury and nausea, vomiting, local anesthetic systemic toxicity (LAST), respiratory depression or any other complication).
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 posted23 Oct 2024
- Study start1 Jan 2024
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
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.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omima Mohammed Fakher Eldin Ali, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654635
- Sponsor's protocol ID
- 36264MD87/5/23
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 23 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 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound Guided Rhomboid Intercostal Plane Block and Thoracic Erector Spinae Plane Block in Patients Undergoing Upper Abdominal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06654635
- Acronym / sponsor ID
- 36264MD87/5/23
- Conditions
- Ultrasound, Rhomboid Intercostal Plane Block, Thoracic Erector Spinae Plane Block, Upper Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 23 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 the work is to evaluate the analgesic efficacy of ultrasound guided rhomboid intercostal plane block versus ultrasound guided thoracic erector spinae block in patients undergoing upper abdominal surgery.
Detailed description
Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period.
The improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decrease postoperative complications and an improved postoperative course .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rhomboid intercostal plane block group | Experimental | Drug: Rhomboid intercostal plane blockThe patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally. |
| Erector spinae plane block group | Experimental | Other: Erector spinae plane blockThe patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. ESP block will be performed at the level of T9 bilaterally. |
| Control group | Experimental | Other: Control groupNo block will be performed, and patient will receive general anesthesia (GA) only. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 21-65 years.
- Both gender.
- American Society of Anesthesiologists (ASA) classification I-II.
- Presented for elective upper abdominal surgery.
Key exclusion criteria (6 listed)
- Patients refused to participate.
- Patients with known or suspected allergy to the used medication.
- Patients with preoperative chronic pain.
- Patients with major cardiac, renal, respiratory, or hepatic disease.
- Patients with potential risk of 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 |
|---|---|---|
| Rhomboid intercostal plane blockThe patients in this group will receive ultrasound -guided rhomboid intercostal plane block after induction of general anesthesia. The rhomboid intercostal block will be performed at the T6 levels, bilaterally. | Drug | Rhomboid intercostal plane block group |
| Erector spinae plane blockThe patients in this group will receive ultrasound -guided Erector spinae plane block after induction of general anesthesia. Erector spinae plane block will be performed at the level of T9 bilaterally. | Other | Erector spinae plane block group |
| Control groupNo block will be performed, and patient will receive general anesthesia (GA) only. | Other | Control group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Rescue analgesia will be provided in the form of IV morphine 3 mg boluses if the patient indicates The visual analogue scale (VAS). ≥ 4 with maximum dose 20 mg for 24 hours. The total amount of morphine (mg) given will be recorded for the 3 groups.
5 secondary outcomes
Degree of pain
Time frame: 24 hours postoperatively
Time to 1st request of rescue analgesia
Time frame: 24 hours postoperatively
Heart rate
Time frame: Every 15 min till the end of surgery
Mean arterial blood pressure
Time frame: Every 15 min till the end of surgery
Incidence of side effects
Time frame: 24 hours Postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 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.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rhomboid intercostal plane block and Erector spinae plane block in people with Ultrasound and Rhomboid Intercostal Plane Block, run by Tanta 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 4 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: status not confirmed, as of the sponsor's last update on 23 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omima M Eldeeb, Master (01004584669, omima.eldeeb@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (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 23 Oct 2024.