AnesthesiaPhase 3NCT06201364
External Oblique Intercostal Block Versus Paravertebral Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Patients
A Phase 3 study testing The external oblique intercostal block and Paravertebral block in people with Anesthesia, run by Assiut University.
Trial summary
To compare external oblique intercostal block versus paravertebral block for post operative analgesia in patients undergoing laparoscopic cholecystectomy to decease post operative opioid consumption and use the least dose of local anesthesia. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- The external oblique intercostal block and Paravertebral block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2024to 1 Aug 2025
- Phase
- Phase 3
- 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
- Patients between 20-60 years old
- Patients with ASA clinical status I\II
- Patients schedule for laparoscopic cholecystectomy
Who cannot join
- Patients refusal
- Coagulopathy
- Infection at site of injection
- Allergy of local anesthesia
- Sever cardiac disease
- Patients with chest wall deformities
Trial locations and contacts
No sites are listed yet.
About this study
To compare external oblique intercostal block versus paravertebral block for post operative analgesia in patients undergoing laparoscopic cholecystectomy to decease post operative opioid consumption and use the least dose of local anesthesia.
Read the detailed description
Paravertebral Block (PVB) involve injection of local anesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.
The external oblique intercostal block is a novel motor- and opioid-sparing technique which blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves which innervate the upper abdominal quadrant.
- Conditions
- Anesthesia
- Being tested
- The external oblique intercostal block, Paravertebral block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The external oblique intercostal blockProcedure or surgery
chest wall will be systematically scanned. Initially the probe will be placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle will be identified at the level ribs 6 and 7 in line with the xiphoid process to confirm correct identification of the external oblique muscle, the probe will be moved in the caudad direction following the external oblique muscle. At the subcostal level, the ultrasound probe will be rotated 90° to see the convergence with the internal oblique and transversus abdominus muscles. The probe will be then moved back to the initial identification point for the external oblique muscle. The EOI plane will be identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. Local anesthetic agent will be 20 ml volume (10 ml bupivacaine, 10 ml saline) will be injected under ultrasound guidance and this will be done bilaterally.
Paravertebral blockProcedure or surgery
involve injection of local anaesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anaesthetic technique for carrying out various procedures.
| Study group | Role | What they receive |
|---|---|---|
| EOI group | Experimental | chest wall will be systematically scanned. Initially the probe will be placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle will be identified at the level ribs 6 and 7 in line with the xiphoid process to confirm correct identification of the external oblique muscle, the probe will be moved in the caudad direction following the external oblique muscle. At the subcostal level, the ultrasound probe will be rotated 90° to see the convergence with the internal oblique and transversus abdominus muscles. The probe will be then moved back to the initial identification point for the external oblique muscle. The EOI plane will be identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. Local anesthetic agent will be 20 ml volume (10 ml bupivacaine 0.5% ,10ml saline) will be then injected, this procedure will be done bilaterally. Receives: Procedure: The external oblique intercostal block |
| PVB group | Active comparator | we will be scanning the anatomy of the lateral paravertebral space using a high-frequency linear ultrasound transducer, after identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique would be used to perform the PVB with 20 ml volume (10 ml bupivacaine 0.5% ,10ml saline) will be then injected, this procedure will be done bilaterally. Receives: Procedure: Paravertebral block |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine consumption
Measured: first 24 hours postoperatively
Secondary outcomes (2)
Time of first rescue analgesia
rescue analgesia will be given in the form of morphine 4 mg when VAS score ≥4
Measured: hours
Visual analogue scale (VAS)
It is a validated subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: at 0.5 ,1,2,4,8,12,24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2024
- Study start1 Feb 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Adel Abdelkareem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06201364
- Sponsor's protocol ID
- External oblique intercostal
- Status last verified
- Jan 2024
- First submitted
- 30 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- 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 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Oblique Intercostal Block Versus Paravertebral Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Patients
- ClinicalTrials.gov ID
- NCT06201364
- Acronym / sponsor ID
- External oblique intercostal
- Conditions
- Anesthesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 11 Jan 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.
To compare external oblique intercostal block versus paravertebral block for post operative analgesia in patients undergoing laparoscopic cholecystectomy to decease post operative opioid consumption and use the least dose of local anesthesia.
Detailed description
Paravertebral Block (PVB) involve injection of local anesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anesthetic technique for carrying out various procedures. This popularity is mainly due to the ease of the technique and fewer complications.
The external oblique intercostal block is a novel motor- and opioid-sparing technique which blocks both the anterior and lateral cutaneous branches of the thoracoabdominal nerves which innervate the upper abdominal quadrant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOI group | Experimental | Procedure: The external oblique intercostal blockchest wall will be systematically scanned. Initially the probe will be placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle will be identified at the level ribs 6 and 7 in line with the xiphoid process to confirm correct identification of the external oblique muscle, the probe will be moved in the caudad direction following the external oblique muscle. At the subcostal level, the ultrasound probe will be rotated 90° to see the convergence with the internal oblique and transversus abdominus muscles. The probe will be then moved back to the initial identification point for the external oblique muscle. The EOI plane will be identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. Local anesthetic agent will be 20 ml volume (10 ml bupivacaine 0.5% ,10ml saline) will be then injected, this procedure will be done bilaterally. |
| PVB group | Active comparator | Procedure: Paravertebral blockwe will be scanning the anatomy of the lateral paravertebral space using a high-frequency linear ultrasound transducer, after identification of the transverse process, internal intercostal membrane (IIM), and pleura at the T3 and T6 levels, an out-of-plane needle guidance technique would be used to perform the PVB with 20 ml volume (10 ml bupivacaine 0.5% ,10ml saline) will be then injected, this procedure will be done bilaterally. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between 20-60 years old
- Patients with ASA clinical status I\II
- Patients schedule for laparoscopic cholecystectomy
Key exclusion criteria (6 listed)
- Patients refusal
- Coagulopathy
- Infection at site of injection
- Allergy of local anesthesia
- Sever cardiac disease
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 |
|---|---|---|
| The external oblique intercostal blockchest wall will be systematically scanned. Initially the probe will be placed in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle will be identified at the level ribs 6 and 7 in line with the xiphoid process to confirm correct identification of the external oblique muscle, the probe will be moved in the caudad direction following the external oblique muscle. At the subcostal level, the ultrasound probe will be rotated 90° to see the convergence with the internal oblique and transversus abdominus muscles. The probe will be then moved back to the initial identification point for the external oblique muscle. The EOI plane will be identified deep to the external oblique muscle and superficial to the sixth and seventh ribs and their associated intercostal muscles. Local anesthetic agent will be 20 ml volume (10 ml bupivacaine, 10 ml saline) will be injected under ultrasound guidance and this will be done bilaterally. | Procedure or surgery | EOI group |
| Paravertebral blockinvolve injection of local anaesthetic in a space immediately lateral to where the spinal nerves emerge from the intervertebral foramina. This technique is being used increasingly for not only intra-operative and post-operative analgesia but also as a sole anaesthetic technique for carrying out various procedures. | Procedure or surgery | PVB group |
Primary outcome
total morphine consumption
Time frame: first 24 hours postoperatively
2 secondary outcomes
Time of first rescue analgesia
Time frame: hours
Visual analogue scale (VAS)
Time frame: at 0.5 ,1,2,4,8,12,24 hours postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing The external oblique intercostal block and Paravertebral block in people with Anesthesia, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohamed A Abd-Elkareem, MD (01050727722, mohamedadelkareem@aun.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: first 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 12 Jan 2024.