Epigastric Hernia RepairNCT05516901
Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Epigastric Hernia
A study testing The erector spinae plane block group in people with Epigastric Hernia Repair and Erector Spinae Plane Block, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the efficacy of ultrasound guided erector Spinae plane block on postoperative pain score and diaphragmatic dysfunction in obese patients undergoing Epigastric hernia repair. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Epigastric Hernia Repair, Erector Spinae Plane Block, Post Operative Pain
- What is being tested?
- The erector spinae plane block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2021to 30 Jul 2022
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fifty obese patient BMI (30-40).
- Aged (21-65) years ASA (ІΙ and ΙΙІ)
- scheduled for elective Epigastric hernia repair
Who cannot join
- Patient refusal to continue the study.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patients with renal, hepatic, cardiac dysfunction, or spine deformities.
- Patients with cognitive disorders.
- Patients with chronic pulmonary disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Obese Patients Undergoing Epigastric Hernia Repair
The aim of this study is to assess the efficacy of ultrasound guided erector Spinae plane block on postoperative pain score and diaphragmatic dysfunction in obese patients undergoing Epigastric hernia repair.
Read the detailed description
Ventral hernia repair is an operation associated with significant postoperative pain. There is a lot of modalities of pain control including regional anesthesia, intravenous opioids, and non-opioid analgesics. Regional anesthesia is often helpful in improving respiratory function and analgesia.
The dysfunction of the respiratory muscles, especially the diaphragm, caused by the upper abdominal surgery is a major cause of postoperative pulmonary complications, such as atelectasis and pneumonia. Sonografic evaluation of diaphragm is an accepted qualitative method of assessing diaphragmatic motion.
The erector spinae plane block is a paraspinal fascial plane block in which local anesthetic is administered between the erector spinae muscle and the transverse processes, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves.
According to previous studies, erector spinae plane block provide lower postoperative pain score and decrease consumption of both postoperative and intraoperative analgesia for patients undergoing Epigastric hernia repair.
- Conditions
- Epigastric Hernia Repair, Erector Spinae Plane Block, Post Operative Pain, Diaphragmatic Dysfunction
- Being tested
- The erector spinae plane block group, Control group
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The erector spinae plane block groupProcedure or surgery
The probe should then slowly be moved laterally until the transverse process is visible. The 100 mm, 25-gauge needle should be inserted using an in-plane approach in the cephalad to caudal direction and advanced under ultrasound guidance towards the transverse process; once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given. The erector spinae muscle should be visualized, separating from the transverse process. After aspiration the local anesthetic (20 ml of 0.25% bupivacaine was injected. Technique was repeated on the other side.
Control groupProcedure or surgery
Patients in this group will receive general anesthesia alone.
| Study group | Role | What they receive |
|---|---|---|
| The erector spinae plane block group | Experimental | The erector spinae plane block group: Patients will receive general anesthesia plus bilateral ultrasound guided ESP block. Receives: Procedure: The erector spinae plane block group |
| Control group | Placebo comparator | Control group (group І): Patients will receive general anesthesia alone. Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Post-operative pain will be assessed by Numeric Rating Scale at recovery room till 24 hours and if NRS˃3 morphine 3 mg will be given, total analgesics required will be recorded.
Measured: 24 hours postoperatively.
Diaphragmatic dysfunction by physiological parameter
After recovery, patient laid in the supine position and diaphragm movements were recorded in the B-Mode and M-Mode. The probe was positioned between the midclavicular and anterior axillary lines, in the subcostal area, so that the ultrasound beam entered the posterior third of the right hemi diaphragm perpendicularly.
After correct visualization of the right hemidiaphragm by B-mode, M-mode is used to display the motion of the diaphragm. At the end of normal expiration the patient was instructed to inhale as deeply as possible. A fixed point at the edge of the image on the screen and the diaphragm margin at maximal inspiration and again at maximal expiration served as reference points between which measurements were made, with the average of three values being taken for both maximal inspiration and maximal expiration
Measured: 24 hours postoperatively.
Secondary outcomes (2)
Hypotension
defined as decrease blood pressure more than 20% of base line It was treated with rapid IV fluid infusion (100ml over 1 minutes) and bolus ephedrine 5-15 mg if needed.
Measured: 24 hours postoperatively
Bradycardia
Bradycardia (heart rate less than 60 beats /minute) was treated with atropine 0.01mg/ kg
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 posted26 Aug 2022
- Study start1 Jul 2021
- Primary completion15 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epigastric Hernia RepairStudies 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
- Model description
- Fifty obese patient BMI (30-40), aged (21-65) years ASA (ІΙ and ΙΙІ) and scheduled for elective Epigastric hernia repair were enrolled in the study.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ragab Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516901
- Sponsor's protocol ID
- 34579/3/21
- Status last verified
- Aug 2022
- First submitted
- 20 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Guided Erector Spinae Plane Block on Post-operative Pain and Diaphragmatic Dysfunction in Obese Patients Undergoing Epigastric Hernia Repair
- ClinicalTrials.gov ID
- NCT05516901
- Acronym / sponsor ID
- 34579/3/21
- Conditions
- Epigastric Hernia Repair, Erector Spinae Plane Block, Post Operative Pain, Diaphragmatic Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 15 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 26 Aug 2022 (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 study is to assess the efficacy of ultrasound guided erector Spinae plane block on postoperative pain score and diaphragmatic dysfunction in obese patients undergoing Epigastric hernia repair.
Detailed description
Ventral hernia repair is an operation associated with significant postoperative pain. There is a lot of modalities of pain control including regional anesthesia, intravenous opioids, and non-opioid analgesics. Regional anesthesia is often helpful in improving respiratory function and analgesia.
The dysfunction of the respiratory muscles, especially the diaphragm, caused by the upper abdominal surgery is a major cause of postoperative pulmonary complications, such as atelectasis and pneumonia. Sonografic evaluation of diaphragm is an accepted qualitative method of assessing diaphragmatic motion.
The erector spinae plane block is a paraspinal fascial plane block in which local anesthetic is administered between the erector spinae muscle and the transverse processes, blocking the dorsal and ventral rami of the thoracic and abdominal spinal nerves.
According to previous studies, erector spinae plane block provide lower postoperative pain score and decrease consumption of both postoperative and intraoperative analgesia for patients undergoing Epigastric hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Fifty obese patient BMI (30-40), aged (21-65) years ASA (ІΙ and ΙΙІ) and scheduled for elective Epigastric hernia repair were enrolled in the study.
| Arm | Type | Receives |
|---|---|---|
| The erector spinae plane block group | Experimental | Procedure: The erector spinae plane block groupThe erector spinae plane block group: Patients will receive general anesthesia plus bilateral ultrasound guided ESP block. |
| Control group | Placebo comparator | Procedure: Control groupControl group (group І): Patients will receive general anesthesia alone. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fifty obese patient BMI (30-40).
- Aged (21-65) years ASA (ІΙ and ΙΙІ)
- scheduled for elective Epigastric hernia repair
Key exclusion criteria (7 listed)
- Patient refusal to continue the study.
- History of allergy to local anesthetics.
- Local infection at the site of the block.
- Patients with bleeding and coagulation disorders.
- Patients with renal, hepatic, cardiac dysfunction, or spine deformities.
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 erector spinae plane block groupThe probe should then slowly be moved laterally until the transverse process is visible. The 100 mm, 25-gauge needle should be inserted using an in-plane approach in the cephalad to caudal direction and advanced under ultrasound guidance towards the transverse process; once the needle tip is below the erector spinae muscle, a small bolus of local anesthetic should be given. The erector spinae muscle should be visualized, separating from the transverse process. After aspiration the local anesthetic (20 ml of 0.25% bupivacaine was injected. Technique was repeated on the other side. | Procedure or surgery | The erector spinae plane block group |
| Control groupPatients in this group will receive general anesthesia alone. | Procedure or surgery | Control group |
Primary outcome
Post-operative pain
Time frame: 24 hours postoperatively.
Post-operative pain will be assessed by Numeric Rating Scale at recovery room till 24 hours and if NRS˃3 morphine 3 mg will be given, total analgesics required will be recorded.
Diaphragmatic dysfunction by physiological parameter
Time frame: 24 hours postoperatively.
After recovery, patient laid in the supine position and diaphragm movements were recorded in the B-Mode and M-Mode. The probe was positioned between the midclavicular and anterior axillary lines, in the subcostal area, so that the ultrasound beam entered the posterior third of the right hemi diaphragm perpendicularly. After correct visualization of the right hemidiaphragm by B-mode, M-mode is used to display the motion of the diaphragm. At the end of normal expiration the patient was instructed to inhale as deeply as possible. A fixed point at the edge of the image on the screen and the diaphragm margin at maximal inspiration and again at maximal expiration served as reference points between which measurements were made, with the average of three values being taken for both maximal inspiration and maximal expiration
2 secondary outcomes
Hypotension
Time frame: 24 hours postoperatively
Bradycardia
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 26 Aug 2022.
Related trials for Epigastric Hernia Repair
Recruiting
Evaluating the Efficacy of Suture Mesh vs. Planar Mesh in Ventral Hernia Treatment
Abdominal Wall Hernia, Umbilical Hernia Repair
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 The erector spinae plane block group in people with Epigastric Hernia Repair and Erector Spinae 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 3 inclusion and 7 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 26 Aug 2022. 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. 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?
Post-operative pain (time frame: 24 hours postoperatively.). The study lists 2 primary outcomes in all. 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 26 Aug 2022.