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The TAP block, first described by Rafi in 2001, is comprised of deposition of a local anesthetic into the anatomical plane between the internal oblique and transverses abdominis muscles, where thess thoracoabdominal nerves (T6-L1) contribute to the main sensory supply of the skin, muscles, and parietal peritoneum of the anterior abdominal wall. These nerves branch and communicate extensively with each other in the TAP .
Erector spinae plane (ESP) block is a recently described interfascial block in which the local anaesthectic is placed over or below the plane of the erector spinae muscle, near where the spinal nerves come out from the spine before they start to divide. Some publications have shown its effectiveness in treating thoracic and abdominal postoperative pain.
Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism, respiratory complications and prolongs the hospital stay. Parietal pain is the chief component of postoperative pain after abdominal surgeries. Large doses of opioids are required to mitigate this pain, but they are poorly tolerated. Multimodal analgesia is effective in handling postoperative pain and in attenuating the side effects of large doses of a single analgesic .
Group I (A group): Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side).
Group II (B group): Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side).
Group III (C group): anesthetized with the protocol followed by Minia University Hospital The medication will be prepared and supplied in similar syringes by an anesthetist not included in the management of the patint or data collection.
Methods:
Following placement of the standard monitors, intravenous access will secured and the patients will started on IV fluids. Anesthesia will be induced with 0.04 mg/kg midazolam, 2 μg/kg fentanyl, and titrated doses of propofol. Endotracheal intubation will facilitated with 0.5 mg/kg of atracurium. Isoflurane 1.2%, will be used for anesthetic maintenance After induction of anesthesia, stabilizing the patient's hemodynamics, and before surgical incision, ESB & TAP block will be performed. With the patient in the supine position, the site of the ultrasound and needle entry will be sterilized. The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected. Then the patient will turn in lateral position, the site of the ultrasound and needle entry will be sterilized. The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (A group) | Experimental | 31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). |
|
| Group II (B group) | Active Comparator | 31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). |
|
| Group III (C group) | Placebo Comparator | 31 patients anesthetized with the protocol followed by Minia University Hospital |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transversus abdominis plane block | Procedure | The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected |
| Measure | Description | Time Frame |
|---|---|---|
| Time of First Post Operative Analgesic Request | the pain will be assisted based on the time for the first dose of rescue analgesia | 24 hours |
| Postoperative Total Fentanyl Requirement | The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Any Adverse Events | adverse events related to technique or drugs | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nagy S. Ali, MD | Minia University Hospital | Study Chair |
| Abeer A Hassanien | Minia University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minia University Hospital | Minya | 61511 | Egypt |
7 patient refuse to participate
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I (A Group) | 31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes |
| FG001 | Group II (B Group) | 31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected |
| FG002 | Group III (C Group) | 31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I (A Group) | 31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time of First Post Operative Analgesic Request | the pain will be assisted based on the time for the first dose of rescue analgesia | Posted | Mean | Standard Deviation | Hour | 24 hours |
|
5 days
All patients were under control and receive the best care of management Our techniques don't make any side effects or affect patients outcome
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group I (A Group) | 31 patients Will undergo ESP block with 40 ml bupivacine 0.25% (20 ml on each side), and TAP block with 40 ml saline 0.9% (20 ml on each side). erector spinae plane block: The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hassan Elshorbagy | Minia university | 1204427271 | 0020 | Hassan.Hetta@mu.edu.eg |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2020 | Mar 8, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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|
| erector spinae plane block | Procedure | The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes |
|
| control group | Other | placebo |
|
| Group II (B Group) |
31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected |
| BG002 | Group III (C Group) | 31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | Group III (C Group) | 31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo |
|
|
| Primary | Postoperative Total Fentanyl Requirement | The total amount of postoperative fentanyl in milligram was given to the patient as rescue analgesia during 24 hours | Posted | Mean | Standard Deviation | Milligram | 24 hours |
|
|
|
| Secondary | Incidence of Any Adverse Events | adverse events related to technique or drugs | Posted | Number | participants | 5 days |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Group II (B Group) | 31patients Will undergo TAP block with 40 ml bupivacine 0.25% (20 ml on each side), and ESP block with 40 ml saline 0.9% (20 ml on each side). transversus abdominis plane block: The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected | 0 | 31 | 0 | 31 | 0 | 31 |
| EG002 | Group III (C Group) | 31 patients anesthetized with the protocol followed by Minia University Hospital control group: placebo | 0 | 31 | 0 | 31 | 0 | 31 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D008722 | Methods |