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 .
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postoperative Pain Laparotomy | Procedure: transversus abdominis plane block Procedure: erector spinae plane block Other: control group | Not Applicable |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Prevention |
| Official Title: | Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies. |
| Actual Study Start Date : | May 15, 2019 |
| Actual Primary Completion Date : | February 1, 2020 |
| Actual Study Completion Date : | February 12, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 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).
|
Procedure: 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
|
|
Active Comparator: 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).
|
Procedure: 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
|
|
Placebo Comparator: Group III (C group)
31 patients anesthetized with the protocol followed by Minia University Hospital
|
Other: control group
placebo
|
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
| Egypt | |
| Minia University Hospital | |
| Minya, Egypt, 61511 | |
| Study Chair: | Nagy S. Ali, MD | Minia University Hospital | |
| Study Director: | Abeer A Hassanien | Minia University Hospital |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 4, 2019 | ||||||
| First Posted Date ICMJE | June 18, 2019 | ||||||
| Results First Submitted Date ICMJE | February 11, 2020 | ||||||
| Results First Posted Date ICMJE | March 25, 2020 | ||||||
| Last Update Posted Date | June 30, 2020 | ||||||
| Actual Study Start Date ICMJE | May 15, 2019 | ||||||
| Actual Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
Incidence of Any Adverse Events [ Time Frame: 5 days ] adverse events related to technique or drugs
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| Original Secondary Outcome Measures ICMJE |
Incidence of any side effect [ Time Frame: 24 hours ] complictions related to technique or drugs
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Transversus Abdominis Plane Block Versus Erector Spinae Plane Block | ||||||
| Official Title ICMJE | Ultrasound Guided Transversus Abdominis Plane Block Versus Erector Spinae Plane Block in Patients Undergoing Emergency Laparotomies. | ||||||
| Brief Summary |
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 . |
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| Detailed Description |
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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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Completed | ||||||
| Actual Enrollment ICMJE |
100 | ||||||
| Original Estimated Enrollment ICMJE |
90 | ||||||
| Actual Study Completion Date ICMJE | February 12, 2020 | ||||||
| Actual Primary Completion Date | February 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Egypt | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03989570 | ||||||
| Other Study ID Numbers ICMJE | 73-7/2018 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Hassan Mokhtar Elshorbagy Hetta, Minia University | ||||||
| Study Sponsor ICMJE | Hassan Mokhtar Elshorbagy Hetta | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Minia University | ||||||
| Verification Date | June 2020 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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