Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
62 participants
INTERVENTIONAL
2020-02-28
2020-10-15
Brief Summary
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Detailed Description
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The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used effectively in laparotomies. Unilateral analgesia to the skin, muscles, and parietal peritoneum of the anterior abdominal wall will be achieved without affecting visceral pain, when the anterior rami of the lower six thoracic nerves (T7-T12) and the first lumbar nerve (L1) are blocked.
Erector spinae plane block (ESPB) was shown to be an effective analgesic option for different types of surgeries. It's relatively a simple block, drug is injected in the plane between the erector spinae muscle and the vertebral transverse process. Blocking the ventral and dorsal rami of spinal nerves on the paravertebral area distributed from T2-T4 to L1-L2 and gives good coverage to visceral pain. Owing to the lower risk of blood vessel damage and neural damage compared to the epidural or the paravertebral block.
Both blocks haven't been compared to each other in this type of surgery before.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Transversus abdomis plane block
Patients will receive Transversus abdomis plane block
lower abdominal surgery
Patients will undergo lower abdominal surgery under general anesthesia.
Transversus abdominis plane block
patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).
Erector spinae plane block
Patients will receive Erector spinae plane block.
lower abdominal surgery
Patients will undergo lower abdominal surgery under general anesthesia.
Erector spinae plane block
patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).
Interventions
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lower abdominal surgery
Patients will undergo lower abdominal surgery under general anesthesia.
Erector spinae plane block
patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).
Transversus abdominis plane block
patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 and ≤ 65 Years.
* Cancer patients undergoing laparotomies for radical cystectomy or radical hysterectomy or low anterior resection (lower abdominal procedures).
* Patient is able to provide a written informed consent.
* Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.
Exclusion Criteria
* BMI \<20 kg/m2 and \>40 kg/m2.
* Known sensitivity to local anaesthetics and morphine.
* History of psychological disorders and/or chronic pain.
* Significant liver or renal insufficiency.
* Contraindication to regional anaesthesia e.g. local sepsis, preexisting peripheral neuropathies and coagulopathy.
* Patient refusal.
* Severe respiratory or cardiac disorders.
* Pregnancy.
* ASA III-IV.
18 Years
65 Years
ALL
No
Sponsors
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National Cancer Institute, Egypt
OTHER
Responsible Party
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Ahmed Shaban Mohammed
Assistant lecturer of anesthesia and critical care medicine
Principal Investigators
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waleed hamimy, Professor
Role: STUDY_CHAIR
Cairo University
Locations
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National Cancer Institute
Cairo, , Egypt
Countries
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Central Contacts
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References
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Randerath WJ, George S. Opioid-induced sleep apnea: is it a real problem? J Clin Sleep Med. 2012 Oct 15;8(5):577-8. doi: 10.5664/jcsm.2162. No abstract available.
Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x.
Hebbard P. Subcostal transversus abdominis plane block under ultrasound guidance. Anesth Analg. 2008 Feb;106(2):674-5; author reply 675. doi: 10.1213/ane.0b013e318161a88f. No abstract available.
Yarwood J, Berrill A (2010). Nerve blocks of the anterior abdominal wall, Continuing Education in Anaesthesia Critical Care & Pain, Vol10, Issue 6, pp 182-186.
Abrahams MS, Horn JL, Noles LM, Aziz MF. Evidence-based medicine: ultrasound guidance for truncal blocks. Reg Anesth Pain Med. 2010 Mar-Apr;35(2 Suppl):S36-42. doi: 10.1097/AAP.0b013e3181d32841.
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.
De Cassai A, Marchet A, Ori C. The combination of erector spinae plane block and pectoralis blocks could avoid general anesthesia for radical mastectomy in high risk patients. Minerva Anestesiol. 2018 Dec;84(12):1420-1421. doi: 10.23736/S0375-9393.18.13031-8. Epub 2018 Jul 9. No abstract available.
Other Identifiers
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MS-39-2019
Identifier Type: -
Identifier Source: org_study_id
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