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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NOT_YET_RECRUITING
PHASE2/PHASE3
72 participants
INTERVENTIONAL
2024-01-01
2025-02-20
Brief Summary
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Detailed Description
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Postoperative pain is the major obstacle for early postoperative ambulation and prolongs the hospital stay. Moreover, it has been hypothesized that intense acute pain after LC may predict development of chronic pain (e.g., post laparoscopic cholecystectomy syndrome). So, aggressive perioperative pain prevention is mandatory.
This pain is routinely managed using opiates, which has several side effects. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall. Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall, specifically from T6 to L1.
Rafi et al and McDonnell et al were the first to describe (OSCTAP) block. They described an anatomical landmark technique and provided evidence of blockade to the mid/lower thoracic and upper lumbar spinal nerves as they travelled in the fascial plane between the transversus abdominis (TA) and internal oblique (IO) muscles.
Evidence supporting the presence of (NMDA) receptors in skin and muscles have led to the use of (MgSO4) which is NMDA antagonist via different routes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline plus 20 ml of 0.25 % bupivacaine)
Bupivacaine plus normal saline
Unlike specific peripheral nerve blocks, TAP block is a non-dermatomal "field block". Even with the same US-guided technique, the extent of spread of local anesthetics can be variable due to individual anatomical variations (18). In order to perform the blocks, abdominal skin will be prepared and covered with sterile drapes. The needle can be introduced by multiple punctures along the oblique subcostal line from the xiphoid process towards the anterior part of the iliac crest .Thus, LA will be injected in the TAP along this line provides both upper and lower abdominal wall analgesia. The OSCTAP block more consistently covers L1 dermatome. After negative aspiration, a test injection with 1 ml of 0.9% normal saline will be performed to confirm the needle location. If the intended sensation will not decreased in surgical dermatomes after 30 min, the patient will be regarded to have a failed block and will be excluded from the study.
Group B
24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline containing 500 mg MgSO4 plus 20 ml of 0.25% bupivacaine)
Bupivacaine plus normal saline containing MgSO4
Bupivacaine plus normal saline containing MgSO4
Group C
24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline containing 250 mg MgSO4 plus 20 ml of 0.25% bupivacain)
Bupivacaine plus normal saline containing MgSO4
Bupivacaine plus normal saline containing MgSO4
Interventions
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Bupivacaine plus normal saline
Unlike specific peripheral nerve blocks, TAP block is a non-dermatomal "field block". Even with the same US-guided technique, the extent of spread of local anesthetics can be variable due to individual anatomical variations (18). In order to perform the blocks, abdominal skin will be prepared and covered with sterile drapes. The needle can be introduced by multiple punctures along the oblique subcostal line from the xiphoid process towards the anterior part of the iliac crest .Thus, LA will be injected in the TAP along this line provides both upper and lower abdominal wall analgesia. The OSCTAP block more consistently covers L1 dermatome. After negative aspiration, a test injection with 1 ml of 0.9% normal saline will be performed to confirm the needle location. If the intended sensation will not decreased in surgical dermatomes after 30 min, the patient will be regarded to have a failed block and will be excluded from the study.
Bupivacaine plus normal saline containing MgSO4
Bupivacaine plus normal saline containing MgSO4
Eligibility Criteria
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Inclusion Criteria
* American society of anesthesiologists (ASA) physical state I or II.
* Age over 18 years and less than 60 years old.
* Patients of both sex are included in the study.
Exclusion Criteria
* Known hypersensitivity to the study drugs.
* Body Mass Index \> 40 kg/m2.
* Inability to accurately describe postoperative pain to investigators.
* Opioid tolerance or dependence.
* Preexisting history of chronic pain.
* History of renal, liver, cardiac, neuropsychiatric disorder problems.
* Bleeding or coagulation abnormality.
18 Years
60 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Mahmoud Yamany Mohamed Kamel
Principle Investigator
Principal Investigators
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Fatma Askar
Role: STUDY_CHAIR
Professor of Anesthesia and Intensive Care
Central Contacts
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References
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Grape S, Kirkham KR, Akiki L, Albrecht E. Transversus abdominis plane block versus local anesthetic wound infiltration for optimal analgesia after laparoscopic cholecystectomy: A systematic review and meta-analysis with trial sequential analysis. J Clin Anesth. 2021 Dec;75:110450. doi: 10.1016/j.jclinane.2021.110450. Epub 2021 Jul 6.
Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6.
Other Identifiers
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Post operative pain
Identifier Type: -
Identifier Source: org_study_id