Adding Magnesium Sulfate or Dexmedetomidine to Bupivacaine in Oblique Subcostal Tap Block for Laparoscopic Cholecystectomy: a Randomized Double -Blind Controlled Study
NCT ID: NCT06743919
Last Updated: 2024-12-20
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
PHASE4
63 participants
INTERVENTIONAL
2025-01-01
2026-03-01
Brief Summary
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the aim of the study is To compare the analgesic effect of magnesium sulfate combined with bupivacaine versus bupivacaine combined dexmedetomidine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.
Detailed Description
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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. There weren't enough studies in the literature evaluating the OSCTAP block for pain management after LC.
Rafi et al and McDonnell et al were first to describe this novel abdominal field 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.
The OSCTAB block provides more effective analgesia than other TAP blocks. Numerous regional anesthetic adjuvants.
such as dexmedetomidine, clonidine, epinephrine, dexamethasone, and magnesium sulphate (MgSO4) are usually combined with enhancement of analgesic efficacy.
Recently, these adjuvants added to LA solution for prolonging the effect of TAP block with promising results.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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group 1
patient will receive 20 ml bupivacaine 0.25% plus 500 mg magnesium sulfate in 5ml normal saline on both sides.
Magnesium sulfate 50% - 1g/h
magnesium sulfate group 20 ml bupivacaine 0.25% plus 500 mg magnesium sulfate in 5ml normal saline on both sides.
Bupivacaine
20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
group 2
patients will receive 20 ml bupivacaine 0.25% plus o .5 microg per kg dexmedetomidine in 5 ml normal saline on both sides.
dexmedetomidine 0.5 µg/kg IV
dexmedetomidine group 20 ml bupivacaine 0.25% plus o .5 microg per kg dexmedetomidine in 5 ml normal saline on both sides.
Bupivacaine
20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
group 3
patients will receive 20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
Bupivacaine
20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
Interventions
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Magnesium sulfate 50% - 1g/h
magnesium sulfate group 20 ml bupivacaine 0.25% plus 500 mg magnesium sulfate in 5ml normal saline on both sides.
dexmedetomidine 0.5 µg/kg IV
dexmedetomidine group 20 ml bupivacaine 0.25% plus o .5 microg per kg dexmedetomidine in 5 ml normal saline on both sides.
Bupivacaine
20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
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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Khaled Zaki Mousa Sayed Mansour
resident doctor at Assiut University hospital
Central Contacts
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Khaled Zaki Mousa Sayed Mansour, resident doctor
Role: CONTACT
Phone: +2 01032468020
Email: [email protected]
References
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Sun C, He Z, Feng B, Huang Y, Liu D, Sun Z. Effect of Intraperitoneal Instillation of Dexmedetomidine With Local Anesthetics in Laparoscopic Cholecystectomy: A Systematic Review and Meta-analysis of Randomized Trials. Surg Laparosc Endosc Percutan Tech. 2024 Apr 1;34(2):222-232. doi: 10.1097/SLE.0000000000001262.
Lee TH, Barrington MJ, Tran TM, Wong D, Hebbard PD. Comparison of extent of sensory block following posterior and subcostal approaches to ultrasound-guided transversus abdominis plane block. Anaesth Intensive Care. 2010 May;38(3):452-60. doi: 10.1177/0310057X1003800307.
O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.
Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.
Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.
Bisgaard T, Rosenberg J, Kehlet H. From acute to chronic pain after laparoscopic cholecystectomy: a prospective follow-up analysis. Scand J Gastroenterol. 2005 Nov;40(11):1358-64. doi: 10.1080/00365520510023675.
Petersen PL, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB, Mathiesen O. The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial. Anesth Analg. 2012 Sep;115(3):527-33. doi: 10.1213/ANE.0b013e318261f16e. Epub 2012 Jul 4.
Other Identifiers
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OSCTAP Cholecystectomy
Identifier Type: -
Identifier Source: org_study_id