Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy
NCT ID: NCT05984160
Last Updated: 2023-08-09
Study Results
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Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2023-05-09
2023-08-10
Brief Summary
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Although minimally invasive bariatric surgical procedures are applied today, postoperative pain is one of the most basic problems. Opioid-derived drugs used for pain control cause respiratory depression and constipation. Enhanced Recovery After Surgery (ERAS) protocols recommend reducing opioid use after bariatric surgery to help patients have a healthier postoperative period.
Different methods such as transversus abdominis plane (TAP) block and erector spinae plane (ESP) block are used to reduce the postoperative opioid dose and for effective pain control. While these methods are effective in controlling somatic pain, they have no effect on visceral pain.
It has been shown that patients' pain and opioid consumption decrease especially after celiac plexus block. Vagal and sympathetic afferent stimuli from the gastrointestinal tract, on the other hand, stimulate the vomiting center and cause nausea and vomiting. Paragastric neural block is a new method performed by injecting local anesthetic into the posterosuperior paragastric area in the area covering the left gastric artery by revealing the esophagogastric junction, proximal stomach, middle of the stomach, distal antrum, hepatoduodenal ligament and stomach posterior along the border of the lesser omentum. In this way, it is aimed to prevent both visceral pain and the symptoms of nausea and vomiting.
In our study, the investigators aimed to evaluate the efficacy and safety of paragastric nerve block applied during laparoscopic sleeve gastrectomy by comparing it with the control group.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Paragastric neural block
Patients who were operated for sleeve gastrectomy were included in the study. Afterwards, they were divided into two groups. While pragastric neural block was applied to one group, no intervention was made to the other group.
Paragastric neural block
A block method used to control patients' symptoms of pain, nausea and vomiting after surgery.
Control
Control grup
No interventions assigned to this group
Interventions
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Paragastric neural block
A block method used to control patients' symptoms of pain, nausea and vomiting after surgery.
Eligibility Criteria
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Inclusion Criteria
* Body mass index of over 40,
* Patients who underwent laparoscopic sleeve gastrectomy,
* ASA risk score of 2-3,
* Agreed to be included in the study.
Exclusion Criteria
* Opioid addicts,
* Using anticoagulant drugs,
* History of previous upper gastrointestinal system surgery,
* Surgical complications during or after surgery,
* Hepatic or renal failure,
* Moderate or severe cardiovascular or respiratory disease,
* Allergy to the local anesthetic agent to be applied for the block,
* Limited cooperation,
* More than one surgical intervention in the same session,
* Allergy to the drugs to be used in the postoperative treatment protocol.
18 Years
65 Years
ALL
No
Sponsors
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Atlas University
OTHER
Responsible Party
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Principal Investigators
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Mehmet K Katar, Assoc.Prof.
Role: PRINCIPAL_INVESTIGATOR
Atlas University
Locations
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Atlas university
Istanbul, , Turkey (Türkiye)
Countries
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References
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Peeters A, Barendregt JJ, Willekens F, Mackenbach JP, Al Mamun A, Bonneux L; NEDCOM, the Netherlands Epidemiology and Demography Compression of Morbidity Research Group. Obesity in adulthood and its consequences for life expectancy: a life-table analysis. Ann Intern Med. 2003 Jan 7;138(1):24-32. doi: 10.7326/0003-4819-138-1-200301070-00008.
Arterburn DE, Olsen MK, Smith VA, Livingston EH, Van Scoyoc L, Yancy WS Jr, Eid G, Weidenbacher H, Maciejewski ML. Association between bariatric surgery and long-term survival. JAMA. 2015 Jan 6;313(1):62-70. doi: 10.1001/jama.2014.16968.
Liu JJ, Brenner DM. Opioid-Related Constipation. Gastroenterol Clin North Am. 2022 Mar;51(1):107-121. doi: 10.1016/j.gtc.2021.10.007. Epub 2022 Jan 8.
Budiansky AS, Margarson MP, Eipe N. Acute pain management in morbid obesity - an evidence based clinical update. Surg Obes Relat Dis. 2017 Mar;13(3):523-532. doi: 10.1016/j.soard.2016.09.013. Epub 2016 Sep 19.
Stenberg E, Dos Reis Falcao LF, O'Kane M, Liem R, Pournaras DJ, Salminen P, Urman RD, Wadhwa A, Gustafsson UO, Thorell A. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations: A 2021 Update. World J Surg. 2022 Apr;46(4):729-751. doi: 10.1007/s00268-021-06394-9. Epub 2022 Jan 4.
Emile SH, Abdel-Razik MA, Elbahrawy K, Elshobaky A, Shalaby M, Elbaz SA, Gado WA, Elbanna HG. Impact of Ultrasound-Guided Transversus Abdominis Plane Block on Postoperative Pain and Early Outcome After Laparoscopic Bariatric Surgery: a Randomized Double-Blinded Controlled Trial. Obes Surg. 2019 May;29(5):1534-1541. doi: 10.1007/s11695-019-03720-y.
Zengin SU, Ergun MO, Gunal O. Effect of Ultrasound-Guided Erector Spinae Plane Block on Postoperative Pain and Intraoperative Opioid Consumption in Bariatric Surgery. Obes Surg. 2021 Dec;31(12):5176-5182. doi: 10.1007/s11695-021-05681-7. Epub 2021 Aug 27.
Daes J, Morrell DJ, Hanssen A, Caballero M, Luque E, Pantoja R, Luquetta J, Pauli EM. Paragastric Autonomic Neural Blockade to Prevent Early Visceral Pain and Associated Symptoms After Laparoscopic Sleeve Gastrectomy: a Randomized Clinical Trial. Obes Surg. 2022 Nov;32(11):3551-3560. doi: 10.1007/s11695-022-06257-9. Epub 2022 Sep 2.
Kambadakone A, Thabet A, Gervais DA, Mueller PR, Arellano RS. CT-guided celiac plexus neurolysis: a review of anatomy, indications, technique, and tips for successful treatment. Radiographics. 2011 Oct;31(6):1599-621. doi: 10.1148/rg.316115526.
Rana MV, Candido KD, Raja O, Knezevic NN. Celiac plexus block in the management of chronic abdominal pain. Curr Pain Headache Rep. 2014 Feb;18(2):394. doi: 10.1007/s11916-013-0394-z.
Other Identifiers
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E-22686390-050.99-27043
Identifier Type: -
Identifier Source: org_study_id
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