Efficacy of Paragastric Neural Block Procedure on Postoperative Pain in Patients Who Underwent Sleeve Gastrectomy

Obesity Clinical Trial

Official title:

Efficacy and Safety of Paragastric Neural Block in Controlling Pain, Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy; Prospective Randomized Controlled Double-blind Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05984160
• Other study ID #: E-22686390-050.99-27043
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 9, 2023
• Est. completion date: August 10, 2023

Study information

• Verified date: July 2023
• Source: Atlas University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Surgical treatment is the most effective way to achieve effective and sustainable weight loss in patients with obesity and to improve the comorbidities caused by it. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: August 10, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index of over 35 and an obesity-related comorbidity,
• 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:

• Chronic pain disorder or using gabapentin,
• 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.

Related Conditions & MeSH terms

• Obesity
• Pain, Postoperative
• Post Operative Pain

Intervention

Other:
• Paragastric neural block
A block method used to control patients' symptoms of pain, nausea and vomiting after surgery.

Locations

Country	Name	City	State
Turkey	Atlas university	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Atlas University

Country where clinical trial is conducted

Turkey, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: World J Surg. 2022 Jan 29;: — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	The investigators used visual analog scale. Minimum value 0 (means no pain), maximum values 10 (means worst pain ever).	In first 24 hours
Primary	Postoperative nause and vomiting	The investigators used Post operative nause and vomiting impact scale. Minimum value 0, maximum values 6. Total score >4 defines clinically important postoperative nause and vomiting.	In first 24 hours
Secondary	First Rescue analgesia	Did patients need first rescue analgesia?	In first 24 hours
Secondary	Second Rescue analgesia	Did patients need second rescue analgesia?	In first 24 hours
Secondary	Rescue antiemetic	Did patients need rescue antiemetic drug?	In first 24 hours
Secondary	Time to rescue antiemetic	When patients need rescue antiemetic drug?	In first 24 hours
Secondary	Time to first rescue analgesia	When patients need first rescue analgesia?	In first 24 hours
Secondary	Time to second rescue analgesia	when patients need second rescue analgesia?	In first 24 hours
Secondary	First mobilization time	When patients start to walk?	In first 24 hours
Secondary	Operation time	How long did the surgery take?	Through operation completion, an avarage of 1 hour
Secondary	Patient satisfaction	The investigators used likert scale. Minimum value 1 (very unsatisfied), maximum values 5 (very satisfied).	In first 72 hours
Secondary	Pulse before block	Pulse before block	at block moment
Secondary	Pulse 10 minutes after the block	Pulse 10 minutes after the block	10 minutes after the block
Secondary	Sistolic blood pressure before the block	Sistolic blood pressure before the block	at block moment
Secondary	Sistolic blood pressure 10 minutes after the block	Sistolic blood pressure 10 minutes after the block	10 minutes after the block
Secondary	Diastolic blood pressure before the block	Diastolic blood pressure before the block	at block moment
Secondary	Diastolic blood pressure 10 minutes after the block	Diastolic blood pressure 10 minutes after the block	10 minutes after the block
Secondary	Complication at the block site	Were there any complications during the block?	Through operation, an avarage of 1 hour