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

NCT05984160 | Unknown

• 1 other identifier: E-22686390-050.99-27043
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Post Operative Pain

Keywords

Obesity; Post operative pain; Pain block; Sleeve gastrectomy

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (16)

• First Rescue analgesia

  In first 24 hours

• Second Rescue analgesia

  In first 24 hours

• Rescue antiemetic

  In first 24 hours

• Time to rescue antiemetic

  In first 24 hours

• Time to first rescue analgesia

  In first 24 hours

Study Arms (2)

Paragastric neural block

ACTIVE COMPARATOR

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.

Other: Paragastric neural block

Control

NO INTERVENTION

Control grup

Interventions

Paragastric neural block OTHER

A block method used to control patients' symptoms of pain, nausea and vomiting after surgery.

Paragastric neural block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atlas University: lead

Study Sites (1)

Atlas university

Istanbul, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 12513041 BACKGROUND

• 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.

  PMID: 25562267 BACKGROUND

• 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.

  PMID: 35135657 BACKGROUND

• 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.

  PMID: 27771314 BACKGROUND

• 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.

  PMID: 34984504 BACKGROUND

• 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.

  PMID: 30706309 BACKGROUND

• 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.

  PMID: 34449029 BACKGROUND

• 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.

  PMID: 36050617 BACKGROUND

• 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.

  PMID: 21997984 BACKGROUND

• 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.

  PMID: 24414338 BACKGROUND

MeSH Terms

Conditions

Obesity; Pain, Postoperative

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations

Study Officials

• Mehmet K Katar, Assoc.Prof.

  Atlas University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization was performed by a general surgeon who would not be present during the block procedure. Patients were numbered sequentially according to the randomization scheme. Patient numbers were recorded in the follow-up files. Evaluation of the postoperative results was done by a general surgeon who was unaware of the group distributions. Since both the patients and the general surgeon who will make the evaluation did not know whether the block procedure was applied or not, the study was performed as double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients were divided into two groups as perigastric neural block and control group.

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 9, 2023
• Study Start: May 9, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 10, 2023
• Last Updated: August 9, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start after the publication.
• Access Criteria: All results of working can be shared with researchers after the study is published.

Locations

TU (1)