Paragastric Autonomic Blockade to Prevent Visceral Pain After Laparoscopic Sleeve Gastrectomy

NCT05353426 | Completed

• 1 other identifier: PRO-CEI-USB-CE-0394-00
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

Visceral pain (VP) following laparoscopic sleeve gastrectomy remains a substantial problem. VP is associated with autonomic symptoms, especially nausea and vomiting, and is unresponsive to traditional pain management algorithms aimed at alleviating somatic (incisional) pain. The present study was performed to evaluate the safety and effectiveness of laparoscopic paragastric autonomic neural blockade (PG-ANB) in managing the symptoms associated with VP following sleeve gastrectomy.

Conditions

Visceral Pain; Bariatric Surgery Candidate; Pain, Postoperative; Vomiting, Postoperative; Nausea, Postoperative

Keywords

Paragastric; Autonomic Block; Visceral pain; Opioids; Multimodal pain

Outcome Measures

Primary Outcomes (1)

• The patient-reported pain scores using an 11-point visual analog scale for pain( 11 being the worse pain).

  An analog pain scale survey was administered by an investigator blinded to the patients' groups at 1 hour postoperatively (in the recovery room), 8 hours postoperatively, and the following morning

  Outcomes were assessed up to 24 hours after surgery during the period of inpatient admission following LSG.

Secondary Outcomes (10)

• The secondary outcomes were analgesic requirements.

  The recorded administered doses of analgesics were assessed up 24 hours after surgery during the period of inpatient admission following LSG.

• The secondary outcome was present of nauseas

  Recorded up to 24 hours after surgery

• The secondary outcome was present of vomiting

  Recorded up to 24 hours after surgery

• The secondary outcome was present of retching

  Recorded up to 24 hours after surgery

• The secondary outcome was present of excessive salivation

  Recorded up to 24 hours after surgery

Study Arms (2)

PG-ANB Block

EXPERIMENTAL

The paragastric lesser omentum neural block is performed with a 25-gauge needle attached to a venous catheter extension introduced through the left 12-mm port. The needle is capped during its introduction, and the cap is removed inside the abdomen using a grasper and kept under direct vision. Infiltration of 20 mL of non-diluted 0.5% bupivacaine is performed at six levels with careful aspiration preceding fluid infiltration. Four of the areas are next to the vagus nerves and branches, and two are in the vicinity of the common hepatic and left gastric arteries

Procedure: Paragastric autonomic neural blockade

Control

NO INTERVENTION

No paragastric neural block is performed in the control group. The same standard analgesic protocol consisting of acetaminophen (1 g) and morphine (3-5 mg) is used in all patients before extubation and TAP block is performed in both groups (control and experimental)

Interventions

Paragastric autonomic neural blockade PROCEDURE

Paragastric autonomic neural blockade with Bupivacaine

Also known as: Laparoscopic transverses abdomens plane (TAP) block (To Both the control and experimental arms), Laparoscopic sleeve gastrectomy(LSG) to all patients

PG-ANB Block

Eligibility Criteria

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

You may qualify if:

• Adult patients who were scheduled for LSG at each participating institution from 25 August 2021 to 8 February 2022 and consented to study participation.

You may not qualify if:

• the performance of concomitant procedures in addition to LSG.
• allergies to medications included in the postoperative management protocol.
• anesthetic complications related to the LSG that would alter the postoperative management protocol.
• surgical complications related to the LSG that would alter the postoperative management protocol.

Sponsors & Collaborators

• Universidad Simón Bolívar: lead

Study Sites (1)

Clinica Portoazul

Barranquilla, Atlántico, 081007, Colombia

Location

Related Publications (9)

• Daes J, Jimenez ME, Said N, Daza JC, Dennis R. Laparoscopic sleeve gastrectomy: symptoms of gastroesophageal reflux can be reduced by changes in surgical technique. Obes Surg. 2012 Dec;22(12):1874-9. doi: 10.1007/s11695-012-0746-5.

  PMID: 22915063 BACKGROUND

• Browning KN, Travagli RA. Central nervous system control of gastrointestinal motility and secretion and modulation of gastrointestinal functions. Compr Physiol. 2014 Oct;4(4):1339-68. doi: 10.1002/cphy.c130055.

  PMID: 25428846 BACKGROUND

• Akinci D, Akhan O. Celiac ganglia block. Eur J Radiol. 2005 Sep;55(3):355-61. doi: 10.1016/j.ejrad.2005.03.008.

  PMID: 16129244 BACKGROUND

• Gress F, Schmitt C, Sherman S, Ikenberry S, Lehman G. A prospective randomized comparison of endoscopic ultrasound- and computed tomography-guided celiac plexus block for managing chronic pancreatitis pain. Am J Gastroenterol. 1999 Apr;94(4):900-5. doi: 10.1111/j.1572-0241.1999.01042.x.

  PMID: 10201454 BACKGROUND

• Ruiz-Tovar J, Munoz JL, Gonzalez J, Zubiaga L, Garcia A, Jimenez M, Ferrigni C, Duran M. Postoperative pain after laparoscopic sleeve gastrectomy: comparison of three analgesic schemes (isolated intravenous analgesia, epidural analgesia associated with intravenous analgesia and port-sites infiltration with bupivacaine associated with intravenous analgesia). Surg Endosc. 2017 Jan;31(1):231-236. doi: 10.1007/s00464-016-4961-3. Epub 2016 May 13.

  PMID: 27177956 BACKGROUND

• Iamaroon A, Tangwiwat S, Nivatpumin P, Lertwacha T, Rungmongkolsab P, Pangthipampai P. Risk Factors for Moderate to Severe Pain during the First 24 Hours after Laparoscopic Bariatric Surgery While Receiving Intravenous Patient-Controlled Analgesia. Anesthesiol Res Pract. 2019 Oct 3;2019:6593736. doi: 10.1155/2019/6593736. eCollection 2019.

  PMID: 31687018 BACKGROUND

• Tian C, Lee Y, Oparin Y, Hong D, Shanthanna H. Benefits of Transversus Abdominis Plane Block on Postoperative Analgesia after Bariatric Surgery: A Systematic Review and Meta-Analysis. Pain Physician. 2021 Aug;24(5):345-358.

  PMID: 34323436 BACKGROUND

• Joris J, Thiry E, Paris P, Weerts J, Lamy M. Pain after laparoscopic cholecystectomy: characteristics and effect of intraperitoneal bupivacaine. Anesth Analg. 1995 Aug;81(2):379-84. doi: 10.1097/00000539-199508000-00029.

  PMID: 7618731 BACKGROUND

• Daes J, Pantoja R, Hanssen A, et al.Paragastric, lesser omentum neural block to prevent early visceral pain after laparoscopic sleeve gastrectomy: A randomized clinical trial protocol. Revista Colombiana de Cirugia 2022;37:27-32. https://doi.org/10.30944/20117582.1017

  RESULT

MeSH Terms

Conditions

Visceral Pain; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Dental Occlusion

Condition Hierarchy (Ancestors)

Nociceptive Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Jorge Daes, MD FACS

  Academic Director Clinica portoazul, Barranquilla, Colombia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Designated Investigator

Model Details: A prospective, double-blinded, randomized clinical trial involving patients undergoing laparoscopic sleeve gastrectomy.

Study Record Dates

• First Submitted: April 16, 2022
• First Posted: April 29, 2022
• Study Start: August 13, 2021
• Primary Completion: February 3, 2022
• Study Completion: March 21, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)