Comparison of Abdominal Plane Blocks in Postoperative Pain Control in Patients Undergoing LSG

Comparison of Abdominal Plane Blocks in Terms of Efficiency and Complications in Postoperative Pain Control in Patients Undergoing Laparoscopic Sleeve Gastrectomy

The goal of this prospective observational study is compare in terms of efficiency and complications transversus abdominis plane (TAP) and Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) blocks in patients undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analgesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.

Study Overview

• Status: Completed
• Conditions: Anesthesia and Analgesia; Anesthesia, Regional; Bariatric Surgical Procedures
• Intervention / Treatment: Procedure: TAP block group; Procedure: m-TAPA block group

Detailed Description

After laparoscopic sleeve gastrectomy, patients have pain due to surgery. Different analgesic methods are preferred for pain relief. One of the methods used for this purpose is regional anesthesia. Modified thoracoabdominal plane block-perichondrial approach (M-TAPA) and transversus abdominis plane (TAP) block are also plan blocks used for this purpose. TAP block is formed by injecting local anesthetic into the neurofacial space between the transversus abdominis muscle and the internal oblique muscle through the Petit triangle in the lumbar region. TAP block creates dermatomal sensory block in the lower, lower thoracic and upper lumbar abdominal afferents. It is thought that the modified thoracoabdominal plane block-perichondrial approach (M-TAPA), which is a block frequently used in upper abdomen surgeries in recent years, can provide effective analgesia in LSG surgeries. M-TAPA block is created by administering local anesthetic between the transverse abdominis muscle and the internal oblique muscle with a single injection under the costal cartilage under ultrasound guidance. With M-TAPA, analgesia can be provided in thoracic 4 and thoracic 11-12 dermatomes.

Blocking of T4-12 nerve endings may be required in LSG surgeries, since gastric innervation and thoracic inlets are located in the upper abdomen dermatomes. In studies, the use of M-TAPA block in upper abdominal surgeries may be effective in the management of analgesia in participants. In this study the investigators aimed that, compression in terms of efficiency and complications TAP and M-TAPA blocks, who is undergoing laparoscopic sleeve gastrectomy. The investigators aims to examine whether M-TAPA block provides more effective analjesia than TAP block in upper abdomen surgeries, and whether there is any difference in terms of nausea- vomiting and need for additional analgesics. After obtaining ethical committee approval (12.01.2023/1), between January 26, 2023, and May 15, 2024, 60 patients undergoing laparoscopic sleeve gastrectomy with American Society of Anesthesiologists (ASA) II-III status provide informed consent. Participants who are planing to receive M-TAPA block defines as Group M-TAPA, and those who receive TAP block defines as Group TAP, with 30 patients in each group.The participitans will be observed for postoperative 24 hours with numeric rating score (NRS), postoperative nausea-vomiting score (PNVS) and in terms of need for additional analgesic dose.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Gamze Nur Teke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients between the ages of 18-65, including the ASA I-III group, who underwent laparoscopic sleeve gastrectomy by the General Surgery clinic between January 26, 2023 and May 15, 2023

Exclusion Criteria:

• Patients with coronary artery disease
• Patients with cerebrovascular disease
• Patients with peripheral artery disease
• History of chronic analgesic use
• Patients with coagulopathy
• Patients not between the ages of 18-65
• Patients with hepatic and/or renal insufficiency
• Patients with missing information in the information form

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TAP block; Transversus Abdominal Plane Block aplied after LSG. In TAP block local anesthetic(%0,25 bupivacaine-20ml)will be administrated the between the transversus abdominis muscle and the internal abdominal muscle fascia.	Procedure: TAP block group; TAP block will be administrated after LSG. In TAP block local anesthetic(%0,25 bupivacaine-20ml)will be administrated the between the transversus abdominis muscle and the internal abdominal muscle fascia.
Active Comparator: m-TAPA block; Modified-Thoracoabdominal Plane Block-pericondrial approach aplied after LSG. In m-TAPA block local anesthetic (0.25% bupivacaine-20ml) will be administrated between the transversus abdominis muscle and the internal abdominal muscle fascia under the costochondrial region.	Procedure: m-TAPA block group; m-TAPA block will be administrated after LSG. In m-TAPA block local anesthetic (0.25% bupivacaine-20ml) will be administrated between the transversus abdominis muscle and the internal abdominal muscle fascia under the costochondrial region

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numeric Rate Score (NRS)	NRS is a 0 to 10 scale that describes pain from good to worst.	It will be evaluated with (which ), at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
Visual Analog Scale (VAS)	VAS is a 10-centimeter scale and is used to evaluate pain.	PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours
Pain Controlled Analgesia (PCA)	PCA is includes 300mg Tramadol/100 ml SF- no infusion, 5cc bolus, 15 minutes lock	PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nausea and vomiting scale (PNV)	PNV is a 0 to 4 scale that describes nausea and vomiting from good to worst.	It will be evaluated with nause and vomiting score at PACU 5,15, 30th minutes and postoperative 1, 3, 6, 12, 24th hours

Collaborators and Investigators

• Sponsor: Fatih Sultan Mehmet Training and Research Hospital
• Investigators: Study Director: arzu yıldırım ar, Fatih Sultan Mehmet Training and Research Hospital

Publications and helpful links

General Publications

• McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
• 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. Erratum In: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added].
• McDonnell JG, O'Donnell BD, Farrell T, Gough N, Tuite D, Power C, Laffey JG. Transversus abdominis plane block: a cadaveric and radiological evaluation. Reg Anesth Pain Med. 2007 Sep-Oct;32(5):399-404. doi: 10.1016/j.rapm.2007.03.011.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2023
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: February 25, 2023
• First Submitted That Met QC Criteria: December 30, 2023
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: LSG; TAP; plane block; m-TAPA; pain manangement
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: gamzenurteke-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No