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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06201546
Enrollment
30
Registered
2024-01-11
Start date
2023-02-25
Completion date
2023-05-30
Last updated
2024-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgical Procedures, Anesthesia and Analgesia, Anesthesia, Regional

Keywords

LSG, TAP, m-TAPA, pain manangement, plane block

Brief summary

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.

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.

Interventions

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.

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

Sponsors

Fatih Sultan Mehmet Training and Research Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Masking description

Due to the double-blind nature of the study, the outcome of the effectiveness of plane blocks will not be known by the anesthesiologist and the patient until the end of the study. Only the effectiveness of blocks will be followed by an another researcher

Intervention model description

Clinical trial in which two groups of participants who are applied two type plane blocks. Group A; TAP block and group B; m-TAPA block. Effectiveness of blocks will be followed by appliying Pain Controlled Analgesia(PCA) and with pain scales as Visual Analog Scale(VAS) and Numerating Rate Scale.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026