Comparison of M-TAPA and ESPB for Postoperative Pulmonary Function After Laparoscopic Cholecystectomy
Comparison of the Effects of Erector Spinae Plane Block and Modified Thoracoabdominal Nerve Block Through Perichondrial Approach on Postoperative Pulmonary Function and Analgesic Consumption in Patients Undergoing Laparoscopic Cholecystectomy
This prospective, randomized, controlled clinical trial aims to compare the effects of two ultrasound-guided fascial plane blocks, the Erector Spinae Plane Block (ESPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), on postoperative pulmonary function and analgesic consumption in patients undergoing laparoscopic cholecystectomy. Laparoscopic cholecystectomy is one of the most frequently performed abdominal surgical procedures worldwide. Despite minimally invasive techniques, postoperative pain remains a significant clinical problem due to port-site trauma, pneumoperitoneum, diaphragmatic irritation, and visceral manipulation.
Inadequate pain control may lead to impaired respiratory mechanics, reduced mobilization, delayed recovery, and an increased risk of postoperative pulmonary complications. Postoperative pulmonary dysfunction is a common consequence of upper abdominal surgery and may persist for several days, contributing to reductions in forced vital capacity (FVC) and forced expiratory volume in one second (FEV1), which are associated with increased postoperative morbidity.
Although opioid-based analgesia is widely used, it is associated with adverse effects such as respiratory depression, nausea, vomiting, ileus, and delayed recovery. Therefore, regional anesthesia techniques and multimodal analgesia strategies are increasingly recommended to reduce opioid consumption while improving pain control.
ESPB and M-TAPA are ultrasound-guided fascial plane blocks used for postoperative analgesia in abdominal surgery. ESPB provides somatic and visceral analgesia through the spread of local anesthetic affecting the spinal nerve rami, while M-TAPA targets the anterior branches of the thoracoabdominal nerves to provide extensive anterior and lateral abdominal wall analgesia.
Despite their increasing use, there is limited high-quality comparative evidence evaluating the effects of ESPB and M-TAPA on postoperative pulmonary function and opioid consumption in laparoscopic cholecystectomy. This study compares these two regional anesthesia techniques in a randomized controlled design to evaluate their impact on postoperative respiratory function and analgesic requirements.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
This study is a prospective, randomized, controlled clinical trial designed to compare the effects of two ultrasound-guided fascial plane blocks, the Erector Spinae Plane Block (ESPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA), on postoperative pulmonary function and analgesic consumption in patients undergoing laparoscopic cholecystectomy.
A total of 60 patients will be randomly allocated into two groups: ESPB group (n=30) and M-TAPA group (n=30). All patients will undergo standard general anesthesia. After induction of general anesthesia and before surgical incision, regional blocks will be performed.
Patients in the ESPB group will receive bilateral ultrasound-guided erector spinae plane block at the T9 vertebral level using 0.25% bupivacaine, 20 mL per side (total 40 mL). Patients in the M-TAPA group will receive bilateral ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach using the same concentration and volume of local anesthetic (0.25% bupivacaine, total 40 mL).
All blocks will be performed under sterile conditions using a high-frequency linear ultrasound probe and an 80 mm echogenic needle.
All patients will receive standardized multimodal analgesia, including intravenous paracetamol (1 g every 8 hours) and intravenous ibuprofen (400 mg every 12 hours) for 24 hours postoperatively. The first doses of paracetamol and ibuprofen will be administered 10 minutes before the end of surgery.
Postoperative pain will be assessed using the Numeric Rating Scale (NRS) at rest and during movement at 1, 6, 12, 18, and 24 hours after surgery. Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia. The PCA device will be set to deliver 1 mg morphine boluses with a lockout interval of 15 minutes and a maximum dose of 96 mg within 24 hours. Rescue analgesia with intravenous fentanyl (25 mcg) will be administered in patients with persistent pain (NRS ≥4 despite PCA bolus).
Total opioid consumption will be calculated as cumulative morphine consumption within the first 24 postoperative hours.
Pulmonary function tests will be performed preoperatively and at 1, 6, and 24 hours postoperatively, including forced vital capacity (FVC), forced expiratory volume in one second (FEV1), FEV1/FVC ratio, and peak expiratory flow (PEF).
Postoperative recovery quality will be evaluated using the Quality of Recovery-15 (QoR-15) questionnaire at 24 hours after surgery.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Muhammed N Tekcan, Anesthesiology and Reanimation
- Puhelinnumero: +905387931833
- Sähköposti: mntekcan@gmail.com
Opiskelupaikat
-
-
Kocasinan
-
Kayseri, Kocasinan, Turkki (Türkiye), 38080
- Rekrytointi
- Kayseri City Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Patients aged 18-70 years
- American Society of Anesthesiologists (ASA) physical status I-III
- Patients scheduled for elective laparoscopic cholecystectomy
- Patients who provide written informed consent
- Patients who are able to cooperate and perform pulmonary function tests (PFTs)
Exclusion Criteria:
- Coagulation disorders or anticoagulant therapy contraindicating regional anesthesia
- Infection at the planned block site
- Known allergy to local anesthetic agents
- Conversion to open surgery
- Hemodynamic instability
- Inability to cooperate with pulmonary function tests (PFTs)
- Pre-existing severe pulmonary disease (e.g., severe chronic obstructive pulmonary disease or restrictive lung disease)
- Chronic opioid use or opioid dependence
- Pregnancy or breastfeeding
- Active smokers
- Body mass index (BMI) > 35 kg/m²
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: M-TAPA Block
An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) performed bilaterally with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
|
An ultrasound-guided modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA) was performed bilaterally under sterile conditions.
The ultrasound transducer was placed in the sagittal plane at the 9th-10th rib level.
The probe was angled to visualize the underside of the costal margin.
After identification of the target fascial plane, an echogenic needle was advanced in-plane until the tip was positioned beneath the costal cartilage.
Hydrodissection with 5 mL of saline was used to confirm correct needle placement.
Following confirmation, 20 mL of 0.25% bupivacaine was administered on each side, for a total volume of 40 mL.
Blocks were performed under ultrasound guidance using an 80 mm echogenic needle and a 6-10 MHz linear transducer.
|
|
Kokeellinen: Erector spinae plane block (ESPB)
An ultrasound-guided erector spinae plane block (ESPB) performed with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
|
An ultrasound-guided erector spinae plane block (ESPB) was performed bilaterally at the T9 vertebral level under sterile conditions.
A high-frequency linear ultrasound probe (6-10 MHz) was used to identify the erector spinae muscle and transverse process.
An 80 mm echogenic needle was advanced in-plane in a cranio-caudal direction until the tip was positioned in the fascial plane deep to the erector spinae muscle.
Hydrodissection with saline was used to confirm correct needle placement, followed by administration of 20 mL of 0.25% bupivacaine on each side, for a total volume of 40 mL.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1)
Aikaikkuna: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
|
Forced expiratory volume in one second (FEV1, liters) will be measured to assess postoperative pulmonary function.
|
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
|
|
Forced Vital Capacity (FVC)
Aikaikkuna: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
|
Forced vital capacity (FVC, liters) will be measured to assess postoperative pulmonary function.
|
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
|
|
FEV1/FVC Ratio
Aikaikkuna: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
|
The FEV1/FVC ratio (percentage, %) will be measured to assess postoperative pulmonary function.
|
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
|
|
Peak Expiratory Flow (PEF)
Aikaikkuna: Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
|
Peak expiratory flow (PEF, liters/minute) will be measured to assess postoperative pulmonary function.
|
Preoperatively (baseline), and at 1, 6, and 24 hours postoperatively.
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Total Opioid Consumption
Aikaikkuna: First 24 postoperative hours
|
Total opioid consumption will be calculated as cumulative morphine dose delivered via patient-controlled analgesia (PCA) and rescue analgesic requirements during the first 24 postoperative hours.
|
First 24 postoperative hours
|
|
Postoperative Pain Scores (NRS)
Aikaikkuna: Postoperative 1st, 6th, 12th, 18th, and 24th hours
|
Postoperative pain intensity will be assessed using the Numeric Rating Scale (NRS) at rest (static) and during movement (dynamic).
(Scores range from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain)
|
Postoperative 1st, 6th, 12th, 18th, and 24th hours
|
|
Quality of Recovery-15 (QoR-15)
Aikaikkuna: 24 hours postoperatively
|
Postoperative recovery quality will be assessed using the Quality of Recovery-15 (QoR-15) questionnaire.
(Scores range from 0 to 150, where 0 indicates the worst possible recovery and 150 indicates the excellent/best possible recovery)
|
24 hours postoperatively
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- MTAPA-ESP-LC-SFT-2026-01
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .