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Comparison of M-TAPA and ESPB for Postoperative Pulmonary Function After Laparoscopic Cholecystectomy

18. juni 2026 opdateret af: Muhammed Nail Tekcan, Kayseri City Hospital

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Muhammed N Tekcan, Anesthesiology and Reanimation
  • Telefonnummer: +905387931833
  • E-mail: mntekcan@gmail.com

Studiesteder

  • Tyrkiet (Türkiye)
    • Kocasinan
      • Kayseri, Kocasinan, Tyrkiet (Türkiye), 38080
        • Kayseri City Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: Modified thoracoabdominal nerve block through the perichondrial approach (M-TAPA)
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.
Eksperimentel: Erector spinae plane block (ESPB)
An ultrasound-guided erector spinae plane block (ESPB) performed with local anesthetic for postoperative analgesia after laparoscopic cholecystectomy.
Procedure: Erector spinae plane block (ESPB)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Forced Expiratory Volume in 1 Second (FEV1)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total Opioid Consumption
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kayseri City Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. januar 2027

Studieafslutning (Anslået)

1. marts 2027

Datoer for studieregistrering

Først indsendt

15. juni 2026

Først indsendt, der opfyldte QC-kriterier

18. juni 2026

Først opslået (Faktiske)

24. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • MTAPA-ESP-LC-SFT-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

Anonymized participant-level data, including demographic variables, pulmonary function tests, pain scores, opioid consumption, and QoR-15 outcomes, may be shared upon reasonable request.

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