This randomized clinical trial aims to evaluate and compare the analgesicefficacy of theIntertransverse Process Block (ITPB) and the Modified Thoracoabdominal Nerve Blockthrough Perichondrial Approach (M-TAPA) in patients undergoing laparoscopic hysterectomy.The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hoursafter surgery. Secondary outcomes include total opioid consumption, requirement forrescue analgesia, block- related complications and adverse effects (hematoma,pneumothorax, local anesthetic systemic complications, vascular puncture, and infection),patient satisfaction assessed using a Likert scale, quality of recovery assessed usingthe QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.
Study Objective: This research aims to obtain objective data to demonstrate the
effectiveness of two regional block techniques in acute pain management. The primary
objective is to compare the effects of Intertransverse Process Block (ITPB) and M-TAPA
Block on Visual Analog Scale (VAS) scores in patients undergoing laparoscopic
hysterectomy. Secondary outcomes include evaluating the impact of these blocks on total
opioid consumption within the first 24 hours, requirement for rescue analgesia,
block-related and systemic complications (hematoma, pneumothorax, local anesthetic
systemic toxicity, vascular puncture, infection), patient satisfaction assessed using a
Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence
of postoperative nausea and vomiting.Materials and Methods: This prospective, randomized
clinical study will include voluntary patients aged 18-65 years, classified as American
Society of Anesthesiologists (ASA) physical status I-III, with a body mass index (BMI)
18-35 kg/m². All participants will be informed about the study protocol in detail, and
written informed consent will be obtained prior to inclusion. Patients will receive
instruction on the use of the VAS for pain assessment, where 0 denotes no pain and 10
denotes the worst imaginable pain. Patients who meet the exclusion criteria will be
withdrawn from the study. Participants will be randomly assigned to one of two groups
using a computer-generated simple randomization method (https://www.randomizer.org).
Randomization will be performed by a team member uninvolved in patient care, who will
also prepare sealed opaque envelopes to conceal group allocation until shortly before
block administration.Study Groups and Block Procedures: Group ITP will receive a
bilateral ITP block, and Group M-TAPA will receive a bilateral M-TAPA block. All patients
will be monitored with electrocardiography, peripheral oxygen saturation (SpO2), and
non-invasive blood pressure prior to the block. Premedication with intravenous midazolam
(0.02 mg/kg) will be administered.ITP Block :Intertransverse Process Block (ITP) will be
performed 30 minutes prior to surgery with the patient in a sitting position. After skin
disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized
using 2-4 mL of 1% lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear
ultrasound probe (Mindray Diagnostic Ultrasound System, Model DC-T6) will be positioned
along the medial border of spinous processes level of the T10 thoracic
vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse
processes, and superior costotransverse ligament complex at the T10 level, will be
identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle
(Echoplex®+ , Vygon SA, Écouen, France) will be inserted through the erector spinae
muscle toward the intertransverse tissue complex located between the superior
costotransverse ligament and the transverse processes. Proper needle placement will be
confirmed with the injection of 1-2 mL isotonic saline demonstrating separation within
the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25%
bupivacaine hydrochloride (Buvasin®, Vem Pharmaceuticals, Turkey) will be administered on
each side under ultrasound guidance.M-TAPA Block:The Block will be performed 30 minutes
prior to surgery with the patient in a supine position. After skin disinfection with
chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1%
lidocaine (Aritmal®, Osel Pharmaceuticals, Turkey). A linear ultrasound probe (Mindray
Diagnostic Ultrasound System, Model DC-T6) will be positioned obliquely along the costal
margin at the level of the 10th costal cartilage.Anatomical landmarks, including the
costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal
oblique muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic
insulated needle (Echoplex®+ , Vygon SA, Écouen, France) will be inserted toward the
perichondrial plane beneath the 10th costal cartilage under ultrasound guidance. Proper
needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon
confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride (Buvasin®,
Vem Pharmaceuticals, Turkey) will be administered on each side under ultrasound
guidance.General Anesthesia Upon entry into the operating room, patients will be
monitored with electrocardiography, peripheral oxygen saturation (SpO#), and non-invasive
blood pressure. Anesthesia will be induced with intravenous propofol (2 mg/kg, Polifarma
Pharmaceutical Industry and Trade Inc., Ergene, Turkey), fentanyl citrate (1.5 mcg/kg,
Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey), and rocuronium bromide
(0.6 mg/kg, Muscuron®, Koçak Farma Pharmaceutical and Chemical Industry Co., Turkey).
Anesthesia maintenance will be provided using 6% desflurane in a 40%oxygen-air mixture
and a continuous remifentanil infusion at 0.05 mcg/kg/min. Mechanical ventilation
settings will be adjusted to deliver a tidal volume of 6-8 mL/kg with end-tidal CO#
maintained at 30-35 mmHg. Anesthetic depth will be monitored continuously using a
Bispectral Index (BIS™) monitor (Medtronic plc, Dublin, Ireland), targeting a BIS value
of 40-60. If heart rate or mean arterial pressure increases >20% from baseline, the
remifentanil dose will be titrated accordingly.Thirty minutes before the end of surgery,
all patients will receive 15 mg/kg of intravenous paracetamol (e.g., Paracerol®,
Polifarma Pharmaceutical Industry and Trade Inc., Ergene, Turkey) and 1 mg/kg of
intravenous tramadol. To prevent nausea and vomiting, 4 mg intravenous ondansetron will
be administered. Patients with adequate spontaneous ventilation will be extubated and
transferred to the post-anesthesia care unit (PACU). Hemodynamic Monitoring Heart rate,
systolic blood pressure, diastolic blood pressure, mean arterial pressure, and oxygen
saturation will be recorded at the following time points: pre-induction (baseline), 5
minutes after induction, 5 minutes after surgical incision, 15 minutes after incision,
and at the end of surgery.Postoperative Pain and Analgesic Use: Pain will be assessed
using the VAS at rest (static) and during movement (dynamic) at 0, 1, 4, 8, 12, and 24
hours postoperatively.All patients will use patient-controlled analgesia (PCA) without a
basal infusion. The PCA device will be set to deliver 1 mg of morphine (0.2 mg/mL
concentration) with a 10-minute lockout interval. Patients will be instructed to press
the PCA button when VAS ≥4. Intravenous paracetamol will be administered every 8 hours.
Rescue analgesia with intravenous tramadol (1 mg/kg) will be provided if VAS scores
remain ≥4. The total amounts of opioids, NSAIDs, and other analgesics will be
recorded.Postoperative Recovery Quality Postoperative recovery will be assessed using the
15-item Quality of Recovery-15 (QoR-15) questionnaire, which evaluates five domains:
pain, physical comfort, physical independence, psychological support, and emotional
state.Patient Satisfaction Satisfaction will be evaluated using a 5-pointLikert scale,
where 1 = not satisfied and 5 = very satisfied, based on verbalfeedback from both the
patient and the surgeon.Nausea and Vomiting: Nausea and vomiting will be scored using a
4-point scale:0 = none1. = mild2. = moderate3. = severe Potential Complications Any
complications associated withthe block or the surgical procedure (e.g., hematoma,
pneumothorax,local anesthetic systemic toxicity, vascular puncture, or infection) will
berecorded.
Procedure: Intertransverse Process Block
A linear ultrasound probe will be positioned along the medial border of spinous processes
level of the T10 thoracic vertebrae.Anatomical landmarks, including the erector spinae
muscle, transverse processes, and superior costotransverse ligament complex at the T10
level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic
insulated needle will be inserted through the erector spinae muscle toward the
intertransverse tissue complex located between the superior costotransverse ligament and
the transverse processes. Proper needle placement will be confirmed with the injection of
1-2 mmL isotonic saline demonstrating separation within the intertransverse plane. Upon
confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be
administered on each side under ultrasound guidance.
Procedure: M-TAPA Block
A linear ultrasound probe will be positioned obliquely along the costal margin at the
level of the 10th costal cartilage. Anatomical landmarks, including the costal cartilage,
rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will
be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle
will be inserted toward the perichondrial plane beneath the 10th costal cartilage under
ultrasound guidance. Proper needle placement will be confirmed with the injection of 1-2
mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine
hydrochloride will be administered on each side under ultrasound guidance.
Inclusion Criteria:
- Patients aged 18-65 years
- ASA physical status I-III
- Scheduled for elective laparoscopic hysterectomy
- Body mass index (BMI) 18-35 kg/m²
- Ability to understand and use the patient-controlled analgesia (PCA) device
- Ability to provide written informed consent
Exclusion Criteria:
- Refusal to participate
- Allergy to local anesthetics
- Infection at the injection site
- Coagulopathy or ongoing anticoagulant therapy
- Chronic opioid use or opioid dependence
- Severe hepatic or renal insufficiency
- Pregnancy or breastfeeding
- Cognitive impairment or inability to communicate pain scores
- Body mass index (BMI) >35 kg/m²
Not Provided
Beste Mutlu Dağlıoğlu
+905546892608
drbeste.bm@gmail.com
Not Provided