The Efficacy of Thoracoabdominal Nerve Block With Serratus Intercostal Plane and Rectus Sheath Block in Cholecystectomy

NCT06241794 | Completed Results

• 1 other identifier: 2023-172
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Cholecystectomy is a widespread surgical procedure performed worldwide for acute cholecystitis. This operation can be performed using open surgery or laparoscopic techniques. Laparoscopic technique is superior to open surgery in terms of less pain at incision sites, shorter hospital stay, improved quality of life, and faster recovery times.However, despite being a minimally invasive surgery, laparoscopic cholecystectomy (LC) can still cause moderate to severe pain. Severe pain can lead to delayed postoperative ambulation, decreased patient satisfaction, the development of chronic pain, and is associated with increased lung and heart complications. Postoperative pain in LC can stem from various causes. To reduce the postoperative pain caused by LC, non-steroidal anti-inflammatory drugs, paracetamol, opioids, local anesthetics, and various regional anesthesia techniques are used.Multimodal analgesia has shown that the use of regional anesthesia and analgesia is crucial in reducing the neuroendocrine stress response in pain and trauma situations. The use of interfascial plane blocks performed under ultrasound guidance in LC surgery, considered easy and safe, has increased in recent years. The thoracoabdominal plane block (TAPA) applied through a perichondrial approach reaches a broader dermatomal area than the transversus abdominis plane (TAP) block and the oblique subcostal transversus abdominis plane (OSTAP) block.Serratus intercostal plane block (SIPB) has been found effective for somatic analgesia in a case series after gastrectomy and cholecystectomy surgeries. Subsequent studies have indicated the effectiveness of SIPB for open upper abdominal surgeries. Rectus sheath block (RSB) is used to provide postoperative analgesia after various surgeries, including laparoscopic and upper abdominal surgeries. Ultrasound-guided RSB in LC has significantly reduced postoperative pain.In this study, similar to the combination of RSB and SIPB was planned to be applied to enhance the effectiveness and quality of analgesia in the mid-abdomen. A group in LC surgery was administered bilateral M-TAPA, while another group received bilateral RSB + right SIPB, aiming to compare the postoperative analgesic effectiveness.

Conditions

Pain Management

Keywords

Laparoscopic Cholecystectomy; Modified Thoracoabdominal Plane Block; Serratus Intercostal Plane Block; Rectus Sheath Block

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Examination

  Determination of patients' post-operative pain level. The Numeric Rating Scale (NRS), a method that converts the patient's pain perception into a numerical form, will be used to assess postoperative pain. NRS has a numerical scale ranging from 0 to 10. The patient will rate the intensity of pain on a scale from 0, indicating no pain, to 10, representing the worst imaginable pain (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and \>8=intolerable pain). The NRS score will be evaluated both at rest and during active movement situations (such as transitioning from a lying to a sitting position). The Numeric Rating Scale (NRS): (NRS 0=no pain, 4=mild to moderate pain, 6-8=severe pain, and \>8=intolerable pain)

  24 hour

Secondary Outcomes (1)

• Opioid Consumption

  24 hour

Study Arms (2)

Group M-TAPA

ACTIVE COMPARATOR

M-TAPA: Aseptic conditions are ensured in the area where the block will be performed. Under ultrasound guidance, a linear probe at the sagittal plane and costochondral angle is used to identify the transversus abdominis, internal oblique, and external oblique muscles at the level of the 10th rib. To visualize the lower surface of the rib cartilage in the midline, a sagittal angle is applied with the probe in the direction of the costochondral angle at the edge of the 10th rib. Using a 22-G, 80-100 mm block needle with an in-plane technique, the needle is advanced cranially. The needle tip is directed towards the posterior surface of the 10th rib cartilage, underneath the condyle. Subsequently, 20 ml of 0.25% concentration bupivacaine is injected beneath the condyle. The same procedure will be applied to the opposite side using the same technique.

Procedure: Group M-TAPA

Group Serratus Intercostal Plane Block and Rectus Sheath Block

ACTIVE COMPARATOR

Serratus intercostal plane block:The serratus anterior muscle and intercostal muscles are identified at the level of 8th rib along the right mid-axillary line.Using block needle,20 ml of 0.25% Bupivacaine is injected into the interfascial plane between these muscles.The SIPB will be performed only on right side. Rectus sheath block:a linear probe is placed in a transverse position just above the umbilicus and slightly lateral to the midline.After visualizing the rectus abdominis muscle, posterior rectus sheath,and the hypoechoic space between them,block needle is advanced in-plane along the subcutaneous tissue.The needle is progressed until reaching the space between the epimysium of the muscle and the posterior rectus sheath, passing horizontally through the anterior rectus sheath of the rectus abdominis muscle.10 ml of 0.25% bupivacaine is injected.Adequate spread will lift the epimysium of the rectus abdominis muscle while displacing the posterior fascia and peritoneum downward

Procedure: Group Serratus Intercostal Plane Block and Rectus Sheath Block

Interventions

Group M-TAPA PROCEDURE

Aseptic conditions are ensured in the area where the block will be performed. Under ultrasound guidance, a linear probe at the sagittal plane and costochondral angle is used to identify the transversus abdominis, internal oblique, and external oblique muscles at the level of the 10th rib. To visualize the lower surface of the rib cartilage in the midline, a sagittal angle is applied with the probe in the direction of the costochondral angle at the edge of the 10th rib. Using a 22-G, 80-100 mm block needle with an in-plane technique, the needle is advanced cranially. The needle tip is directed towards the posterior surface of the 10th rib cartilage, underneath the condyle. Subsequently, 20 ml of 0.25% concentration bupivacaine is injected beneath the condyle. The same procedure will be applied to the opposite side using the same technique.

Group M-TAPA

Group Serratus Intercostal Plane Block and Rectus Sheath Block PROCEDURE

Serratus intercostal plane block:The serratus anterior muscle and intercostal muscles are identified at the level of 8th rib along the right mid-axillary line.Using block needle,20 ml of 0.25% Bupivacaine is injected into the interfascial plane between these muscles.The SIPB will be performed only on the right side. Rectus sheath block:a linear probe is placed in a transverse position just above the umbilicus and slightly lateral to the midline.After visualizing the rectus abdominis muscle, posterior rectus sheath,and the hypoechoic space between them,block needle is advanced in-plane along the subcutaneous tissue.The needle is progressed until reaching the space between the epimysium of the muscle and the posterior rectus sheath, passing horizontally through the anterior rectus sheath of the rectus abdominis muscle.10 ml of 0.25% bupivacaine is injected.Adequate spread will lift the epimysium of rectus abdominis muscle while displacing the posterior fascia and peritoneum downward

Group Serratus Intercostal Plane Block and Rectus Sheath Block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) classification with physical status 1-2
• Between the ages of 18 and 65
• Body Mass Index (BMI) \<35
• Has read and accepted the informed consent form voluntarily

You may not qualify if:

• The patient's unwillingness to participate in the study
• Patients with a body mass index (BMI) \>35
• ASA 3-5 classification
• unable to use the NRS pain scoring system
• allergies to the used local anesthetic and specified analgesic drugs
• individuals declaring pregnancy or breastfeeding
• patients under 18 or over 65 years of age
• those with uncontrolled anxiety
• alcohol and drug addiction
• neuromuscular and peripheral nerve diseases
• using high-dose opioid drugs three days before surgery
• hepatic and renal insufficiency, coagulation disorders
• diabetes mellitus
• patients using anticoagulant drugs
• infections at the site of peripheral block needle entry

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University Erol Olcok Training and Research Hospital

Çorum, Center, 19040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Guvenc Dogan
• Organization: Hitit University faculty of medicine

guvencdogan@gmail.com

06342193000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 5, 2024
• Study Start: February 5, 2024
• Primary Completion: April 30, 2024
• Study Completion: August 7, 2024
• Last Updated: March 3, 2025
• Results First Posted: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)