Effect of Transversus Abdominis Plan Block and Recto-Intercostal Fascial Plan Block in Laparoscopic Cholecystectomy

NCT06673524 | Completed

• 1 other identifier: 2024-103
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Cholecystectomy is a common surgical procedure performed globally for acute cholecystitis. Management of acute cholecystitis is divided into medical and surgical approaches. Medical management involves bed rest, analgesic agents, antibiotic therapy, and IV fluid replacement. Surgical management includes cholecystectomy, the removal of the gallbladder, which can be done via open surgery or laparoscopically. The laparoscopic approach has advantages over open surgery, such as reduced pain at incision sites, shorter hospital stays, improved quality of life, and faster recovery. However, despite its minimally invasive nature, laparoscopic cholecystectomy (LC) can still cause moderate to severe pain. Severe pain may delay ambulation, reduce patient satisfaction, lead to chronic pain, and increase the risk of pulmonary and cardiac complications. Postoperative pain in LC is multifactorial, primarily involving a combination of visceral, referred shoulder, and incisional pain. A multimodal analgesic approach is recommended for pain management. To alleviate LC-related postoperative pain, non-steroidal anti-inflammatory drugs, paracetamol, opioids, local anesthetics, and various regional anesthesia techniques are commonly employed. However, opioids may cause adverse effects, including nausea, vomiting, constipation, and respiratory depression. Neuraxial analgesia is seldom used in LC due to potential complications and technical difficulties. Regional anesthesia and multimodal analgesia have been shown to reduce the neuroendocrine stress response to pain and trauma effectively. Recently, the use of interfascial plane blocks under ultrasound guidance (USG), considered easy and safe, has increased in LC surgery. The TAP block, first described by Rafi in 2001 and later refined by McDonnell et al. in 2004 as a field block for abdominal surgeries, provides analgesia by blocking the 7th-11th intercostal nerves (T7-T11), the subcostal nerve (T12), and the ilioinguinal (IIN) and iliohypogastric nerves (IHN) (L1-L2). Hebbard et al. later described an ultrasound-guided approach to the TAP block. The recto-intercostal fascial plane block (RIFPB) was introduced in 2023 by Tulgar et al. as an alternative to parasternal intercostal blocks for parasternal surgeries and is reported to block almost the entire upper abdomen. In a case series by Ömür et al., RIFPB was shown to provide both lower sternal and epigastric blockade and sensory block across the upper anterolateral abdomen.

Conditions

Postoperative Pain

Keywords

Cholecystectomy; Pain; Postoperative; Transversus Abdominis Plan Block; Recto-Intercostal Fascial Plan Block

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Examination with Numeric Rating Scale

  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).

  24 hours

Study Arms (2)

Group T (Transversus Abmoninis Plane Block)

ACTIVE COMPARATOR

TAP Block: Aseptic conditions are ensured in the area where the block will be performed. With the patient in the supine position, the ultrasound (USG) probe is placed in an oblique position lateral to the xiphoid process at the lower border of the rib cage. The rectus abdominis muscle and its posterior sheath are visualized above the transversus abdominis muscle. At this level, only the aponeurosis of the internal oblique muscle can be seen between the transversus and external oblique muscles. By applying some pressure and tilt to the probe, the image of the myofascial planes is better optimized. Using a 22-25G, 50-100 mm block needle, an in-plane technique is applied, advancing either medially to laterally or vice versa. In the fascial plane between the rectus abdominis and transversus abdominis or between the internal oblique and transversus abdominis muscles, 20 ml of 0.25% bupivacaine is injected. The same procedure is then applied to the opposite side.

Procedure: Group T (Transversus Abmoninis Plane Block)

Group R (Rectus-Intercostal Fascial Plane Block)

ACTIVE COMPARATOR

Rectus-Intercostal Fascial Plane Block: Aseptic conditions are ensured in the area where the block will be performed. With the patient in the supine position and under ultrasound (USG) guidance, a linear probe is placed 2-3 cm lateral and caudal to the xiphoid process to visualize the rectus abdominis muscle and the 6th-7th costal cartilages. Using an in-plane technique, the needle is advanced from caudal to cephalad. After confirming the target by hydrodissecting between the ribs and the rectus abdominis muscle, 20 ml of 0.25% bupivacaine is injected into the interfascial plane between the 6th-7th ribs and the rectus abdominis muscle using a 22-G, 80 mm block needle. The same procedure is then applied to the opposite side.

Procedure: Group R (Rectus-Intercostal Fascial Plane Block)

Interventions

Group T (Transversus Abmoninis Plane Block) PROCEDURE

TAP Block: Aseptic conditions are ensured in the area where the block will be performed. With the patient in the supine position, the ultrasound (USG) probe is placed in an oblique position lateral to the xiphoid process at the lower border of the rib cage. The rectus abdominis muscle and its posterior sheath are visualized above the transversus abdominis muscle. At this level, only the aponeurosis of the internal oblique muscle can be seen between the transversus and external oblique muscles. By applying some pressure and tilt to the probe, the image of the myofascial planes is better optimized. Using a 22-25G, 50-100 mm block needle, an in-plane technique is applied, advancing either medially to laterally or vice versa. In the fascial plane between the rectus abdominis and transversus abdominis or between the internal oblique and transversus abdominis muscles, 20 ml of 0.25% bupivacaine is injected. The same procedure is then applied to the opposite side.

Group T (Transversus Abmoninis Plane Block)

Group R (Rectus-Intercostal Fascial Plane Block) PROCEDURE

Rectus-Intercostal Fascial Plane Block: Aseptic conditions are ensured in the area where the block will be performed. With the patient in the supine position and under ultrasound (USG) guidance, a linear probe is placed 2-3 cm lateral and caudal to the xiphoid process to visualize the rectus abdominis muscle and the 6th-7th costal cartilages. Using an in-plane technique, the needle is advanced from caudal to cephalad. After confirming the target by hydrodissecting between the ribs and the rectus abdominis muscle, 20 ml of 0.25% bupivacaine is injected into the interfascial plane between the 6th-7th ribs and the rectus abdominis muscle using a 22-G, 80 mm block needle. The same procedure is then applied to the opposite side.

Group R (Rectus-Intercostal Fascial Plane 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:

• Will undergo Cholecystectomy surgery
• The American Society of Anesthesiologists (ASA) physical classification is 1-2.
• The volunteer has read and accepted the consent form
• Body mass index (BMI) \<35

You may not qualify if:

• The patient does not want to participate in the study
• Patients with BMI \>35
• Patients with ASA 3-4-5
• Those who are allergic to the local anesthetic used and the specified analgesic drug
• Those who declare that they are during pregnancy and breastfeeding
• Having uncontrollable anxiety
• Those with neuromuscular disease and peripheral nerve diseaseThose who used high doses of opioid medication 3 days before surgery
• Widespread chronic pain, diabetes mellitus, hepatic and renal failure
• Infection at the peripheral block needle insertion site

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University Erol Olcok Training and Research Hospital

Çorum, 19200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Pain

Interventions

Sensitivity Training Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy, Group; Socioenvironmental Therapy; Psychotherapy; Behavioral Disciplines and Activities

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: Associate Professor

Model Details: TAP Block: Aseptic conditions are established. With the patient supine, the ultrasound (USG) probe is placed laterally to the xiphoid process at the rib cage's lower border, visualizing the rectus abdominis above the transversus abdominis. The internal oblique aponeurosis is seen between the transversus and external oblique muscles. Pressure is applied to optimize myofascial plane visualization. A 22-25G, 50-100 mm block needle is used in an in-plane technique to inject 20 ml of 0.25% bupivacaine in the fascial plane between the rectus and transversus abdominis, then repeated on the opposite side. Rectus-Intercostal Fascial Plane Block: With the patient supine under USG, a probe is placed 2-3 cm lateral to the xiphoid process to visualize the rectus abdominis and 6th-7th costal cartilages. A needle is advanced to inject 20 ml of 0.25% bupivacaine into the interfascial plane, repeated on the opposite side.

Study Record Dates

• First Submitted: November 2, 2024
• First Posted: November 5, 2024
• Study Start: November 10, 2024
• Primary Completion: January 20, 2025
• Study Completion: March 25, 2025
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

TU (1)