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

NCT06673524 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-03-30

No results posted yet for this study

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

Interventions

PROCEDURE

Group T (Transversus Abmoninis Plane Block)

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 R (Rectus-Intercostal Fascial Plane Block)

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.

Sponsors & Collaborators

  • Hitit University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-10
Primary Completion
2025-01-20
Completion
2025-03-25

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06673524 on ClinicalTrials.gov