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N/A N=72 Randomized Single-blind Supportive Care

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

Pain Management

Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Postoperative Pain Examination — 3; 5; 2; 3 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Group M-TAPA (Procedure); Group Serratus Intercostal Plane Block and Rectus Sheath Block (Procedure)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Hitit University
Primary completion
Apr 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Postoperative Pain Examination
3; 5; 2; 3; 2; 2
SECONDARY
Opioid Consumption
92.64; 103.9

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.

Eligibility Criteria

Inclusion Criteria

  • American Society of Anesthesiologists (ASA) classification with physical status 1-2
  • Between the ages of 18 and 65
  • 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
  • those undergoing a second procedure along with laparoscopic cholecystectomy
  • individuals with a history of abdominal surgery or trauma
  • conversion of laparoscopic surgery to open surgery
  • inability to communicate in Turkish
  • NRS score above 7 for consecutive 4 hours despite the planned multimodal analgesia regimen
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06241794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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