EOIB for Laparoscopic Cholecystectomy

NCT06656299 | Recruiting

• 1 other identifier: EOIB
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic cholecystectomy, while less painful compared to conventional methods, is still a surgery that can cause significant pain for patients. Preventing postoperative pain is crucial for reducing respiratory complications, shortening hospital stays, and increasing patient satisfaction. Interfascial plane blocks have been widely used for postoperative analgesia in recent years worldwide. The External Oblique Intercostal Plane Block is one of the interfascial plane blocks used in abdominal surgeries. In our study, we aimed to compare the postoperative pain scores of patients who underwent laparoscopic cholecystectomy under general anesthesia, specifically between those who received the external oblique intercostal plane block and those who had trocar entry site infiltration.

Conditions

Cholecystitis; Cholecystitis, Acute; Cholecystitis, Chronic; Cholecystitis; Gallstone

Keywords

External Oblique Intercostal Plan Block; Wound Infiltration; Laparoscopic Cholecystectomy; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• NRS (Numeric Rating Skore)

  The primary outcome variable is Numerical Rating Scale scores both at rest and motion. A blinded anesthesiologist will assess postoperative pain during rest and motion at the postoperative 15th,30th and 60th minute, second,6th, 12th and 24th hour by using 11-point Numerical Rating Scale which ranges from '0' (means no pain) to '10' (means worst pain imaginable).

  Postoperative 24 hours

Secondary Outcomes (5)

• Opioid Consumption

  Postoperative 24 hours

• Time to first rescue analgesic

  Postoperative 24 hours

• Adverse Events

  Postoperative 24 hours

• Metoclopromide Consumption

  Postoperative 24 hours

• Quality of recovery levels between groups by using QoR-15 questionnaire

  Postoperative 24 hours

Study Arms (2)

Grup E (External Oblique Intercostal Plane Block)

ACTIVE COMPARATOR

At the end of the surgical procedure,a high-frequency linear probe will be sterilely covered,and an 80mm block needle will be used for the procedure.Under sterile conditions,the ultrasound probe will be placed in a parasagittal position in the area between the anterior axillary line and the midclavicular line at the level of the 10th rib, and then slid cranially along the longitudinal axis to the level of the 6th and 7th ribs. After visualizing the external oblique muscle, the block needle will be inserted using an in-plane technique,and 5ml of saline will be administered to confirm the location at the external oblique intercostal plane between the external oblique muscle and the 6th rib. Once the location is confirmed, 20cc of 0.25%bupivacaine will be infiltrated into the EOIP. The same procedure will be applied to the opposite side (totally 40 ml).

Device: ultrasound guided external oblique intercostal plane block; Drug: paracetamol, tramadol, and ondansetron

Grup T ( Trocar entry site infiltration)

OTHER

After the trocar removed during the surgical procedure, the surgeon will administer 5 ml of 0.25% bupivacaine infiltration to each trocar entry site.

Drug: Bupivacaine injection; Drug: paracetamol, tramadol, and ondansetron

Interventions

ultrasound guided external oblique intercostal plane block DEVICE

ultrasound guided external oblique intercostal plane block

Grup E (External Oblique Intercostal Plane Block)

Bupivacaine injection DRUG

5 ml local anesthetic for each trocar sides

Also known as: Local anesthetic injection

Grup T ( Trocar entry site infiltration)

paracetamol, tramadol, and ondansetron DRUG

As standard multimodal analgesia, 20 min before the end of the surgery patients will receive 1 g of paracetamol, 1-2 mg/kg of tramadol, and 4 mg of ondansetron via intravenous infusion. All patients will be recovered in the PACU, and after confirming an Aldrete score of \>9, a PCA (patient-controlled analgesia) device will be installed with morphine prepared at a dose appropriate for the patient's age. Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. When patients have a Numerical Rating Scale (NRS) score is ≥ 4, 1 mg/kg iv tramadol will be administered as a rescue analgesic

Grup E (External Oblique Intercostal Plane Block); Grup T ( Trocar entry site infiltration)

Eligibility Criteria

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

You may qualify if:

• Patients aged 18 to 65 who will be scheduled for an elective laparoscopic cholecystectomy under general anesthesia
• ASA (American Society of Anesthesiologists) I-II-III

You may not qualify if:

• presence of coagulation disorder
• infection at the injection site of the block
• known allergy to local anesthetics
• advanced hepatic, heart or renal failure
• history of abdominal surgery or trauma
• conversion of laparoscopic to open surgery
• consumption of any pain killers within the 24 h before the operation
• chronic opioid consumption
• pregnancy
• alcohol or drug abuse
• body mass index (BMI) ≥ 35 kg m-2
• Impairment of the patient's cognitive functions (such as Alzheimer's disease, dementia, etc.).
• Cholecystectomy cases performed under emergency conditions.

Sponsors & Collaborators

• Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital: lead

Study Sites (1)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Yildirim H. Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Saudi Med J. 2023 Oct;44(10):1037-1046. doi: 10.15537/smj.2023.44.10.20230350.

  PMID: 37777270 BACKGROUND

• Doymus O, Ahiskalioglu A, Kaciroglu A, Bedir Z, Tayar S, Yeni M, Karadeniz E. External Oblique Intercostal Plane Block Versus Port-Site Infiltration for Laparoscopic Sleeve Gastrectomy: A Randomized Controlled Study. Obes Surg. 2024 May;34(5):1826-1833. doi: 10.1007/s11695-024-07219-z. Epub 2024 Apr 2.

  PMID: 38565828 BACKGROUND

• Mehmet Selim C, Halide S, Erkan Cem C, Onur K, Sedat H, Senem U. Efficacy of Unilateral External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block in Laparoscopic Cholecystectomy: Randomized, Prospective Study. Surg Innov. 2024 Aug;31(4):381-388. doi: 10.1177/15533506241256529. Epub 2024 May 23.

  PMID: 38780355 BACKGROUND

MeSH Terms

Conditions

Cholecystitis; Cholecystitis, Acute; Bronchiolitis Obliterans Syndrome; Gallstones; Pain, Postoperative

Interventions

Bupivacaine; Anesthetics, Local; Acetaminophen; Tramadol; Ondansetron

Condition Hierarchy (Ancestors)

Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases; Cholelithiasis; Cholecystolithiasis; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Acetanilides; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Dimethylamines; Methylamines; Lipids; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and outcomes assessor wil be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: There are two groups for this study

Study Record Dates

• First Submitted: October 20, 2024
• First Posted: October 24, 2024
• Study Start: October 30, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)