EOIB for Laparoscopic Cholecystectomy

Not Applicable

Recruiting

• Conditions: Cholecystitis; Cholecystitis, Acute; Cholecystitis, Chronic; Cholecystitis; Gallstone
• Interventions: Device: ultrasound guided external oblique intercostal plane block; Drug: Bupivacaine injection; Drug: paracetamol, tramadol, and ondansetron

• Registration Number: NCT06656299
• Lead Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

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.

Detailed Description

Despite the advancements in surgical and anesthesia techniques, pain following surgical interventions remains a significant issue concerning patient health and comfort today. The physiological response resulting from surgical trauma and stress can lead to various unwanted conditions in the pulmonary, cardiovascular, gastrointestinal, metabolic, and neuroendocrine systems. These complications negatively impact wound healing, length of hospital stay, and costs. The primary goal in managing pain after surgery is to facilitate the healing process, avoid potential side effects associated with analgesic treatments, and enhance patient comfort.

Cholecystectomy, which plays a significant role among abdominal surgical interventions, can currently be performed using two distinct techniques: open and laparoscopic.

Laparoscopic cholecystectomy is considered the gold standard treatment for symptomatic cholelithiasis due to its ability to cause less trauma compared to open surgery, facilitate faster recovery in patients, result in less postoperative pain, and allow patients to return to their normal lives more quickly.

There are three components of postoperative pain observed after laparoscopic cholecystectomy. These include somatic pain associated with the laparoscopic trocar entry incisions in the anterior abdominal wall, visceral pain due to pneumoperitoneum and surgical dissection of the gallbladder, and referred shoulder pain resulting from the stimulation of the phrenic nerve by residual carbon dioxide gas.

Effective management of postoperative pain is crucial for reducing respiratory complications, shortening hospital stay, and increasing patient satisfaction. In this context, both nonsteroidal intravenous analgesics and opioids are used. However, opioids have undesirable side effects, including respiratory depression, nausea and vomiting, and reduced gastrointestinal motility. Therefore, multimodal analgesia methods that combine intravenous analgesics with regional anesthesia are preferred, allowing for the reduction of drug-related side effects while providing safe and effective postoperative analgesia.

Interfascial plane blocks have been widely used for postoperative analgesia worldwide in recent years. When using long-acting local anesthetics and performed under ultrasound guidance, peripheral nerve blocks can be administered more easily, effectively, and reliably, providing analgesia for approximately 8 to 24 hours.

The External Oblique Intercostal Plane Block (EOIB) is one of the interfascial blocks used in upper abdominal surgeries. The local anesthetic is administered between the anterior axillary line and the midclavicular line, specifically in the fascia between the external oblique muscle and the sixth rib. Cadaver studies have demonstrated the spread of local anesthesia to the anterior cutaneous nerve at the T6-9 dermatomes and to the lateral cutaneous nerve at the T6-10 dermatomes. These studies suggest that the EOIB could be part of multimodal analgesia in upper and lateral abdominal surgeries. In this study, our hypothesis is that the EOIB may reduce the amount of opioids used in postoperative pain management, decrease opioid-related side effects, enhance patient comfort, and shorten the recovery process.

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-20
• Study First Submitted QC: 2024-10-23
• Study First Posted: 2024-10-24
• Study Start: 2024-10-30
• Last Update Submitted: 2024-10-30
• Last Update Posted: 2024-11-01
• Primary Completion: 2025-11-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Grup E (External Oblique Intercostal Plane Block)	ultrasound guided external oblique intercostal plane block	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).
Grup E (External Oblique Intercostal Plane Block)	paracetamol, tramadol, and ondansetron	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).
Grup T ( Trocar entry site infiltration)	Bupivacaine injection	After the trocar removed during the surgical procedure, the surgeon will administer 5 ml of 0.25% bupivacaine infiltration to each trocar entry site.
Grup T ( Trocar entry site infiltration)	paracetamol, tramadol, and ondansetron	After the trocar removed during the surgical procedure, the surgeon will administer 5 ml of 0.25% bupivacaine infiltration to each trocar entry site.

Primary Outcome Measures

Name	Time	Method
NRS (Numeric Rating Skore)	Postoperative 24 hours	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).

Secondary Outcome Measures

Name	Time	Method
Metoclopromide Consumption	Postoperative 24 hours	The severity of the nausea will be assessed on a 4 -point scale (0=none 1=mild, 2=moderate 3=severe). If the patients nausea score is ≥2 the patient will receive 10 mg metoclopromide.
Opioid Consumption	Postoperative 24 hours	First 24 hours total morphine consumption with patient controlled analgesia
Time to first rescue analgesic	Postoperative 24 hours	The time for administration of first rescue analgesic.
Adverse Events	Postoperative 24 hours	Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.
Quality of recovery levels between groups by using QoR-15 questionnaire	Postoperative 24 hours	A 15-parameter Quality of Recovery score (QoR-15) has been recommended as the optimum tool to evaluate overall patient-centers measures of recovery after surgery, including pain. It is a questionnaire that is given to patients to do postoperatively and is scored from 0 to 150 where 150 indicates that the patient has had an excellent recovery QoR-15 score will be recorded on the morning of operation and at the postoperative 24th hour

Trial Locations

Locations (1)

Sancaktepe Şehit Prof. Dr. İlhan Varank Training and Research Hospital; 🇹🇷 Istanbul, Turkey