Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy.

Ultrasound-guided Bilateral External Oblique İntercostal (EOI) Plane Block in Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Controlled Trial

This study will define the postoperative analgesic effect of ultrasound-guided bilateral External Oblique İntercostal (EOI) Plane Block and compare the control group in patients undergoing laparoscopic cholecystectomy.

The aim of this study is to compare postoperative opioid consumption of EOI plane block versus control group. It is hypothesized that postoperative opioid use will be less in patients with EOI plane block than in patients who only receive routine multimodal analgesia.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Other: Bilateral External Oblique İntercostal (EOI) Plane Block; Other: Standard perioperative and postoperative multimodal analgesia

Detailed Description

Laparoscopy is a minimally invasive procedure, but postoperative pain is still the most common symptom after laparoscopic cholecystectomy (LC). Regional blocks used in addition to multimodal analgesia for postoperative pain after LC usually block the anterior branches of the intercostal nerves. After it was suggested by Hamilton et al. in 2018 that it could block the lateral cutaneous branches between T7-T11 intercostal nerve by administering local anesthetic to the thoracic facial plane and could be used in lateral abdominal surgeries, the EOI plane block has become a block that can be used for analgesic purposes in upper and lateral abdominal surgeries. Blocking the anterior and lateral branches together may produce analgesia in a wider area, resulting in less postoperative opioid consumption.

This study will be conducted as a single-center, prospective, randomized trial in a university hospital. Patients scheduled for elective laparoscopic cholecystectomy will be screened for enrollment in the study. After randomization, EOI Plane Block will be performed under ultrasound guidance after administering general anesthesia and prior to the skin incision. An anesthesiologist who performed blocks will not involve in the data collection. Other health care workers who will involve in the evaluation of postoperative opioid consumption,pain scores, nausea and vomiting, antiemetic use, and Quality of Recovery score will be blinded to group assignment.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Taining and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients' age between 18 and 70 years with American Society of Anesthesiology (ASA) physical status I-II, who will be scheduled for an elective laparoscopic cholecystectomy surgery included in the study.

Exclusion Criteria:

• presence of coagulation disorder
• infection at the injection site of the block
• known allergy to local anesthetics
• advanced hepatic or renal failure
• can not communicate in Turkish
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (EOI) Plane Block; After tracheal intubation, a high-frequency linear probe will be in a cephalad to caudad paramedian direction at the anterior axillary line, and the external oblique muscle identified at the level ribs 6 and 7 in line. A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to EOI plane. The same procedure will be repeated on the contralateral side. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.	Other: Bilateral External Oblique İntercostal (EOI) Plane Block; External Oblique İntercostal (EOI) Plane Block will be provided for postoperative pain for Laparoscopic Cholecystectomy with Bupivacaine. And patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.; Other Names: Standard Pain Followup and Monitorization; Quality of Recovery-15 score
Sham Comparator: Group N; The patients in Group N will not receive any intervention. In the intervention and control groups, block sites will be covered with dressings, and patients and other health care workers will be blinded to treatment allocation. Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol.	Other: Standard perioperative and postoperative multimodal analgesia; Patients will receive standard multimodal analgesia comprising paracetamol, deksketoprofen, and tramadol for Laparoscopic Cholecystectomy.; Other Names: Standard Pain Followup and Monitorization; Quality of Recovery-15 score

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	If NRS score of the patient is equal or over 4, IV 50 mg tramadol will be applied as a rescue analgesic.	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first rescue analgesic	The time for administration of first rescue analgesic.	Postoperative 24 hours
Sedation score	Sedation level of the patients will be assessed on a 4-point scale (0=alert, 1=sleepy, easy to arouse verbally, 2= drowsy, 3=does not open eyes to verbal commands) at postoperative 15th,30th and 60th minute, second, 6th, 12th and 24th hour.	Postoperative 24 hour
Quality of recovery levels between groups by using QoR-15 questionnaire	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.	Postoperative 24th hour
Numerical Rating Scale scores	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
Adverse events	Incidence of nausea and vomiting during postoperative 24 hour time period will be noted.	Postoperative 24 hours
Metoclopromide consumption	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.	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Karaman Training and Research Hospital
• Investigators: Study Chair: Muhammet Korkusuz, MD, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Actual): November 23, 2022
• Study Completion (Actual): November 24, 2022

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 9, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopic Cholecystectomy; Nerve block; Acute Postoperative Pain
• Other Study ID Numbers: 02-2022/11

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No