Postoperative Pain Management in Laparoscopic Cholecystectomies

Comparison of External Oblique Intercostal Plane Block Oblique Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration Methods in Laparoscopic Cholecystectomies

This study is to demonstrate the effectiveness of external oblique intercostal plane block, a new block method, in the treatment of postoperative pain occurring after laparoscopic cholecystectomy operations, which are frequently and widely performed today.

It aims to add new applications to multimodal analgesia methods, which provide the greatest contribution to the early recovery process after surgery, and to contribute to the early recovery process by increasing patient satisfaction.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain; Regional Anesthesia
• Intervention / Treatment: Procedure: unilateral external oblique intercostal plane block group; Procedure: unilateral oblique subcostal transversus abdomınıs plane block group; Procedure: Local anesthetic infiltration group; Drug: Control group

Detailed Description

Postoperative pain is an acute pain that begins with surgical trauma and gradually decreases with tissue healing, and its elimination is important for ideal patient care after surgery. Postoperative pain; It varies depending on the type of surgery, the patient, and the need and type of analgesic in the intraoperative period. Although there have been new developments in recent years to relieve postoperative pain, studies have shown that 25% of patients can receive adequate postoperative pain treatment.The increase in thromboembolic, cardiac and respiratory complications caused by untreatable postoperative pain is one of the most important problems in operated patients.

Laparoscopic cholecystectomy; It is one of the most frequently performed surgical procedures in adult patients, and different types of pain such as parietal, visceral and somatic (shoulder pain) can be observed due to tissue damage after laparoscopic cholecystectomy, postoperative pain, diaphragmatic irritation and residual pneumoperitoneum.Multimodal analgesia in laparoscopic cholecystectomies; It can be provided with combinations of regional anesthesia techniques, incision site local anesthetic applications, intravenous opioids, nonsteroidal anti-inflammatory drugs, paracetamol and preemptive analgesia methods.

Regional anesthesia techniques have become more popular recently for the purpose of postoperative pain control, and regional anesthesia techniques in laparoscopic cholecystectomy such as epidural block, paravertebral block, transversus abdominis plan (TAP) block and External Oblique Intercostal Plan (EOIP) block, whose effectiveness has been shown by new studies. Includes methods.

Oblique subcostal transversus abdominis plane (OSTAP) block is a regional anesthesia technique defined as a modified version of the TAP block used especially in upper abdominal surgeries such as Laparoscopic cholecystectomy.EOIP block is a new regional anesthesia technique that can provide analgesia in the postoperative period in upper abdominal abdominal surgery, which was demonstrated by anatomical studies in 2021.

EOIP block, the spread of regional anesthesia to the lateral and anterior cutaneous branches of T6/7 and T10/11, the origin of the intercostal nerves, constitutes the mechanism of this technique and shows that Laparoscopic cholecystectomies can be effective in postoperative analgesia management.

Regional anesthesia methods are frequently used in our clinic for patients undergoing upper abdominal surgery for analgesia. In this study, the investigators aimed to compare the EOIP block, OSTAP block and local anesthetic infiltration methods in laparoscopic cholecystectomy in terms of pain effectiveness in the postoperative period.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06100
    • Ankara Bılkent City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• age 18-65
• Patients undergoing elective laparoscopic cholecystectomy
• American Society of Anesthesiologists score 1-2 patients
• Body mass index ) <35kg/m2
• Patients whose consent was obtained before the procedure

Exclusion Criteria:

• Patients under the age of 18 and over the age of 65
• American Society of Anesthesiologists score III and above
• Surgeries with an operating time exceeding 120 minutes
• Emergency surgeries
• Those who have had abdominal surgery
• Pregnant or breastfeeding patients
• Those who have coagulopathy and use anticoagulant drugs
• Those who are allergic to local anesthetics
• Those with localized infection at the injection site
• Patients who do not have the ability to use patient controlled analgesia and evaluate Numerical rating scale
• Patients with peripheral nerve disease
• Patients with renal failure and congestive heart failure
• Patients undergoing elective laparoscopic cholecystectomy due to malignancy
• Surgeries where open surgery is performed during the operation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: External oblique intercostal plane block group; Before general anaesthesia, Ultrasound guided unilateral external oblique intercostal plane block group block will perform with 20 ml of 0.25% bupivacaine .Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours.	Procedure: unilateral external oblique intercostal plane block group; USG guided external oblique intercostal plane block will perform unilateral with Bupivacaine 25 patient included and patients were observed for pain for 24 hours
Active Comparator: Oblique subcostal transversus abdomınıs plane block group; Under general anaesthesia, Ultrasound guided unilateral oblique subcostal transversus abdomınıs plane block will perform with 20 ml of 0.25% bupivacaine. Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours	Procedure: unilateral oblique subcostal transversus abdomınıs plane block group; USG guided oblique subcostal transversus abdomınıs plane block block will perform unilateral with Bupivacaine. 25 patient included and patients were observed for pain for 24 hours
Active Comparator: Local anesthetic infiltration group; 4 trocars will be used by the surgical team during the operation, and these trocars will be placed 10 mm infraumbilical, 10 mm in the middle epigastrium, 5 cm below the xiphoid, 5 mm in the midclavicular line and in the right subcostal region, and 5 mm in the anterior axillary line. Before trocar placement, 0.25% bupivacaine will be applied to the skin, fascia, muscle and preperitoneal area in accordance with the infiltration rules. A total of 20 mL of 0.25% bupivacaine will be used, 6 mL for 10 mm trocar sites and 4 mL for 5 mm trocar sites. Patient controlled analgesia with tramadol will apply to the all patients. Postoperative pain assessment and opioid consumption will record till the postoperative 24 th hours	Procedure: Local anesthetic infiltration group; Bupivacaine infiltration will be performed to trocar insertion sites. 25 patient included and patients were observed for pain for 24 hours
Sham Comparator: Control Group; All patients were followed using a standardized postoperative analgesia protocol which includes tramadol patient controlled analgesia. Tramadol at a concentration of 5 mg/mL is included in our patient controlled analgesia protocol (total volume 100 mL.) Patient controlled analgesia protocols were set to no basal infusion and 10 mg bolus doses with a 20 min lock time 25 patient included and patients were observed for pain for 24 hours	Drug: Control group; All patients were followed using a standardized postoperative analgesia protocol which includes tramadol patient controlled analgesia. Tramadol at a concentration of 5 mg/mL is included in our patient controlled analgesia protocol (total volume 100 mL.) patient controlled analgesias were set to no basal infusion and 10 mg bolus doses with a 20 min lock time 25 patient included and patients were observed for pain for 24 hours; Other Names: intravenous patient controlled analgesia group with tramadol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of postoperative opioid use	Patient controlled analgesia (PCA) will provide with tramadol PCA. Total tramadol consumption will calculate and record till the postoperative 24th hours	24 hours
Finding out which method is more effective according to the Numerical Rating Scale (0-10)	To find out which method provides more effective analgesia according to the Numeric Rating Scale patients followed for 24 hours. A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. 0 is no pain and 10 is the worst pain	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative nause and vomiting	The patient with nausea and vomiting will be recorded postoperative nausea and vomiting; will be evaluated as present or absent	24 hours
postoperative shoulder pain	The patient with shoulder pain will be recorded postoperative shoulder pain; will be evaluated as present or absent	24 hours

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Principal Investigator: Buğra Kurtoğlu, MD, Ankara Bilkent City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Estimated): September 20, 2024
• Study Completion (Estimated): October 20, 2024

Study Registration Dates

• First Submitted: March 17, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: analgesia; postoperative pain; laparoscopic cholecystectomy; regional anesthesia; external oblique intercostal plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Anesthetics, Local; Tramadol
• Other Study ID Numbers: ACHBILKENT-ANEST-BK-01

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
• product manufactured in and exported from the U.S.: No