Postoperative Pain Management in Laparoscopic Cholecystectomies

Cholecystitis/Cholelithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06326281
• Other study ID #: ACHBILKENT-ANEST-BK-01
• Status: Completed
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: March 2024
• Source: Ankara City Hospital Bilkent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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, we 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 28, 2024
• Est. primary completion date: February 22, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 Visual analogue scala
• 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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis/Cholelithiasis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Other:
• external oblique intercostal plane block group
25 patient included and patients were observed for pain for 24 hours
• oblique subcostal TAP block group
25 patient included and patients were observed for pain for 24 hours
• Local anesthetic infiltration group
25 patient included and patients were observed for pain for 24 hours
• control group
25 patient included and patients were observed for pain for 24 hours

Locations

Country	Name	City	State
Turkey	Ankara Bilkent City Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale Score	To find out which method provides more effective analgesia according to the visual analogue scale scores of patients followed for 24 hours	24 hours