Postoperative Pain Management in Laparoscopic Cholecystectomies

Postoperative Pain 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: Active, not recruiting

Administrative data

• NCT number: NCT06326281
• Other study ID #: ACHBILKENT-ANEST-BK-01
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: October 20, 2024

Study information

• Verified date: June 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, 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 20, 2024
• Est. primary completion date: September 20, 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 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Regional Anesthesia

Intervention

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
• unilateral oblique subcostal transversus abdominis plane block group
USG guided oblique subcostal transversus abdominis plane block block will perform unilateral with Bupivacaine. 25 patient included and patients were observed for pain for 24 hours
• 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

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

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	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
Primary	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	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
Secondary	postoperative shoulder pain	The patient with shoulder pain will be recorded; postoperative shoulder pain; will be evaluated as present or absent	24 hours