Clinical trial NCT06326281: Postoperative Pain Management in Laparoscopic Cholecystectomies
Official title: Comparison of External Oblique Intercostal Plane Block Oblique Subcostal Transversus Abdominis Plane Block and Local Anesthetic Infiltration Methods in Laparoscopic Cholecystectomies
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Postoperative Pain
Regional Anesthesia
Keywords: regional anesthesia
laparoscopic cholecystectomy
external oblique intercostal plane block
postoperative pain
analgesia
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Amount of postoperative opioid use
timeFrame: 24 hours
measure: Finding out which method is more effective according to the Numerical Rating Scale (0-10)
timeFrame: 24 hours
Secondary outcomes:
measure: postoperative nause and vomiting
timeFrame: 24 hours
measure: postoperative shoulder pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bılkent City Hospital
Study officials:
affiliation: Ankara City Hospital Bilkent
name: Buğra Kurtoğlu, MD
role: PRINCIPAL_INVESTIGATOR
References: