Postoperative Pain Management in Laparoscopic Cholecystectomies

NCT ID: NCT06326281

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2024-10-20

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.

Conditions

Postoperative Pain; Regional Anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

unilateral external oblique intercostal plane block group

Intervention Type: PROCEDURE

USG guided external oblique intercostal plane block will perform unilateral with Bupivacaine 25 patient included and patients were observed for pain for 24 hours

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

Group Type: ACTIVE_COMPARATOR

unilateral oblique subcostal transversus abdomınıs plane block group

Intervention Type: PROCEDURE

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

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

Group Type: ACTIVE_COMPARATOR

Local anesthetic infiltration group

Intervention Type: PROCEDURE

Bupivacaine infiltration will be performed to trocar insertion sites. 25 patient included and patients were observed for pain for 24 hours

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

Group Type: SHAM_COMPARATOR

Control group

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: 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

Intervention Type: PROCEDURE

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

Intervention Type: DRUG

Other Intervention Names

intravenous patient controlled analgesia group with tramadol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ankara City Hospital Bilkent

OTHER

Sponsor Role: lead

Responsible Party

Selahattin Buğra Kurtoğlu

Assistant doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Buğra Kurtoğlu, MD

Role: PRINCIPAL_INVESTIGATOR

Ankara City Hospital Bilkent

Locations

Ankara Bılkent City Hospital

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

ACHBILKENT-ANEST-BK-01

Identifier Type: -

Identifier Source: org_study_id