Postoperative Pain Management in Laparoscopic Cholecystectomies

NCT06326281 | Active Not Recruiting

• 1 other identifier: ACHBILKENT-ANEST-BK-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Regional Anesthesia

Keywords

regional anesthesia; laparoscopic cholecystectomy; external oblique intercostal plane block; postoperative pain; analgesia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• postoperative nause and vomiting

  24 hours

• postoperative shoulder pain

  24 hours

Study Arms (4)

External oblique intercostal plane block group

ACTIVE COMPARATOR

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

Oblique subcostal transversus abdomınıs plane block group

ACTIVE COMPARATOR

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

Local anesthetic infiltration group

ACTIVE COMPARATOR

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

Control Group

SHAM COMPARATOR

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

Interventions

unilateral external oblique intercostal plane block group 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

External oblique intercostal plane block group

unilateral oblique subcostal transversus abdomınıs plane block group 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

Oblique subcostal transversus abdomınıs plane block group

Local anesthetic infiltration group PROCEDURE

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

Local anesthetic infiltration group

Control group 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

Also known as: intravenous patient controlled analgesia group with tramadol

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bılkent City Hospital

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Control Groups; Tramadol

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids

Study Officials

• Buğra Kurtoğlu, MD

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients were not told which method would be used The person evaluating the patients did not know which method was applied to which patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant doctor

Model Details: Evaluation of postoperative pain in 4 groups in laparoscopic cholecystectomy with control group

Study Record Dates

• First Submitted: March 17, 2024
• First Posted: March 22, 2024
• Study Start: March 20, 2024
• Primary Completion: September 20, 2024
• Study Completion: October 20, 2024
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)