Evaluation of Multimodal Analgesia With NOL

NCT06238830 | Unknown

• 1 other identifier: E2-23-4785
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study will include 80 patients undergoing Laparoscopic Cholecystectomy Surgery as part of elective requirements. The study is a single-center, prospective, randomized controlled trial The aim of the study is

1. 1.To investigate the effectiveness of multimodal analgesia, which includes the newly introduced external oblique intercostal plane block, with the assistance of NOL (Nociception Level), in the management of postoperative pain following commonly performed Laparoscopic Cholecystectomy surgeries.
2. 2.This approach is intended to objectively assess changes in postoperative recovery scores

Conditions

Pain, Postoperative; Analgesia

Keywords

multimodal analgesia; nociceptive level index; NOL; External Oblique Intercostal Plane Block; EIOB

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Multimodal Analgesia on the Nociceptive Level İndex(NOL)

  The NOL index is a single number between 0 and 100. A NOL between 0 and 25 represents a physiologically suppressed response adequately inhibiting harmful stimuli, indicating sufficient analgesia. A NOL index greater than 25 (continuous or fluctuating) for multiple minutes signifies the patient is perceiving pain. Higher values indicate a stronger nociceptive response. An index consistently below 10 for more than a minute may suggest excessive anti-nociception, prompting consideration for reducing analgesics. If regional analgesia is employed, lower NOL values are anticipated. The dosage of remifentanil will be increased if the patient's NOL value remains elevated for 2 minutes when it surpasses 25.The number of changes in Ultiva dosage, NOL values will be recorded before intubation, after intubation, during thoracic entry, and during inflation and deflation, as well as at the time of extubation.

  during surgery time

Secondary Outcomes (2)

• Change From Baseline in Postoperative Recovery Scores on the Visual Analog Scale at Postoperative 30 Minutes

  postoperative 30 minute

• The intensity of nausea and vomiting

  postoperative 30 minute

Study Arms (2)

GROUP M

In patients undergoing elective Laparoscopic Cholecystectomy Surgery, after routine anesthesia induction, a magnesium loading dose of 30 mg/kg will be administered intravenously. Subsequently, a magnesium infusion will be initiated at a rate of 10 mg/kg/hour. Afterward, in the supine position, necessary field preparation and ultrasound (USG) setup will be conducted to administer the External Oblique Intercostal Plane (EOIP) block.The procedure will be applied unilaterally. After desufflation, patients will receive 50 mg dexketoprofen as standard analgesia administered intravenously as a non-steroidal anti-inflammatory drug (NSAID).

GROUP K

As part of standard analgesia, 50 mg dexketoprofen, administered intravenously as a non-steroidal anti-inflammatory drug (NSAID), will be applied, and these patients will be considered as the control group. All patients will undergo general anesthesia induction with 1 µg/kg fentanyl, 2-3 mg/kg propofol, and 0.6 mg/kg rocuronium bromide. During anesthesia maintenance, a mixture of 50% O2 and air will be administered, and sevoflurane will be used at a minimum alveolar concentration of 0.8 (with a target MAC value of 0.8-1.2). Additionally, remifentanil will be administered at a rate of 0.01-0.2 mcg/kg/min. The remifentanil dose range will be increased if the patient\'s Nociceptive Level (NOL) value remains elevated for 2 minutes when it exceeds 25. BIS monitoring will be performed for all patients, and the BIS value will be maintained between 40-50.

Eligibility Criteria

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

Study Population

Patients scheduled for elective laparoscopic cholecystectomy.

You may qualify if:

• Individuals aged between 18 and 65 years old
• Those undergoing elective laparoscopic cholecystectomy
• Patients with ASA risk scores of I and II
• Body Mass Index (BMI) \< 35 kg/m2
• Patients who have provided informed consent before the procedure
• Individuals who are literate and capable of giving consent.

You may not qualify if:

• Patients under 18 years of age and those over 65 years of age
• Individuals with an ASA score of III or higher
• Cases with a surgical duration of less than 60 minutes
• Emergency surgeries
• Those with a history of abdominal surgery
• Pregnant or lactating patients
• Individuals with coagulopathy or using anticoagulant medications
• Those allergic to local anesthetics
• Individuals with localized infection at the injection site
• Patients without the ability to use Patient Controlled Analgesia (PCA) and assess Visual Analog Scale (VAS)
• Patients with peripheral nerve disease
• Individuals with kidney failure and congestive heart failure
• Patients undergoing elective Laparoscopic Cholecystectomy (LK) due to malignancy.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Related Links

• Kehlet, H., et al., A procedure-specific systematic review and consensus recommendations for postoperative analgesia following laparoscopic cholecystectomy. Surg Endosc, 2005. 19(10): p. 1396-415.
• Tulgar, S., O. Selvi, and M.S. Kapakli, Erector Spinae Plane Block for Different Laparoscopic Abdominal Surgeries: Case Series. Case Rep Anesthesiol, 2018. 2018: p. 3947281.

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

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

Study Officials

• AYÇA TUBA DUMANLI ÖZCAN

  ANKARA BİLKENT CİTY HOSPİTAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

AYÇA TUBA DUMANLI ÖZCAN

CONTACT

+905057154125; draycaozcan@gmail.com

sena sarıcaoğlu öktem

CONTACT

+905386002190; senasaricaoglu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: February 2, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2024-01