Comparison of the Analgesic Effects of Scalp Nerve Block and Intravenous Ibuprofen Applications Under the Guidance of Nociception Level Index (NoL) in Patients Undergoing Elective Supratentorial Craniotomy

• Status: Recruiting
• Trial end date: 2023-03-05
• Target enrollment: 0
• Participant gender: All

Summary

Introduction: Scalp incision is a powerful nociceptive stimulus that can exacerbate rapid changes in hemodynamic and sympathetic activity. Management of hemodynamic stability is essential in neuro-anesthesia and can be challenging among neurosurgery anesthesiologists. Neurosurgery operations include steps with a lot of painful stimuli such as intubation, insertion of a head-pinning, and craniotomy. A good anesthetic technique can improve hemodynamic responses by reducing the incidence of complications such as intracranial hypertension, bleeding, and longer recovery time. Routine analgesic approach in the intraoperative and postoperative period of supratentorial craniotomy includes the routine use of paracetamol, opioids, scalp nerve block with proven effectiveness, and intravenous ibuprofen, which gives good results by reducing opioid doses in moderate-to-severe pain. Supratentorial craniotomy surgery, which requires tight hemodynamic control, needs effective analgesic methods.

Trial design: It is a prospective, randomized controlled, consisting of factorial groups, double-blind study.

Participants: This study will be carried out at Ankara University Faculty of Medicine İbni Sina Hospital (Altındağ, Ankara, Turkey) between November 2022 and February 2023. One hundred and two ASA I-III patients with a body mass index (BMI) below 30, aged between 18 and 65, who will undergo elective supratentorial craniotomy due to a brain tumor, are planned to be included in the study.

Interventions: The group in which IV ipurofen was administered was named Ibuprofen Group (Group I), the group in which scalp nerve block was applied Block Group (Group), and the group in which IV ibuprofen and scalp nerve block were applied together was named Ibuprofen+Block Group (IB Group). In the premedication unit, 800 mg of ibuprofen in 100 ml of normal saline will be administered to Group I and Group IB, and 100 ml of normal saline without ibuprofen will be administered to Group B as a 30-minute IV infusion. After intubation, a scalp nerve block with 20 ml of 0.5% bupivacaine will be applied to Group B and Group IB, and 20 ml of normal saline will be injected into the block sites in Group I.

Objective: The investigators aimed to show the effect of scalp nerve block and IV ibuprofen applications, which are routinely applied, on the optimization of the patient's process from induction to the early postoperative period. In addition, the investigators will examine the comparison of hemodynamic and analgesic effects of scalp nerve block and IV ibuprofen applications under the guidance of pain monitor, and their contribution to reducing opioid consumption, which has side effects such as postoperative nausea/vomiting, slowing of GI motility, respiratory depression.

Outcome: The primary endpoint of the study was the differences between the groups in the changes in the patients' nociception level (NoL) index, heart rate, and blood pressure parameters at the time of head-pinning and the first surgical skin incision.

Randomization: Randomization of the patients into 3 groups will be carried out using the closed envelope method.

Blinding: The patients included in the study and the practicing anesthesiologist do not know which patient is included in which group.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ankara University
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• Undergoing elective suptatentorial craniotomy surgery

• Body Mass Index (BMI) below 30

• ASA I-III patient

Exclusion Criteria:

• Patients with a history of allergic reaction to the drugs to be used in the study

• Patients with heart, kidney and liver failure

• Patients who refused to participate in the study