Effects of SCALP Block on Postoperative Analgesia in Craniotomy Surgery

Not Applicable

Completed

• Conditions: Analgesia

• Registration Number: NCT06588751
• Lead Sponsor: Konya City Hospital

Brief Summary

Patients undergoing craniotomy surgery often experience severe postoperative pain. This pain can affect the patient's hemodynamics, disrupt sleep patterns, and prolong hospital stays. Sudden increases in heart rate and blood pressure due to pain may lead to elevated intracranial pressure in patients, potentially causing morbidity and mortality. Opioids are commonly used to mitigate hemodynamic fluctuations and reduce postoperative pain; however, they may delay recovery, contribute to excessive sedation, and affect postoperative neurological examinations. Additionally, opioids have adverse effects such as nausea, vomiting, and respiratory depression. Alleviating hemodynamic instability and postoperative pain are critical concerns for neuro anesthesiologists. Regional analgesia techniques are employed in neurosurgery patients because they minimize anesthesia requirements, alleviate pain, and allow for neurological assessment with a lower incidence of systemic complications.The scalp block was developed due to its potential benefits as an effective regional anesthesia technique that supports the advancement of delicate brain surgeries such as functional and microsurgeries.

Detailed Description

In this study, we hypothesize that patients who receive a SCALP block will have lower postoperative Numerical Rating Scale scores and consume less total analgesia.

Our primary objective is to evaluate postoperative numerical rating scale scores in patients undergoing craniotomy surgery with a SCALP block.

Our secondary objectives are to assess the total amount of rescue analgesia consumed, the time to first rescue analgesia, patient satisfaction, and any possible complications. The study was planned as a prospective, randomized, controlled, double blind. At each clinic, an anesthesiologist randomly allocated patients to two significant groups using numbered opaque sealed envelopes: Group S (patients receiving SCALP block) and Group C (patients getting just multimodal analgesia). The anesthesiologists responsible for the randomization process were not involved in any other sections of the trial, and the individuals executing the SCALP blocks procedure were not engaged in other areas of the research. Additionally, the researcher who intervened, the participants, and the analyzer were blinded to the details of the study. After the surgery, two different anesthesia technicians recorded the primary and secondary results of the study.

Study Timeline

• Study First Submitted: 2024-09-07
• Study First Submitted QC: 2024-09-07
• Study First Posted: 2024-09-19
• Study Start: 2024-10-07
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-10
• Primary Completion: 2024-11-11
• Study Completion: 2024-11-11
• Last Update Posted: 2024-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 18-65 years
• General anesthesia
• American Society of Anesthesiologists physical status I-III

Exclusion Criteria

• Contraindications to regional anesthesia
• Coagulation disorders
• Known allergy to local anesthetics
• Infections at the block site
• Pregnant patients
• Emergency cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Scalp	One day	Our primary objective is to evaluate postoperative numerical rating scale scores in patients undergoing craniotomy surgery with a SCALP block. (Numerical rating scale score 0-10 point. 0= Very Bad, 10= Very Good

Trial Locations

Locations (1)

Konya City Hospital; 🇹🇷 Konya, Turkey