Multimodal Opioid-Sparing Analgesia for Post-Craniotomy Pain Management
Morphine versus multimodal analgesia for post elective craniotomy pain
Treatment Study
Summary
Study start date: December 15, 2021
Actual date on which the first participant was enrolled.This study focuses on managing pain after a type of brain surgery called a craniotomy. The goal is to find a way to effectively reduce pain while using fewer opioids, which are strong painkillers that can have side effects like nausea, vomiting, and excessive sleepiness. The study involves people who have had elective craniotomies, which are planned surgeries to treat conditions like tumors or aneurysms. The importance of this research lies in the potential to improve recovery after brain surgery, reduce the need for opioids, and lower the risk of complications associated with their use. Participants in this study will receive either standard opioid painkillers or a combination of different types of pain-relieving medications known as 'multimodal analgesia'. This combination may include drugs like Paracetamol, NSAIDs, Gabapentin, and Dexmedetomidine, as well as a scalp block, which is a local anesthetic injected into the scalp. The study will compare the effectiveness of these two approaches in relieving pain, looking at factors such as the time until the first request for additional pain relief and the total amount of pain medication used. It will also monitor for any side effects, including nausea, vomiting, and excessive sleepiness.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 21 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Inclusion Criteria: \- 1. Patient consent. 2. Age : (21 to 65) years. 3. Sex : both. 4. ASA grade I-II (American society of anesthiologists). 5. Prepared to elective craniotomy under general anesthesia (for eg draining of Abscess, tumor, blood clot or aneurysm). 6\. Ability to take pills Exclusion Criteria: * 1\. Disturbed conscious level (Glascow coma score less than14). 2. Previous craniotomy. 3. Chronic use of analgesics or drug dependence or regular anticonvulsant, neuropathic or antidepressant use. 4\. Uncontrolled hypertension. 5. Extensive surgeries lasting more than 6 hours or patient needing postoperative ventilator support. 6\. Intracranial malformations. 7. Any complications during procedure such as massive intracranial hemorrhage. 8. Psychological disorder requiring pharmacologic treatment. 9. Regular systemic steroid use. 10. Renal impairment or liver dysfunction. 11. Allergy 12. Bleeding tendency
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location