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Opioid-Sparing Multimodal Analgesia Versus Opioid Analgesia for Postoperative Pain After Elective Craniotomy

Primary Purpose

Analgesia Post Craniotomy

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Morphine versus multimodal analgesia for post elective craniotomy pain
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia Post Craniotomy

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Zagazig university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

opioid

multimodal

Arm Description

2.5mg/iv morphine every 6hr postoperative

combination of Gabapentin Orally (600 mg) the night before surgery and 2 hours before anesthesia induction plus dexmedetomidineIV bolus 1 μg/kg/10min + infusion pump 0.5 μg /kg/hrs intraoperative. Bupivacaine(scalp block) R/A 20ml 0.5% Postoperative. Acetaminophen IV 10-15 mg/kg 8hr postoperative. NSAIDs(ketorolac IV15-30mg every 6 postoperative

Outcomes

Primary Outcome Measures

pain score by VAS
To compare the effectiveness of opioid- sparing and opioid analgesia in the treatment of post-craniotomy pain

Secondary Outcome Measures

post medications complications
To compare adverse effects between opioid and opioid- sparing analgesia groups such as postoperative nausea and vomiting and excessive sedation.

Full Information

First Posted
July 22, 2022
Last Updated
April 28, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05474040
Brief Title
Opioid-Sparing Multimodal Analgesia Versus Opioid Analgesia for Postoperative Pain After Elective Craniotomy
Official Title
Opioid-Sparing Multimodal Analgesia Versus Opioid Analgesia for Postoperative Pain After Elective Craniotomy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 15, 2022 (Actual)
Study Completion Date
January 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Several neurosurgical procedures can cause postoperative pain including craniotomies for tumor resections, epilepsy surgery and craniotomies for aneurysm clipping, penetrating traumatic brain injury, and neuroradiological procedures such as arteriovenous embolization procedures and aneurysm coiling's. Postoperative hematomas, elevation of intracranial pressures, cerebral infarctions, seizures, hypertension, development of air embolism, cranial nerve injury, and the development of cerebral edema and stroke can complicate the management of postoperative pain . Within the initial 24 hours post craniotomy, 60% of patients experienced moderate-to-severe pain. Most patients describe the pain as predominantly superficial suggesting a pathogenesis that is somatic instead of visceral. It is believed to originate from soft tissue and per cranial muscle, rather than the brain tissue itself . Majority of patients undergoing craniotomy experienced severe pain in surgical site after the procedure.Insufficient pain control after craniotomy can increase the intracranial pressure in patients with compromised cerebral auto regulation, and arterial or intracranial hypertension can lead to intracranial hemorrhage . Moreover, most neurosurgeons want to ascertain the neurological results as early as possible, so cautious postoperative pain management is required so as not to disturb the neurological assessment after craniotomy . As a consequence of these conflicting scenarios and emerging interest in avoiding opioids, there is greater emphasis on sparing -opioid alternatives, as well as growing interest in the use of opioid-free anesthesia and perioperative analgesia . If the need for opiates is eliminated for these patient it will improve post-operative neurological examination significantly and hopefully decrease the number of investigations (e.g. computed tomography [CT] scans) due to more reliable clinical examination . There is lack of consensus and evidence regarding the use of common systemic analgesics for post craniotomy pain. Analgesic adjuvants like Paracetamol, NSAIDs, gabapentin, dexmedetomedine, scalp block can be used alone or in combination. When various analgesic drugs of different classes, different mechanisms of action, and adverse-effect profiles are used in combination, this may result in synergism of the analgesic effects. This method is called Multimodal analgesia, it is considered very effective and optimum for management of post craniotomy pain, in addition to opioid sparing effect . Rationale Stress response to pain after craniotomy procedure in the form of hemodynamic changes (hypertension and tachycardia) and increase in intracranial tension, can cause serious intracranial complications.Opioids are the most commonly used agents for treating moderate to severe postoperative pain, however it usually associated with adverse effects such as postoperative nausea and vomiting, respiratory depression and excessive sedation.Previous studies showed that combined use of multimodal opioid sparing analgesics such as Paracetamol, NSAIDs, Gabapentin, Dexamdetomedine, scalp block offers the promise of improved pain and reduced opioid consumption while preserving the clinical neurologic examination. Research question: Is multimodal opioid sparing analgesia safer, beneficial and more effective than opioids for post craniotomy analgesia? Aim of the study Adequate analgesia with less opioid consumption and related side effects in patients with elective craniotomy. Objectives To compare the effectiveness of opioid- sparing and opioid analgesia in the treatment of post-craniotomy pain: regarding pain relief time to the first rescue analgesia and total dose of postoperative analgesia. To compare adverse effects between opioid and opioid- sparing analgesia groups such as postoperative nausea and vomiting and excessive sedation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia Post Craniotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
opioid
Arm Type
Active Comparator
Arm Description
2.5mg/iv morphine every 6hr postoperative
Arm Title
multimodal
Arm Type
Active Comparator
Arm Description
combination of Gabapentin Orally (600 mg) the night before surgery and 2 hours before anesthesia induction plus dexmedetomidineIV bolus 1 μg/kg/10min + infusion pump 0.5 μg /kg/hrs intraoperative. Bupivacaine(scalp block) R/A 20ml 0.5% Postoperative. Acetaminophen IV 10-15 mg/kg 8hr postoperative. NSAIDs(ketorolac IV15-30mg every 6 postoperative
Intervention Type
Drug
Intervention Name(s)
Morphine versus multimodal analgesia for post elective craniotomy pain
Intervention Description
To compare the effectiveness of opioid- sparing multimodal analgesia and opioid analgesia in the treatment of post-craniotomy pain
Primary Outcome Measure Information:
Title
pain score by VAS
Description
To compare the effectiveness of opioid- sparing and opioid analgesia in the treatment of post-craniotomy pain
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
post medications complications
Description
To compare adverse effects between opioid and opioid- sparing analgesia groups such as postoperative nausea and vomiting and excessive sedation.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Essamedin Negm, MD
Organizational Affiliation
Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig university
City
Zagazig
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Opioid-Sparing Multimodal Analgesia Versus Opioid Analgesia for Postoperative Pain After Elective Craniotomy

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