Analgesia Post CraniotomyNCT05474040
Opioid-Sparing Multimodal Analgesia Versus Opioid Analgesia for Postoperative Pain After Elective Craniotomy
A study testing Morphine versus multimodal analgesia for post elective craniotomy pain in people with Analgesia Post Craniotomy, run by Zagazig University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Analgesia Post Craniotomy
- What is being tested?
- Morphine versus multimodal analgesia for post elective craniotomy pain
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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 .
Read more
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.
- Conditions
- Analgesia Post Craniotomy
- Being tested
- Morphine versus multimodal analgesia for post elective craniotomy pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine versus multimodal analgesia for post elective craniotomy painDrug
To compare the effectiveness of opioid- sparing multimodal analgesia and opioid analgesia in the treatment of post-craniotomy pain
| Study group | Role | What they receive |
|---|---|---|
| opioid | Active comparator | 2.5mg/iv morphine every 6hr postoperative Receives: Drug: Morphine versus multimodal analgesia for post elective craniotomy pain |
| multimodal | Active comparator | 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 Receives: Drug: Morphine versus multimodal analgesia for post elective craniotomy pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain score by VAS
To compare the effectiveness of opioid- sparing and opioid analgesia in the treatment of post-craniotomy pain
Measured: 24 hours
Secondary outcomes (1)
post medications complications
To compare adverse effects between opioid and opioid- sparing analgesia groups such as postoperative nausea and vomiting and excessive sedation.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start15 Dec 2021
- Primary completion15 Dec 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia Post CraniotomyStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Essamedin Mamdouh Negm, Zagazig University
- Investigators
- Essamedin Negm, MD, Principal investigator, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474040
- Sponsor's protocol ID
- 8099-12-10-2021
- Status last verified
- Apr 2023
- First submitted
- 22 Jul 2022
- Last updated
- 1 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Negm EM, Younus MA, Morsy AA, El Gammal SMS, El-Harrisi MA, Sameaa FAA, Rashad RAM, Elserafy TS, Gouda AM. Opioid-sparing multimodal analgesia for post-craniotomy pain: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2025 Aug 29;25(1):437. doi: 10.1186/s12871-025-03306-5.
PubMed 40883667
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opioid-Sparing Multimodal Analgesia Versus Opioid Analgesia for Postoperative Pain After Elective Craniotomy
- ClinicalTrials.gov ID
- NCT05474040
- Acronym / sponsor ID
- 8099-12-10-2021
- Conditions
- Analgesia Post Craniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| opioid | Active comparator | Drug: Morphine versus multimodal analgesia for post elective craniotomy pain2.5mg/iv morphine every 6hr postoperative |
| multimodal | Active comparator | Drug: Morphine versus multimodal analgesia for post elective craniotomy paincombination 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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Morphine versus multimodal analgesia for post elective craniotomy painTo compare the effectiveness of opioid- sparing multimodal analgesia and opioid analgesia in the treatment of post-craniotomy pain | Drug | multimodal, opioid |
Primary outcome
pain score by VAS
Time frame: 24 hours
To compare the effectiveness of opioid- sparing and opioid analgesia in the treatment of post-craniotomy pain
1 secondary outcome
post medications complications
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Derived from this study: PubMed 40883667Negm EM, Younus MA, Morsy AA, El Gammal SMS, El-Harrisi MA, Sameaa FAA, Rashad RAM, Elserafy TS, Gouda AM. Opioid-sparing multimodal analgesia for post-craniotomy pain: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2025 Aug 29;25(1):437. doi: 10.1186/s12871-025-03306-5.
- Individual participant dataSharing planned: Undecided
Related trials for Analgesia Post Craniotomy
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Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery
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Efficacy of Liposomal Bupivacaine Scalp Nerve Block for Postoperative Pain Management After Supratentorial Craniotomy
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Pre-emptive Scalp Infiltration With Low-dose Flurbiprofen and Ropivacaine for Postoperative Analgesia After Craniotomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Essamedin Negm, MD principal investigator
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine versus multimodal analgesia for post elective craniotomy pain in people with Analgesia Post Craniotomy, run by Zagazig University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain score by VAS (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474040, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.