Pain, PostoperativeNCT05117034
Pre-emptive Intravenous Morphine for Acute Post-craniotomy Pain.
A study testing Morphine and Nacl 0.9% in people with Pain, Postoperative and Anesthesia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
We propose a double-blind randomized controlled trial to evaluate the effect of intravenously administered morphine at surgery conclusion on acute postoperative pain in patients recovering from craniotomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Postoperative, Anesthesia, Analgesia
- What is being tested?
- Morphine and Nacl 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Feb 2022to 1 May 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent.
- Scheduled for elective craniotomy for resection of supra-tentorial intracranial tumor that requires cranium sawing, dural opening and excision of tumor, under general anesthesia.
- Age 18 - 80 years.
- American Society of Anesthesiologists' physical status I-III.
- Body mass index (BMI) under 35 kg/m2.
Who cannot join
- Pregnant or current breastfeeding patients.
- Patients unable to provide informed consent or in need of a legal authorized representative.
- Patients with neurological disorders preventing a good understanding of the pain numerical reporting scale (NRS) before surgery.
- Patients with pre-operative aphasia.
- Patients with chronic pain or chronic use of opioids.
- Patients with current alcohol or drug abuse.
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- Expected delayed extubation.
- Patients with documented allergy to opioids or acetaminophen.
- Preoperative Glasgow Coma Scale <15.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Tel-Aviv Medical Center, Sackler faculty of medicine, Tel-Aviv University, Israel
Tel Aviv
About this study
Official title: Pre-emptive Intravenous Morphine for Acute Post-craniotomy Pain: a Randomized, Double-blind, Placebo-controlled Trial.
We propose a double-blind randomized controlled trial to evaluate the effect of intravenously administered morphine at surgery conclusion on acute postoperative pain in patients recovering from craniotomy surgery. Participating adults having craniotomy surgery will be randomized in a 1:1 ratio to intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure, or a matching placebo.
Read the detailed description
After confirming eligibility, patients will be approached by one of the study researchers for potential participation. After a thorough explanation, written informed consent will be obtained.
General anesthesia will be induced with propofol (2-3 mg/kg), and either remifentanil (1 mcg/kg) or fentanyl (2 mcg/kg). Lidocaine (1 mg/kg) and rocuronium (0.6 mg/kg) will be allowed and left to the discretion of the caregivers. Anesthesia will be maintained with infusions of propofol and remifentanil, and titrated to maintain hemodynamic goals and evaluation of anesthesia depth by somatosensory or motor evoked potentials according to clinical requirements. Ketamine and fentanyl administration will not be allowed at the maintenance phase. No additional IV opioids will be allowed during surgery. Other analgesics such as dipyrone and non-steroidal anti-inflammatory agents (such as diclofenac) will not be allowed during surgery or during PACU stay. At dura closure, patients will be randomized by a web-based randomization service in a 1:1 ratio. The intervention group will receive 0.08 mg/kg intravenous morphine (0.08 ml/kg), while the control group will receive 0.08 ml/kg 0.9% NaCl. The research solution (morphine/0.9% NaCl) will be administered via IV infusion over ten minutes. Randomization and study drug preparation will be performed by a research team-member, uninvolved in data collection, analysis, or patient care.
Both groups will receive acetaminophen (1 gr) at dura closure. Steroids and other anti-emetic medications will be allowed. Remifentanyl and propofol infusions will be discontinued at the end of the surgery during wound dressing. All patients will have orders for intravenous morphine administration in PACU for breakthrough pain as acceptable and according to the orders prescribed by anesthesiologist assigned for the case/the attending anesthesiologist in PACU. The research team/protocol does not interfere with morphine administration during PACU stay. All caregivers will be blinded to treatment allocation.
Patient's monitoring at the operating room and during transportation to the PACU will be done by the anesthesiologist assigned for the case. Patient's monitoring during PACU stay will be done by the PACU team and according to the patient's clinical status according to PACU protocol. Patients will be followed during PACU stay by a study team member blinded to the treatment allocation. The study team member will measure and record pain score (NRS), sedation score (Ramsay score) and PONV at admission to PACU and 30 minutes after admission to PACU. The research team, according the research hypothesis is interested in measuring pain (via NRS) while the patient is fully conscious and alert. Additional data regarding the surgery, anesthesia, recovering from anesthesia and PACU stay will be collected retroactively from computer system data (metavision, chameleon).
Demographic and clinical data will be collected on the day of surgery. Surgical and anesthetic data, laboratory results, details regarding side effects, time of first morphine requirement, total morphine consumption in PACU, and pain scores (NRS) at POD1 and POD2 will be collected from computerized patient files.
- Conditions
- Pain, Postoperative, Anesthesia, Analgesia
- Being tested
- Morphine, Nacl 0.9%
- Keywords
- Craniotomy, Post-craniotomy pain, Opioid analgesia
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MorphineDrug
Intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure.
Nacl 0.9%Drug
Intraoperative intravenous administration of 0.08 ml/kg NaCl 0.9% at dura closure.
| Study group | Role | What they receive |
|---|---|---|
| Morphine | Experimental | Intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure. Receives: Drug: Morphine |
| Placebo | Placebo comparator | Intraoperative intravenous administration of 0.08 ml/kg NaCl 0.9% at dura closure. Receives: Drug: Nacl 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
First NRS pain score.
The numeric rating scale (NRS), a validated tool used to assess patients' self-reported pain level, will be taken at admission to the post anesthesia care unit (PACU). NRS score ranges from 0 to 10, with higher scores representing worse pain.
Measured: Up to 1 hour from PACU admission
Secondary outcomes (2)
Time to first rescue morphine administration
Time measured (in minutes) from admission to the post anesthesia care unit (PACU) to patient's first rescue morphine administration.
Measured: During 2 hours from PACU admission.
Total morphine consumption
Total dosage of rescue morphine given to the patient during the first two hours of PACU stay.
Measured: During 2 hours from PACU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2021
- Study start16 Feb 2022
- Primary completion1 May 2025 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Model description
- A double-blind randomized controlled trial. Participating adults having craniotomy surgery will be randomized in a 1:1 ratio to intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure, or a matching placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Barak Cohen, MD, Tel-Aviv Sourasky Medical Center
- Investigators
- Or Goren, MD, Principal investigator, Department of Anesthesia, Intensive Care, and Pain Management, Tel-Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05117034
- Sponsor's protocol ID
- 0193-21-TLV-OG
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2021
- Last updated
- 20 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-emptive Intravenous Morphine for Acute Post-craniotomy Pain: a Randomized, Double-blind, Placebo-controlled Trial.
- ClinicalTrials.gov ID
- NCT05117034
- Acronym / sponsor ID
- 0193-21-TLV-OG
- Conditions
- Pain, Postoperative, Anesthesia, Analgesia
- Keywords
- Craniotomy, Post-craniotomy pain, Opioid analgesia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 11 Nov 2021 (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.
We propose a double-blind randomized controlled trial to evaluate the effect of intravenously administered morphine at surgery conclusion on acute postoperative pain in patients recovering from craniotomy surgery. Participating adults having craniotomy surgery will be randomized in a 1:1 ratio to intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure, or a matching placebo.
Detailed description
After confirming eligibility, patients will be approached by one of the study researchers for potential participation. After a thorough explanation, written informed consent will be obtained.
General anesthesia will be induced with propofol (2-3 mg/kg), and either remifentanil (1 mcg/kg) or fentanyl (2 mcg/kg). Lidocaine (1 mg/kg) and rocuronium (0.6 mg/kg) will be allowed and left to the discretion of the caregivers. Anesthesia will be maintained with infusions of propofol and remifentanil, and titrated to maintain hemodynamic goals and evaluation of anesthesia depth by somatosensory or motor evoked potentials according to clinical requirements. Ketamine and fentanyl administration will not be allowed at the maintenance phase. No additional IV opioids will be allowed during surgery. Other analgesics such as dipyrone and non-steroidal anti-inflammatory agents (such as diclofenac) will not be allowed during surgery or during PACU stay. At dura closure, patients will be randomized by a web-based randomization service in a 1:1 ratio. The intervention group will receive 0.08 mg/kg intravenous morphine (0.08 ml/kg), while the control group will receive 0.08 ml/kg 0.9% NaCl. The research solution (morphine/0.9% NaCl) will be administered via IV infusion over ten minutes. Randomization and study drug preparation will be performed by a research team-member, uninvolved in data collection, analysis, or patient care.
Both groups will receive acetaminophen (1 gr) at dura closure. Steroids and other anti-emetic medications will be allowed. Remifentanyl and propofol infusions will be discontinued at the end of the surgery during wound dressing. All patients will have orders for intravenous morphine administration in PACU for breakthrough pain as acceptable and according to the orders prescribed by anesthesiologist assigned for the case/the attending anesthesiologist in PACU. The research team/protocol does not interfere with morphine administration during PACU stay. All caregivers will be blinded to treatment allocation.
Patient's monitoring at the operating room and during transportation to the PACU will be done by the anesthesiologist assigned for the case. Patient's monitoring during PACU stay will be done by the PACU team and according to the patient's clinical status according to PACU protocol. Patients will be followed during PACU stay by a study team member blinded to the treatment allocation. The study team member will measure and record pain score (NRS), sedation score (Ramsay score) and PONV at admission to PACU and 30 minutes after admission to PACU. The research team, according the research hypothesis is interested in measuring pain (via NRS) while the patient is fully conscious and alert. Additional data regarding the surgery, anesthesia, recovering from anesthesia and PACU stay will be collected retroactively from computer system data (metavision, chameleon).
Demographic and clinical data will be collected on the day of surgery. Surgical and anesthetic data, laboratory results, details regarding side effects, time of first morphine requirement, total morphine consumption in PACU, and pain scores (NRS) at POD1 and POD2 will be collected from computerized patient files.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A double-blind randomized controlled trial. Participating adults having craniotomy surgery will be randomized in a 1:1 ratio to intraoperative intravenous administration of 0.08 mg/kg morphine at dura closure, or a matching placebo.
| Arm | Type | Receives |
|---|---|---|
| Morphine | Experimental | Drug: MorphineIntraoperative intravenous administration of 0.08 mg/kg morphine at dura closure. |
| Placebo | Placebo comparator | Drug: Nacl 0.9%Intraoperative intravenous administration of 0.08 ml/kg NaCl 0.9% at dura closure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed consent.
- Scheduled for elective craniotomy for resection of supra-tentorial intracranial tumor that requires cranium sawing, dural opening and excision of tumor, under general anesthesia.
- Age 18 - 80 years.
- American Society of Anesthesiologists' physical status I-III.
- Body mass index (BMI) under 35 kg/m2.
Key exclusion criteria (9 listed)
- Pregnant or current breastfeeding patients.
- Patients unable to provide informed consent or in need of a legal authorized representative.
- Patients with neurological disorders preventing a good understanding of the pain numerical reporting scale (NRS) before surgery.
- Patients with pre-operative aphasia.
- Patients with chronic pain or chronic use of opioids.
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 |
|---|---|---|
| MorphineIntraoperative intravenous administration of 0.08 mg/kg morphine at dura closure. | Drug | Morphine |
| Nacl 0.9%Intraoperative intravenous administration of 0.08 ml/kg NaCl 0.9% at dura closure. | Drug | Placebo |
Primary outcome
First NRS pain score.
Time frame: Up to 1 hour from PACU admission
The numeric rating scale (NRS), a validated tool used to assess patients' self-reported pain level, will be taken at admission to the post anesthesia care unit (PACU). NRS score ranges from 0 to 10, with higher scores representing worse pain.
2 secondary outcomes
Time to first rescue morphine administration
Time frame: During 2 hours from PACU admission.
Total morphine consumption
Time frame: During 2 hours from PACU admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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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.
Or Goren, MD principal investigator
Department of Anesthesia, Intensive Care, and Pain Management, Tel-Aviv Medical Center
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 and Nacl 0.9% in people with Pain, Postoperative and Anesthesia, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 5 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2024. 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 Israel. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
First NRS pain score. (time frame: Up to 1 hour from PACU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2024.