Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 11:00 PM
Study NCT ID:
NCT05117034
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-20
First Post:
2021-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pre-emptive Intravenous Morphine for Acute Post-craniotomy Pain.
Sponsor:
Tel-Aviv Sourasky Medical Center
Organization:
Study Overview
Official Title:
Pre-emptive Intravenous Morphine for Acute Post-craniotomy Pain: a Randomized, Double-blind, Placebo-controlled Trial.
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: