Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06483659
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-06-23
Brief Title:
Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Intravenous Oxytocin for Post Operative Pain After Minimally Invasive Hysterectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This is a randomized double-blinded placebo-controlled trial to compare the effectiveness of IV oxytocin infusion to placebo on peri-operative opioid consumption and reducing post-operative pain following a minimally invasive hysterectomy under general anesthesia
Detailed Description:
152 women will be randomized into one of two arms participants in the first arm Intervention will receive oxytocin infusion 30 IU in 500 ml IV infusion at a rate of 5 IUh 8333 mlh the second arm Control will receive 09 normal saline 500 ml IV infusion at the same rate of 833 mlh The primary care team anesthesia surgery and nursing the research team and the patient will all be blinded to the research arm
The investigational research pharmacy will perform randomization participants will be randomized in a 11 ratio to receive either Oxytocin or Placebo 09 normal saline Randomization will be blinded to investigators to prevent bias and ensure balance in treatment arms throughout the study Participants surgeons clinicians and raters will be blinded with respect to treatment assignments The investigational pharmacy will prepare the study drug based on the randomization assignment received
The investigators will identify patients who have been scheduled for an elective minimally invasive hysterectomy at Brigham and Womens Hospital by reviewing the operating room booking schedule
Patients will be pre-screened for inclusion and exclusion criteria Subsequently they will be recruited for participation in this study by phone MGB Zoom and will be consented by electronic consent
Once the patient is recruited and consented they will be randomized for either the intervention group oxytocin IV infusion or the control group 09 normal saline IV infusion
An email will be sent to those who consent with a link to the secure REDCap system containing a set of baseline questionnaires to assess relevant medical and surgical history pre-operative pain analgesic medication use and psychosocial variables
Both groups intervention and control will be treated pre-operatively with the following Early Recovery After Surgery ERAS medications as per usual institutional practice
acetaminophen 1000 mg orally
celecoxib 400 mg orally The Investigational Research Pharmacy will be informed and prepare blinded infusions for perioperative administration oxytocin or placebo
The primary anesthesiology team will receive either the study medication or placebo in a 500 ml bag labeled as Oxytocin Study Drug for IV infusion
A recommended Intra-Operative Analgesia Management algorithm will be given to the primary anesthetic team The recommended algorithm for intra-operative analgesia management will include the following
Fentanyl 100 mcg IV for induction
Dexamethasone 8 mg IV after induction but prior to skin incision
Small titrated doses of Hydromorphone IV boluses 02-04 mg during the operation and before emergence according to primary team judgment
Ketorolac 30 mg IV prior to skin closure unless otherwise contraindicated
Avoidance of other multimodal analgesic agents not included in this protocol to limit confounders
The infusion will be started after the skin incision and will continue until the infusion is completed or the post-anesthesia care unit PACU criteria are met whichever occurs first
Other aspects of each patients routine clinical care will continue as per standard care at the attending physicians discretion under whom the patient is admitted regardless of treatment arm status
In the PACU a brief postoperative pain questionnaire will be performed including the Surgical Pain Scales SPS
The SPS is a validated scale consisting of 4 items that measure pain at rest during normal activities and during workexercise and quantify the unpleasantness of worst pain This scale has been validated in a number of different types of postoperative pain including women after gynecologic surgery
Vital signs numeric rating scale NRS pain scores and opioid consumption in PACU will be collected from the patients medical record
Patients whose surgery was converted to open estimated blood loss EBL 500 ml or any other surgical complication that necessitates hospitalization will be excluded from the trial
For secondary outcomes including total opioid consumption in 24 48 and 72 hours and pain scores at postoperative day POD1 2 and 3 an online survey will be done at POD1 2 and 3 and follow-up will continue until 3 months post-op
The investigational research pharmacy will perform randomization participants will be randomized in a 11 ratio to receive either Oxytocin or Placebo 09 normal saline Randomization will be blinded to investigators to prevent bias and ensure balance in treatment arms throughout the study Participants surgeons clinicians and raters will be blinded with respect to treatment assignments The investigational pharmacy will prepare the study drug based on the randomization assignment received
The investigators will identify patients who have been scheduled for an elective minimally invasive hysterectomy at Brigham and Womens Hospital by reviewing the operating room booking schedule
Patients will be pre-screened for inclusion and exclusion criteria Subsequently they will be recruited for participation in this study by phone MGB Zoom and will be consented by electronic consent
Once the patient is recruited and consented they will be randomized for either the intervention group oxytocin IV infusion or the control group 09 normal saline IV infusion
An email will be sent to those who consent with a link to the secure REDCap system containing a set of baseline questionnaires to assess relevant medical and surgical history pre-operative pain analgesic medication use and psychosocial variables
Both groups intervention and control will be treated pre-operatively with the following Early Recovery After Surgery ERAS medications as per usual institutional practice
acetaminophen 1000 mg orally
celecoxib 400 mg orally The Investigational Research Pharmacy will be informed and prepare blinded infusions for perioperative administration oxytocin or placebo
The primary anesthesiology team will receive either the study medication or placebo in a 500 ml bag labeled as Oxytocin Study Drug for IV infusion
A recommended Intra-Operative Analgesia Management algorithm will be given to the primary anesthetic team The recommended algorithm for intra-operative analgesia management will include the following
Fentanyl 100 mcg IV for induction
Dexamethasone 8 mg IV after induction but prior to skin incision
Small titrated doses of Hydromorphone IV boluses 02-04 mg during the operation and before emergence according to primary team judgment
Ketorolac 30 mg IV prior to skin closure unless otherwise contraindicated
Avoidance of other multimodal analgesic agents not included in this protocol to limit confounders
The infusion will be started after the skin incision and will continue until the infusion is completed or the post-anesthesia care unit PACU criteria are met whichever occurs first
Other aspects of each patients routine clinical care will continue as per standard care at the attending physicians discretion under whom the patient is admitted regardless of treatment arm status
In the PACU a brief postoperative pain questionnaire will be performed including the Surgical Pain Scales SPS
The SPS is a validated scale consisting of 4 items that measure pain at rest during normal activities and during workexercise and quantify the unpleasantness of worst pain This scale has been validated in a number of different types of postoperative pain including women after gynecologic surgery
Vital signs numeric rating scale NRS pain scores and opioid consumption in PACU will be collected from the patients medical record
Patients whose surgery was converted to open estimated blood loss EBL 500 ml or any other surgical complication that necessitates hospitalization will be excluded from the trial
For secondary outcomes including total opioid consumption in 24 48 and 72 hours and pain scores at postoperative day POD1 2 and 3 an online survey will be done at POD1 2 and 3 and follow-up will continue until 3 months post-op
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None