Ignite Creation Date:
2024-05-06 @ 10:08 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03178058
Status:
UNKNOWN
Last Update Posted:
2017-06-06
First Post:
2017-05-09
Brief Title:
Risk Factors for Postoperative Nausea Vomiting and Pruritus
Sponsor:
Rabin Medical Center
Organization:
Rabin Medical Center
Study Overview
Official Title:
Risk Factors for Nausea Vomiting and Pruritus After Neuraxial Morphine for Cesarean Section
Status:
UNKNOWN
Status Verified Date:
2017-06
Last Known Status:
RECRUITING
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:
In this study we would like to identify demographic and individual risk factors that place parturients at a higher risk for postoperative nausea and vomiting PONV and itching following administered neuraxial morphine for cesarean section Our primary objective is to develop a reliable predictive neuraxial morphine induced nausea and vomiting NMINV and itching model
Detailed Description:
Introduction Neuraxial morphine provides effective and long-lasting analgesia after cesarean section It is currently considered the gold standard for postoperative pain However it is associated with problematic side effects including nausea and vomiting pruritus and rarely respiratory depression
Postoperative nausea and vomiting PONV occurs in up to 60-80 of parturients receiving neuraxial opioid administration and reported incidence of pruritus varies from 30 to 100
A wide range of pharmaceutical and non pharmaceutical agents are commonly used in clinical practice for the treatment and prophylaxis of neuraxial morphine induced postoperative nausea vomiting and pruritus Antiemetic medications such as droperidol dexamethasone metoclopramide and ondansetron have been studied for their efficacy in preventing PONV Despite the wide variety of these available drugs many of them are ineffective and have side effects Dexamethasone for example although it has been proven as an effective antiemetic in patients receiving epidural morphine it is ineffective monotherapy in patients receiving intrathecal morphine In addition it is associated severe perineal pruritus Common side effects of ondansetron are headache flushing dizziness and constipation Droperidol is associated with undesirable side effects sedation hypotension and extrapy-ramidal reactions Both droperidol and ondansetron are known to prolong the QTc interval
To date although pruritus after neuraxial administration of morphine is a common side effect there is little available effective treatment Studies have found opioid-induced pruritus to be dose dependent and minimal analgesic doses of opioids are recommended Several agents from numerous drug families have been employed although none has proved to be totally effective Treatment medications include naloxone nalbuphine diphenhydramine and droperidol
To date there are no studies which have identified risk factors for PONV and pruritus after administration of nauraxial morphine Attempts have been made to identify which patients are at risk for PONV after general anesthesia
There are anesthetic surgical and individual risk factors are linked to PONV Studies in this field have identified several predicting risk factors for PONV
Apfel et al established a validated simplified scoring systems to assess risk factors for nausea and vomiting after general anesthesia His simplified sum score system included four risk factors female gender prior history of motion sickness or PONV nonsmoking and the use of postoperative opioids
If none or only one risk factor is present the predicted incidence of PONV may vary between about 10 and 21 whereas if at least two risk factors are present it increases to between 39 and 78
To date research has yet to yield a predictive model for neuraxial morphine induced nausea and vomiting NMINV Likewise risk factor for neuraxial itching have yet to be established
Methods This is a prospective single center study which will be conducted at the Rabin Medical Center Beilinson Campus Petach Tikva Israel a tertiary university hospital The Institutional Review Board has approved this study
All women undergoing cesarean section delivery under spinal anesthesia with neuraxial morphine will be enrolled after filling out an informed consent prior to surgery Women undergo spinal anesthesia with 10-12 mg heavy bupivicaine 20 ucg fentanyl and 100 ucg morphine Phenylepherine drip is used at anesthesiologists discretion If not treatment dose of ephedrine or phenylepherine are given as required by blood pressure
All women receive prophylaxis intravenous dexamenthasone 4 mg and prophylactic intravenous ondansetron 4mg as standard departmental protocol
Prior to surgery women will be given a questionnaire detailing previous motion sickness previous history of PONV emesis during pregnancy smoking history itching history skin atopy and allergies After surgery details about surgery will be added intraoperative hypotension use of phenylepherine intraoperative nausea and vomiting exteriorization of uterus extent of adhesions need for uterotonic medications and estimated bleeding
Parturients will be assessed 1 hour and 24 postoperatively by attending anesthesiologist PONV incidence will be reported using a three point ordinal scale 0 none 1 nausea 2 retching 3 vomiting
Nausea includes any feeling of sickness with an inclination to vomit Retching includes any reverse movement of the stomach and esophagus without vomiting including attempting vomiting
Vomiting is defined as the involuntary forceful expulsion of ones gastric contents through the mouth and sometimes the nose
A VNRS vas numerical rating score from 0-10 0 no itching at all 10 worst itching possible will be used to measure overall presence and severity of pruritus
Any severe incidence of VNRS defined above 7 will be noted All parturients need for postoperative antiemetic and antipruritic medications will be reported
Postoperative nausea and vomiting PONV occurs in up to 60-80 of parturients receiving neuraxial opioid administration and reported incidence of pruritus varies from 30 to 100
A wide range of pharmaceutical and non pharmaceutical agents are commonly used in clinical practice for the treatment and prophylaxis of neuraxial morphine induced postoperative nausea vomiting and pruritus Antiemetic medications such as droperidol dexamethasone metoclopramide and ondansetron have been studied for their efficacy in preventing PONV Despite the wide variety of these available drugs many of them are ineffective and have side effects Dexamethasone for example although it has been proven as an effective antiemetic in patients receiving epidural morphine it is ineffective monotherapy in patients receiving intrathecal morphine In addition it is associated severe perineal pruritus Common side effects of ondansetron are headache flushing dizziness and constipation Droperidol is associated with undesirable side effects sedation hypotension and extrapy-ramidal reactions Both droperidol and ondansetron are known to prolong the QTc interval
To date although pruritus after neuraxial administration of morphine is a common side effect there is little available effective treatment Studies have found opioid-induced pruritus to be dose dependent and minimal analgesic doses of opioids are recommended Several agents from numerous drug families have been employed although none has proved to be totally effective Treatment medications include naloxone nalbuphine diphenhydramine and droperidol
To date there are no studies which have identified risk factors for PONV and pruritus after administration of nauraxial morphine Attempts have been made to identify which patients are at risk for PONV after general anesthesia
There are anesthetic surgical and individual risk factors are linked to PONV Studies in this field have identified several predicting risk factors for PONV
Apfel et al established a validated simplified scoring systems to assess risk factors for nausea and vomiting after general anesthesia His simplified sum score system included four risk factors female gender prior history of motion sickness or PONV nonsmoking and the use of postoperative opioids
If none or only one risk factor is present the predicted incidence of PONV may vary between about 10 and 21 whereas if at least two risk factors are present it increases to between 39 and 78
To date research has yet to yield a predictive model for neuraxial morphine induced nausea and vomiting NMINV Likewise risk factor for neuraxial itching have yet to be established
Methods This is a prospective single center study which will be conducted at the Rabin Medical Center Beilinson Campus Petach Tikva Israel a tertiary university hospital The Institutional Review Board has approved this study
All women undergoing cesarean section delivery under spinal anesthesia with neuraxial morphine will be enrolled after filling out an informed consent prior to surgery Women undergo spinal anesthesia with 10-12 mg heavy bupivicaine 20 ucg fentanyl and 100 ucg morphine Phenylepherine drip is used at anesthesiologists discretion If not treatment dose of ephedrine or phenylepherine are given as required by blood pressure
All women receive prophylaxis intravenous dexamenthasone 4 mg and prophylactic intravenous ondansetron 4mg as standard departmental protocol
Prior to surgery women will be given a questionnaire detailing previous motion sickness previous history of PONV emesis during pregnancy smoking history itching history skin atopy and allergies After surgery details about surgery will be added intraoperative hypotension use of phenylepherine intraoperative nausea and vomiting exteriorization of uterus extent of adhesions need for uterotonic medications and estimated bleeding
Parturients will be assessed 1 hour and 24 postoperatively by attending anesthesiologist PONV incidence will be reported using a three point ordinal scale 0 none 1 nausea 2 retching 3 vomiting
Nausea includes any feeling of sickness with an inclination to vomit Retching includes any reverse movement of the stomach and esophagus without vomiting including attempting vomiting
Vomiting is defined as the involuntary forceful expulsion of ones gastric contents through the mouth and sometimes the nose
A VNRS vas numerical rating score from 0-10 0 no itching at all 10 worst itching possible will be used to measure overall presence and severity of pruritus
Any severe incidence of VNRS defined above 7 will be noted All parturients need for postoperative antiemetic and antipruritic medications will be reported
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None