Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06433713
Status:
COMPLETED
Last Update Posted:
2024-05-30
First Post:
2024-04-24
Brief Title:
Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Effect of Intraoperative Intravenous Lidocaine on Postoperative Pain and Return of Bowel Function After Cesarean Sections a Double-blinded Randomized Control Study
Status:
COMPLETED
Status Verified Date:
2024-05
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:
Postoperative discomfort is a frequently seen adverse event after to caesarean operation Early mobilization and bonding of the mother and her infant are typically impacted by this phenomenon
Nevertheless the current state of postoperative analgesia and recovery remains inadequate in clinical settings In the context of major abdominal surgery opioids are often regarded as the preferred postoperative analgesic Nevertheless they possess adverse side effects that might impact the process of recuperation after surgery These symptoms include nausea and vomiting decreased bowel movement and shallow breathing
One additional challenging consequence after surgery is the delayed restoration of bowel function which has the potential to extend the duration of hospitalization and impede the initiation of oral feeding resulting in gaseous colonic distension
The administration of lidocaine infusion has been shown to possess analgesic anti-hyperalgesic and anti-inflammatory characteristics
The use of intravenous lidocaine after surgery is postulated to have the dual effect of mitigating postoperative pain and expediting the resumption of bowel movements
Recent studies have shown that the administration of intravenous lidocaine either as a single dosage or by continuous infusion may have potential advantages in maintaining gastrointestinal motility and exerting an impact on biochemical pain mechanisms
However the literature presents contradictory data about the effectiveness of lidocaine in providing sufficient postoperative pain relief and reducing postoperative ileus
Consequently this study was conducted and aimed to assess the effect of intravenous intraoperative lidocaine on postoperative pain and early return of bowel function following elective caesarean section
This randomized clinical trial was conducted at Obstetrics and Gynecology Department Faculty of Medicine Cairo University Hospitals from August till December 2023 A total of 60 pregnant women underwent elective caesarean section were enrolled and randomized into two groups experimental group who received IV infusion of lidocaine starting with skin incision which was maintained until skin closure and control group who received 09 normal saline at the same rate as that described in the experimental group Both groups were compared as regard total operative time medications given start-stop time of the study drug infusion and degree of pain using visual analogue scale need for analgesics time for first healing of normal intestinal sounds and time to first flatus and symptoms of lidocaine toxicity were recorded
Nevertheless the current state of postoperative analgesia and recovery remains inadequate in clinical settings In the context of major abdominal surgery opioids are often regarded as the preferred postoperative analgesic Nevertheless they possess adverse side effects that might impact the process of recuperation after surgery These symptoms include nausea and vomiting decreased bowel movement and shallow breathing
One additional challenging consequence after surgery is the delayed restoration of bowel function which has the potential to extend the duration of hospitalization and impede the initiation of oral feeding resulting in gaseous colonic distension
The administration of lidocaine infusion has been shown to possess analgesic anti-hyperalgesic and anti-inflammatory characteristics
The use of intravenous lidocaine after surgery is postulated to have the dual effect of mitigating postoperative pain and expediting the resumption of bowel movements
Recent studies have shown that the administration of intravenous lidocaine either as a single dosage or by continuous infusion may have potential advantages in maintaining gastrointestinal motility and exerting an impact on biochemical pain mechanisms
However the literature presents contradictory data about the effectiveness of lidocaine in providing sufficient postoperative pain relief and reducing postoperative ileus
Consequently this study was conducted and aimed to assess the effect of intravenous intraoperative lidocaine on postoperative pain and early return of bowel function following elective caesarean section
This randomized clinical trial was conducted at Obstetrics and Gynecology Department Faculty of Medicine Cairo University Hospitals from August till December 2023 A total of 60 pregnant women underwent elective caesarean section were enrolled and randomized into two groups experimental group who received IV infusion of lidocaine starting with skin incision which was maintained until skin closure and control group who received 09 normal saline at the same rate as that described in the experimental group Both groups were compared as regard total operative time medications given start-stop time of the study drug infusion and degree of pain using visual analogue scale need for analgesics time for first healing of normal intestinal sounds and time to first flatus and symptoms of lidocaine toxicity were recorded
Detailed Description:
None
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?:
None
Is an FDA AA801 Violation?:
None