Dexmedetomidine Reduce Postoperative Pain of C-section
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring Intraperitoneal spraying, Dexmedetomidine, Cesarean section, Postoperative analgesia
Eligibility Criteria
Inclusion Criteria: ASA Ⅰ or Ⅱ patients 18-50 years of age BMI<40 Term pregnancy Singleton pregnancy Spinal anesthetic Patients who have given pre-operative informed written consent Exclusion Criteria: Patients who refuse or are unable to give consent ASA>Ⅱ Multiple gestation Chronic pain allergic to any medication in the study protocol
Sites / Locations
- Zhiming ZhangRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Dexmedetomidines
Arm Description
Intraperitoneal instillation of normal saline
Intraperitoneal instillation Dexmedetomidine 5ug/ml (10ml,50ug)
Outcomes
Primary Outcome Measures
Pain Score (VAS) 48hr rest
VAS score (VAS 0-10 cm) for maternal pain on rest at 48 hours postcesarean delivery
Pain Score (VAS) 48hr movement
VAS score (VAS 0-10 cm) for maternal pain on movement at 48 hours postcesarean delivery
Secondary Outcome Measures
Pain Score (VAS) 2hr rest
VAS score (VAS 0-10 cm) for maternal pain on rest at 2 hours postcesarean delivery
Pain Score (VAS) 2hr movement
VAS score (VAS 0-10 cm) for maternal pain on movement at 2 hours postcesarean delivery
Pain Score (VAS) 24hr rest
VAS score (VAS 0-10 cm) for maternal pain on rest at 24 hours postcesarean delivery
Pain Score (VAS) 24hr movement
VAS score (VAS 0-10 cm) for maternal pain on movement at 24 hours postcesarean delivery
Effective presses of PCIA pump 48hrs
Number of effective presses of PCIA pump at 48 hours postcesarean delivery
Patient satisfaction 48hrs
Patient satisfaction at 48 hours postcesarean
Bowel function
Return of bowel function as assessed by passing flatus
Side Effect scores
Nausea, vomiting and pruritis score at 24 hours and 48 hours postcesarean delivery
Flurbiprofen Axetil consumption 48hrs
Flurbiprofen Axetil consumption within 48 hours postcesarean delivery
Full Information
NCT ID
NCT05622656
First Posted
November 12, 2022
Last Updated
November 12, 2022
Sponsor
First People's Hospital of Chenzhou
1. Study Identification
Unique Protocol Identification Number
NCT05622656
Brief Title
Dexmedetomidine Reduce Postoperative Pain of C-section
Official Title
Intraperitoneal Installation of Can Enhance Postoperative Analgesia of Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Anticipated)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
First People's Hospital of Chenzhou
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to make sure whether the infiltration of dexmedetomidine around the uterus can reduce the pain of cesarean section surgery.Studies have shown that the use of local anesthetic infiltration around the uterus can reduce pain after cesarean section surgery.In observed group, 50ug of dexmedetomidine (volume 10ml) was infiltrated around the uterus at the end of the caesarean section, while in controled group, 10ml normal saline as placebo was infiltrated around the uterus. VASs was accessed in 2h 12h,24h,48h after surgery.
Detailed Description
Cesarean section is one of the most common inpatient surgical procedures in the world, and in China, with the implementation of the comprehensive two-child policy, the number of elderly mothers and patients undergoing another cesarean section has gradually increased, and the cesarean section rate has also gradually increased; however, despite the many measures taken to control post-cesarean pain, there are still many people with inadequate pain control. Pain after cesarean delivery can have a significant negative impact on both the physical and psychological aspects of the mother and lead to complications such as thromboembolism, chronic pain and depression. Currently, a variety of methods are available to relieve post-cesarean pain, such as patient controlled intravenous analgesia (PCIA), patient controlled epidural analgesia (PCEA), transversus abdominis plane block (TAPB), etc. However, these analgesic methods are not perfect, and each has its own shortcomings. The currently prevalent ERAS concept focuses on multimodal analgesia and minimizing the use of opioids to reduce perioperative stress and reduce opioid nociceptive allergy. Compared to the technical difficulties, risks and other potential complications, abdominal medication has some advantages.
Intraperitoneal spray of local anesthetic (IPLA) has become a commonly used method of analgesia after laparotomy. Intraperitoneal administration is simple, safe, and can relieve postoperative pain, shorten the length of hospital stay, and improve comfort.
One study showed that the use of intraperitoneal infusion of lidocaine (400 mg) improved pain management in the early postoperative period after cesarean section and reduced the number of patients requiring systemic opioids in the immediate postpartum period. It has also been demonstrated that in patients undergoing bariatric surgery, intraoperative intraperitoneal spraying of ropivacaine resulted in effective postoperative pain relief, less need for morphine postoperatively, earlier activity and feeding, and shorter hospital stays, that effective pain control encouraged early bedtime, reduced the risk of thrombosis, and reduced pulmonary complications such as atelectasis or pneumonia, and that 24-hour postoperative blood counts showed significantly lower leukocyte counts were significantly lower.
Dexmedetomidine is a potent, multifunctional, highly selective α2-adrenergic agonist. It has been shown in the literature that the application of dexmedetomidine can effectively reduce the perioperative stress response, significantly reduce the dosage of opioids in the perioperative period and prevent the transformation of acute postoperative pain into chronic pain. Some animal experiments have shown that dexmedetomidine alone has obvious analgesic effect when sprayed intraperitoneally with 12.5μg/kg of dexmedetomidine, the peak time is 20-30 minutes after administration, and the duration of action is 90 minutes. There are few studies on the use of dexmedetomidine alone intraperitoneally to reduce postoperative pain in the clinical setting and there is a lack of data to support its use in post-caesarean pain.
The purpose of this study was to assess the effect of intraperitoneal dexmedetomidine 50μg at the end of cesarean delivery on maternal pain scores and satisfaction in the context of a multimodal analgesic protocol.
The investigators hypothesized that intraperitoneal dexmedetomidine would reduce VAS pain scores, reduce the number of patient-administered intravenous analgesic pump uses and opioid-related side effects, and increase maternal satisfaction after cesarean delivery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
Intraperitoneal spraying, Dexmedetomidine, Cesarean section, Postoperative analgesia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intraperitoneal instillation of normal saline
Arm Title
Dexmedetomidines
Arm Type
Active Comparator
Arm Description
Intraperitoneal instillation Dexmedetomidine 5ug/ml (10ml,50ug)
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
Dexmedetomidine Hydrochloride
Intervention Description
Dexmedetomidine 0.0005%
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
0.9% Sodium Chloride Solution
Primary Outcome Measure Information:
Title
Pain Score (VAS) 48hr rest
Description
VAS score (VAS 0-10 cm) for maternal pain on rest at 48 hours postcesarean delivery
Time Frame
48 hours
Title
Pain Score (VAS) 48hr movement
Description
VAS score (VAS 0-10 cm) for maternal pain on movement at 48 hours postcesarean delivery
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain Score (VAS) 2hr rest
Description
VAS score (VAS 0-10 cm) for maternal pain on rest at 2 hours postcesarean delivery
Time Frame
2 hours
Title
Pain Score (VAS) 2hr movement
Description
VAS score (VAS 0-10 cm) for maternal pain on movement at 2 hours postcesarean delivery
Time Frame
2 hours
Title
Pain Score (VAS) 24hr rest
Description
VAS score (VAS 0-10 cm) for maternal pain on rest at 24 hours postcesarean delivery
Time Frame
24 hours
Title
Pain Score (VAS) 24hr movement
Description
VAS score (VAS 0-10 cm) for maternal pain on movement at 24 hours postcesarean delivery
Time Frame
24 hours
Title
Effective presses of PCIA pump 48hrs
Description
Number of effective presses of PCIA pump at 48 hours postcesarean delivery
Time Frame
48 hours
Title
Patient satisfaction 48hrs
Description
Patient satisfaction at 48 hours postcesarean
Time Frame
48 hours
Title
Bowel function
Description
Return of bowel function as assessed by passing flatus
Time Frame
48 hours
Title
Side Effect scores
Description
Nausea, vomiting and pruritis score at 24 hours and 48 hours postcesarean delivery
Time Frame
48 hours
Title
Flurbiprofen Axetil consumption 48hrs
Description
Flurbiprofen Axetil consumption within 48 hours postcesarean delivery
Time Frame
48 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
ASA Ⅰ or Ⅱ patients
18-50 years of age
BMI<40
Term pregnancy
Singleton pregnancy
Spinal anesthetic
Patients who have given pre-operative informed written consent
Exclusion Criteria:
Patients who refuse or are unable to give consent
ASA>Ⅱ
Multiple gestation
Chronic pain
allergic to any medication in the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhiming Zhang, Ph.D
Phone
13875555649
Email
otc0735@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yuan Qin, MD
Phone
13657381087
Email
uscqinyuan@163.com
Facility Information:
Facility Name
Zhiming Zhang
City
Chenzhou
State/Province
Hunan
ZIP/Postal Code
423000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhang Zhiming, M.D.
Phone
+8613875555649
Email
otc0735@163.com
12. IPD Sharing Statement
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Dexmedetomidine Reduce Postoperative Pain of C-section
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