Pain, PostoperativePhase 4NCT05622656
Dexmedetomidine Reduce Postoperative Pain of C-section
A Phase 4 study testing Dexmedetomidine in people with Pain, Postoperative, run by First People's Hospital of Chenzhou at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2022to 31 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Patients who refuse or are unable to give consent
- ASA>Ⅱ
- Multiple gestation
- Chronic pain
- allergic to any medication in the study protocol
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhiming Zhang
Chenzhou, Hunan, 423000
Zhang Zhiming, M.D., +8613875555649, otc0735@163.com
About this study
Official title: Intraperitoneal Installation of Can Enhance Postoperative Analgesia of Caesarean Section
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.
Read the 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.
- Conditions
- Pain, Postoperative
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- Intraperitoneal spraying, Dexmedetomidine, Cesarean section, Postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called Dexmedetomidine Hydrochloride
Dexmedetomidine 0.0005%
PlaceboDrug
Also called Normal saline
0.9% Sodium Chloride Solution
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Intraperitoneal instillation of normal saline Receives: Drug: Placebo |
| Dexmedetomidines | Active comparator | Intraperitoneal instillation Dexmedetomidine 5ug/ml (10ml,50ug) Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score (VAS) 48hr rest
VAS score (VAS 0-10 cm) for maternal pain on rest at 48 hours postcesarean delivery
Measured: 48 hours
Pain Score (VAS) 48hr movement
VAS score (VAS 0-10 cm) for maternal pain on movement at 48 hours postcesarean delivery
Measured: 48 hours
Secondary outcomes (9)
Pain Score (VAS) 2hr rest
VAS score (VAS 0-10 cm) for maternal pain on rest at 2 hours postcesarean delivery
Measured: 2 hours
Pain Score (VAS) 2hr movement
VAS score (VAS 0-10 cm) for maternal pain on movement at 2 hours postcesarean delivery
Measured: 2 hours
Pain Score (VAS) 24hr rest
VAS score (VAS 0-10 cm) for maternal pain on rest at 24 hours postcesarean delivery
Measured: 24 hours
Pain Score (VAS) 24hr movement
VAS score (VAS 0-10 cm) for maternal pain on movement at 24 hours postcesarean delivery
Measured: 24 hours
Effective presses of PCIA pump 48hrs
Number of effective presses of PCIA pump at 48 hours postcesarean delivery
Measured: 48 hours
Patient satisfaction 48hrs
Patient satisfaction at 48 hours postcesarean
Measured: 48 hours
Bowel function
Return of bowel function as assessed by passing flatus
Measured: 48 hours
Side Effect scores
Nausea, vomiting and pruritis score at 24 hours and 48 hours postcesarean delivery
Measured: 48 hours
Flurbiprofen Axetil consumption 48hrs
Flurbiprofen Axetil consumption within 48 hours postcesarean delivery
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start1 Dec 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Chenzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhiming zhang, First People's Hospital of Chenzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622656
- Sponsor's protocol ID
- 202002
- Status last verified
- Nov 2022
- First submitted
- 12 Nov 2022
- Last updated
- 18 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Installation of Can Enhance Postoperative Analgesia of Caesarean Section
- ClinicalTrials.gov ID
- NCT05622656
- Acronym / sponsor ID
- 202002
- Conditions
- Pain, Postoperative
- Keywords
- Intraperitoneal spraying, Dexmedetomidine, Cesarean section, Postoperative analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- First People's Hospital of ChenzhouUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 18 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboIntraperitoneal instillation of normal saline |
| Dexmedetomidines | Active comparator | Drug: DexmedetomidineIntraperitoneal instillation Dexmedetomidine 5ug/ml (10ml,50ug) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- ASA Ⅰ or Ⅱ patients
- 18-50 years of age
- BMI<40
- Term pregnancy
- Singleton pregnancy
Key exclusion criteria (5 listed)
- Patients who refuse or are unable to give consent
- ASA>Ⅱ
- Multiple gestation
- Chronic pain
- allergic to any medication in the study protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: Dexmedetomidine HydrochlorideDexmedetomidine 0.0005% | Drug | Dexmedetomidines |
| PlaceboAlso: Normal saline0.9% Sodium Chloride Solution | Drug | Placebo |
Primary outcome
Pain Score (VAS) 48hr rest
Time frame: 48 hours
VAS score (VAS 0-10 cm) for maternal pain on rest at 48 hours postcesarean delivery
Pain Score (VAS) 48hr movement
Time frame: 48 hours
VAS score (VAS 0-10 cm) for maternal pain on movement at 48 hours postcesarean delivery
9 secondary outcomes
Pain Score (VAS) 2hr rest
Time frame: 2 hours
Pain Score (VAS) 2hr movement
Time frame: 2 hours
Pain Score (VAS) 24hr rest
Time frame: 24 hours
Pain Score (VAS) 24hr movement
Time frame: 24 hours
Effective presses of PCIA pump 48hrs
Time frame: 48 hours
Patient satisfaction 48hrs
Time frame: 48 hours
Bowel function
Time frame: 48 hours
Side Effect scores
Time frame: 48 hours
Flurbiprofen Axetil consumption 48hrs
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Pain, Postoperative, run by First People's Hospital of Chenzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiming Zhang, Ph.D (13875555649, otc0735@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Score (VAS) 48hr rest (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2022.