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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Zhiming Zhang, Ph.D contact

13875555649

otc0735@163.com

Yuan Qin, MD contact

13657381087

uscqinyuan@163.com

China1 site, 1 recruiting
  • Zhiming Zhang

    Chenzhou, Hunan, 423000

    Zhang Zhiming, M.D., +8613875555649, otc0735@163.com

    Recruiting

Other trials in China

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.

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 groups in NCT05622656
Study groupRoleWhat they receive
PlaceboPlacebo comparatorIntraperitoneal instillation of normal saline
Receives: Drug: Placebo
DexmedetomidinesActive comparatorIntraperitoneal 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.

  1. Pain Score (VAS) 48hr rest

    VAS score (VAS 0-10 cm) for maternal pain on rest at 48 hours postcesarean delivery

    Measured: 48 hours

  2. 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)
  1. Pain Score (VAS) 2hr rest

    VAS score (VAS 0-10 cm) for maternal pain on rest at 2 hours postcesarean delivery

    Measured: 2 hours

  2. Pain Score (VAS) 2hr movement

    VAS score (VAS 0-10 cm) for maternal pain on movement at 2 hours postcesarean delivery

    Measured: 2 hours

  3. Pain Score (VAS) 24hr rest

    VAS score (VAS 0-10 cm) for maternal pain on rest at 24 hours postcesarean delivery

    Measured: 24 hours

  4. Pain Score (VAS) 24hr movement

    VAS score (VAS 0-10 cm) for maternal pain on movement at 24 hours postcesarean delivery

    Measured: 24 hours

  5. Effective presses of PCIA pump 48hrs

    Number of effective presses of PCIA pump at 48 hours postcesarean delivery

    Measured: 48 hours

  6. Patient satisfaction 48hrs

    Patient satisfaction at 48 hours postcesarean

    Measured: 48 hours

  7. Bowel function

    Return of bowel function as assessed by passing flatus

    Measured: 48 hours

  8. Side Effect scores

    Nausea, vomiting and pruritis score at 24 hours and 48 hours postcesarean delivery

    Measured: 48 hours

  9. 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.

  1. First posted18 Nov 2022
  2. Study start1 Dec 2022 (estimated)
  3. Primary completion31 Mar 2023 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

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)
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

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.

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