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Multimodal AnalgesiaNCT05700045

TAP Using Dexmedetomidine and Ropivacaine for Cesarean Section Analgesia

A study testing Dexmedetomidine in people with Multimodal Analgesia and Cesarean Section, run by Xijing Hospital at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the effect of dexmedetomidine as an adjuvant of ropivacaine in the TAP block on cesarean section parturients under multimodal analgesia, optimize the multimodal analgesia program for cesarean section, and guide perioperative analgesia managemen。This is a single center, double-blind, randomized clinical… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Multimodal Analgesia, Cesarean Section
What is being tested?
Dexmedetomidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
2 sitesChina
Study dates
31 May 2023to 30 Sep 2023
Phase
Interventional
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 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1) 37-42 weeks of gestation
  • 2) Plan cesarean section
  • 3) Receiving patient controlled intravenous analgesia
  • 4) Age>18 years
  • 5) ASA（American Society of Anesthesiologists) grade I-III
  • 6) Voluntary participation and informed consent

Who cannot join

  • 1)The anesthesia method for cesarean section is general anesthesia or intraspinal anesthesia, and epidural administration is used
  • 2) Combined with other opioids during operation
  • 3) High risk pregnancy (multiple pregnancy, in vitro pregnancy, etc.) or pregnancy related complications (hypertension, preeclampsia, chorioamnionitis, etc.)
  • 4) Times of previous cesarean section ≥ 3
  • 5) BMI ≥ 50kg/m2 is not suitable for TAP block
  • 6) Allergies or contraindications to the drugs involved in the study
Show all 11Show fewer
  • 7) Combined with operations other than tubal ligation and ovariectomy
  • 8) Severe renal function impairment (SCR>176 µ mol/L and/or blood urea nitrogen>17.9 mmol/L), severe liver function impairment (ALT and/or aspartate aminotransferase exceed 3 times the upper limit of normal value)
  • 9) Increased risk of coagulation dysfunction or bleeding (PLT<80 × 109/L or international normalized ratio> 1.5)
  • 10) History of chronic pain or opiate abuse
  • 11) Other clinical trials in the last three months

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • The Fourth military medical university, Xijing Hospital

    Xi'an, Shannxi, 710032

  • Huang Nie

    Xi'an, 710032

Other trials in China

About this study

Official title: Effect of Dexmedetomidine Combined With Ropivacaine Transverse Abdominal Plane Block (TAP) on Opioid Dosage After Cesarean Section Under Multimodal Analgesia

To evaluate the effect of dexmedetomidine as an adjuvant of ropivacaine in the TAP block on cesarean section parturients under multimodal analgesia, optimize the multimodal analgesia program for cesarean section, and guide perioperative analgesia managemen。This is a single center, double-blind, randomized clinical trial.

Being tested
Dexmedetomidine
Keywords
dexmedetomidine, transversus abdominis plane block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05700045
Study groupRoleWhat they receive
dexmedetomidine + ropivacaineExperimentaleach side dexmedetomidine 0.5ug/kg+0.25% ropivacaine 20ml TAP block
Receives: Drug: Dexmedetomidine
ropivacaineNo interventioneach side 0.25% ropivacaine 20ml TAP block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Consumption of hydromorphone

    Consumption of hydromorphone 48 hours after surgery

    Measured: 48 hours after surgery

Secondary outcomes (6)

  1. Consumption of hydromorphone

    Consumption of hydromorphone 24 hours after surgery

    Measured: 24 hours after surgery

  2. First time to press bolus

    Time between end of surgery and first time to press bolus

    Measured: 48 hours after surgery

  3. Attempts of pressing bolus

    Attempts of pressing bolus at 4 hours, 12 hours, 24 hours and 48 hours after surgery respectively

    Measured: 48 hours after surgery

  4. Numeric Rating Scale

    Numeric rating scale sores at rest , ambulation and uterine contraction. Postoperative pain will be scored on a scale of 0 to 10 on the NRS, with nil (0) representing no pain and 10 representing the worst imaginable pain.

    Measured: 48 hours after surgery

  5. Postoperative satisfaction

    Self-planned satisfaction with postoperative analgesia 0 point: dissatisfied, persistent pain, unable to sleep;

    1. point: satisfied, slight pain, pain when breathing deeply or coughing;
    2. points: very satisfied, painless when breathing deeply or coughing, quiet to sleep

    Measured: 48 hours after surgery

  6. Postoperative Ramsay score

    It divides a patient's level of sedation into six categories ranging from severe agitation to deep coma. Level 1 sober: the patient is anxious, restless or irritable; Level 2 sober: the patient is cooperative, has good orientation or is quiet; Level 3 sober: the patient only responds to commands; Level 4 sleep: the patient responds quickly to light tapping between the eyebrows or strong sound stimulation; Grade 5 sleep: the patient is slow to respond to light tapping between the eyebrows or strong sound stimulation; Grade 6 sleep: the patient has no response to light tapping between the eyebrows or strong sound stimulation.

    Measured: 48 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start31 May 2023
  3. Primary completion28 Sep 2023
  4. Study completion30 Sep 2023

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05700045
Sponsor's protocol ID
KY-20222263-F-1
Status last verified
Nov 2022
First submitted
26 Dec 2022
Last updated
11 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang Y, Wang L, Wang Y, Mu X, Zhao B, Liu T, Nie H. Dexmedetomidine as adjuvant of transversus abdominal plane block for cesarean delivery under multimodal analgesia: a randomized clinical trial. BMC Anesthesiol. 2026 Jan 23;26(1):147. doi: 10.1186/s12871-026-03642-0.

    PubMed 41578187

Questions about this trial

What is this clinical trial studying?

A study testing Dexmedetomidine in people with Multimodal Analgesia and Cesarean Section, run by Xijing Hospital at 2 sites 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 6 inclusion and 11 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: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Consumption of hydromorphone (time frame: 48 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05700045, which also lists 1 linked publication.

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 11 Oct 2023.

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