NCT05622656

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Dec 2022

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 18, 2022

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

November 18, 2022

Status Verified

November 1, 2022

Enrollment Period

4 months

First QC Date

November 12, 2022

Last Update Submit

November 12, 2022

Conditions

Pain, Postoperative

Keywords

Intraperitoneal sprayingDexmedetomidineCesarean sectionPostoperative analgesia

Outcome Measures

Primary Outcomes (2)

  • Pain Score (VAS) 48hr rest

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

    48 hours

  • Pain Score (VAS) 48hr movement

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

    48 hours

Secondary Outcomes (9)

  • Pain Score (VAS) 2hr rest

    2 hours

  • Pain Score (VAS) 2hr movement

    2 hours

  • Pain Score (VAS) 24hr rest

    24 hours

  • Pain Score (VAS) 24hr movement

    24 hours

  • Effective presses of PCIA pump 48hrs

    48 hours

  • +4 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Intraperitoneal instillation of normal saline

Drug: Placebo

Dexmedetomidines

ACTIVE COMPARATOR

Intraperitoneal instillation Dexmedetomidine 5ug/ml (10ml,50ug)

Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

Dexmedetomidine 0.0005%

Also known as: Dexmedetomidine Hydrochloride
Dexmedetomidines
PlaceboDRUG

0.9% Sodium Chloride Solution

Also known as: Normal saline
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • ASA Ⅰ or Ⅱ patients
  • years of age
  • BMI\<40
  • Term pregnancy
  • Singleton pregnancy
  • Spinal anesthetic
  • Patients who have given pre-operative informed written consent

You may not qualify if:

  • Patients who refuse or are unable to give consent
  • ASA\>Ⅱ
  • Multiple gestation
  • Chronic pain
  • allergic to any medication in the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhiming Zhang

Chenzhou, Hunan, 423000, China

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexmedetomidineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Zhiming Zhang, Ph.D

CONTACT

13875555649otc0735@163.com

Yuan Qin, MD

CONTACT

13657381087uscqinyuan@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Ph.D

Study Record Dates

First Submitted

November 12, 2022

First Posted

November 18, 2022

Study Start

December 1, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

November 18, 2022

Record last verified: 2022-11

Locations

CN(1)