NCT03382938

Brief Summary

The effects of four different wound infiltration protocols in cesarean section will be investigated on parturient' pain intensity, PCA morphine consumption given, side effects and parturient' overall satisfaction. One group will receive for wound infiltration dexmedetomidine, the second ropivacaine, the third dexmedetomidine combined with ropivacaine, while the last one will receive normal saline (placebo group).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
6mo left

Started Aug 2019

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress93%
Aug 2019Nov 2026

First Submitted

Initial submission to the registry

December 17, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 26, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

August 23, 2019

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2026

Expected
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

6.3 years

First QC Date

December 17, 2017

Last Update Submit

March 16, 2025

Conditions

Postoperative Pain

Keywords

dexmedetomidineropivacainewound infiltrationceasarean section

Outcome Measures

Primary Outcomes (1)

  • Pain score

    Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10)

    up to 24 hours after the end of surgery

Secondary Outcomes (2)

  • morphine consumption

    24 hours after the PCA device initiation will be recorded

  • overall patient satisfaction

    24 hours after the end of surgery

Study Arms (4)

Dexmedetomidine

ACTIVE COMPARATOR

Drug: dexmedetomidine (Dexmed) 20 mL solution of dexmedetomidine used for wound infiltration

Drug: Dexmedetomidine

Ropivacaine

ACTIVE COMPARATOR

Drug: ropivacaine 20 mL solution of ropivacaine 0.375% used for wound infiltration

Drug: Ropivacaine

Dexmedetomidine - Ropivacaine

ACTIVE COMPARATOR

Drug: dexmedetomidine (Dexmed) combined with Drug: ropivacaine 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% used for wound infiltration

Drug: Dexmedetomidine - Ropivacaine

0.9 % saline

PLACEBO COMPARATOR

Drug:0.9 % saline solution (Normal saline). 20 ml with 0.9 % saline solution used for wound infiltration

Other: 0,9% saline

Interventions

DexmedetomidineDRUG

WOUND INFILTRATION IN CESAREAN SECTION

Also known as: Dexmed
Dexmedetomidine
RopivacaineDRUG

WOUND INFILTRATION IN CESAREAN SECTION

Also known as: Ropi
Ropivacaine
Dexmedetomidine - RopivacaineDRUG

WOUND INFILTRATION IN CESAREAN SECTION

Also known as: Dexmed Ropi
Dexmedetomidine - Ropivacaine
0,9% salineOTHER

placebo WOUND INFILTRATION IN CESAREAN SECTION

Also known as: normal saline
0.9 % saline

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pregnancy \>37 weeks, ASA I-II, BMI\<35

You may not qualify if:

  • patient refusal, epilepsy, GERD, morbid obesity, drug allergy, ASA class \>2, presence of atrioventricular block, severe systemic disease, multiple gestation, high risk pregnancy, contraindications to epidural technique, a history of severe systemic disease, recreational drug or alcohol use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paraskevi K Matsota

Athens, Other, 13231, Greece

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

DexmedetomidineRopivacaineSaline Solution

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double (Investigator, Outcomes Assessor)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof of Anaesthesiology

Study Record Dates

First Submitted

December 17, 2017

First Posted

December 26, 2017

Study Start

August 23, 2019

Primary Completion

December 20, 2025

Study Completion (Estimated)

November 20, 2026

Last Updated

March 19, 2025

Record last verified: 2025-03

Locations

GR(1)