Postoperative PainNCT03382938
Dexmedetomidine Wound Infiltration in Cesarean Section
A study testing Dexmedetomidine, Ropivacaine and Dexmedetomidine - Ropivacaine in people with Postoperative Pain, run by Attikon Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexmedetomidine, Ropivacaine and Dexmedetomidine - Ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGreece
- Study dates
- 23 Aug 2019to 20 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnancy >37 weeks, ASA I-II, BMI<35
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
Paraskevi K Matsota
Athens, Other, 13231
Paraskevi K Matsota, Assoc Prof, 00306945544563, matsota@yahoo.gr
Paraskevi Mastota, MD, PhD
About this study
Official title: Wound Infiltration With Dexmedetomidine in Cesarean Section: Effect on Postoperative Analgesia
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).
Read the detailed description
Parturients undergoing scheduled cesarean section under combined spinal-epidural anesthesia will be included in the study. Women will be randomly allocated according to the type of the solution used for wound infiltration into one of the following four groups using the closed envelop method.
Group DEX: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of dexmedetomidine 1γ/kg within Normal Saline will be infiltrated subcutaneously along the skin wound edges.
Group ROPI: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of ropivacaine 0.375% will be infiltrated subcutaneously along the skin wound edges.
Group DEX-ROPI: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% will be infiltrated subcutaneously along the skin wound edges.
Placebo Group: Following the closure of the uterine incision and the rectus fascia, 20 ml with 0.9 % saline solution will be infiltrated subcutaneously along the skin wound edges.
In Postanesthesia Care Unit, 2 mg of morphine will be administered bolus epidurally before the removal of the epidural catheter. Postoperative analgesia will be managed with the systematic administration of intravenous paracetamol 1g x 3 /day, oral celecoxib 200mg x 2 /day and PCA morphine (1 mg/ml) (setting: bolus dose 1 ml every 7 min). The total morphine consumption 24 hours after the PCA device initiation will be recorded.
Also, ranitidine 50 mg and metoclopramide 10 mg will be given intravenously twice per day, while ondansetron 4 mg will be prescribed to be administered intravenously in case of postoperative nausea or vomiting (max x 3 times/day).
Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10) at 1, 3, 6, 12, 18 and 24 hours after the end of surgery from an anesthesiologist who does not know the group assignment. Also, at the same time points, hemodynamic parameters of the parturients, side effects (nausea, vomiting, sedation, pruritus) and complications (fever, infection in the area of the wound infiltration, bleeding) will be recorded, while 24 hours postoperatively the overall patient' satisfaction with her postoperative analgesia management will be assessed using a 4 point scale.
- Conditions
- Postoperative Pain
- Being tested
- Dexmedetomidine, Ropivacaine, Dexmedetomidine - Ropivacaine, 0,9% saline
- Keywords
- dexmedetomidine, ropivacaine, wound infiltration, ceasarean section
- 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 Dexmed
WOUND INFILTRATION IN CESAREAN SECTION
RopivacaineDrug
Also called Ropi
WOUND INFILTRATION IN CESAREAN SECTION
Dexmedetomidine - RopivacaineDrug
Also called Dexmed Ropi
WOUND INFILTRATION IN CESAREAN SECTION
0,9% salineOther
Also called normal saline
placebo WOUND INFILTRATION IN CESAREAN SECTION
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: dexmedetomidine (Dexmed) 20 mL solution of dexmedetomidine used for wound infiltration Receives: Drug: Dexmedetomidine |
| Ropivacaine | Active comparator | Drug: ropivacaine 20 mL solution of ropivacaine 0.375% used for wound infiltration Receives: 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 Receives: 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 Receives: Other: 0,9% saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10)
Measured: up to 24 hours after the end of surgery
Secondary outcomes (2)
morphine consumption
morphine given by PCA (1 mg/ml)(setting: bolus dose 1 ml every 7 min).
Measured: 24 hours after the PCA device initiation will be recorded
overall patient satisfaction
overall patient satisfaction with postoperative analgesia using a 4 point scale
Measured: 24 hours after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start23 Aug 2019
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Attikon Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paraskevi Matsota, Attikon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382938
- Sponsor's protocol ID
- WIWDICS
- Status last verified
- Mar 2025
- First submitted
- 17 Dec 2017
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wound Infiltration With Dexmedetomidine in Cesarean Section: Effect on Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT03382938
- Acronym / sponsor ID
- WIWDICS
- Conditions
- Postoperative Pain
- Keywords
- dexmedetomidine, ropivacaine, wound infiltration, ceasarean section
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Attikon HospitalUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 26 Dec 2017 (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 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).
Detailed description
Parturients undergoing scheduled cesarean section under combined spinal-epidural anesthesia will be included in the study. Women will be randomly allocated according to the type of the solution used for wound infiltration into one of the following four groups using the closed envelop method.
Group DEX: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of dexmedetomidine 1γ/kg within Normal Saline will be infiltrated subcutaneously along the skin wound edges.
Group ROPI: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of ropivacaine 0.375% will be infiltrated subcutaneously along the skin wound edges.
Group DEX-ROPI: Following the closure of the uterine incision and the rectus fascia, 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% will be infiltrated subcutaneously along the skin wound edges.
Placebo Group: Following the closure of the uterine incision and the rectus fascia, 20 ml with 0.9 % saline solution will be infiltrated subcutaneously along the skin wound edges.
In Postanesthesia Care Unit, 2 mg of morphine will be administered bolus epidurally before the removal of the epidural catheter. Postoperative analgesia will be managed with the systematic administration of intravenous paracetamol 1g x 3 /day, oral celecoxib 200mg x 2 /day and PCA morphine (1 mg/ml) (setting: bolus dose 1 ml every 7 min). The total morphine consumption 24 hours after the PCA device initiation will be recorded.
Also, ranitidine 50 mg and metoclopramide 10 mg will be given intravenously twice per day, while ondansetron 4 mg will be prescribed to be administered intravenously in case of postoperative nausea or vomiting (max x 3 times/day).
Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10) at 1, 3, 6, 12, 18 and 24 hours after the end of surgery from an anesthesiologist who does not know the group assignment. Also, at the same time points, hemodynamic parameters of the parturients, side effects (nausea, vomiting, sedation, pruritus) and complications (fever, infection in the area of the wound infiltration, bleeding) will be recorded, while 24 hours postoperatively the overall patient' satisfaction with her postoperative analgesia management will be assessed using a 4 point scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Active comparator | Drug: DexmedetomidineDrug: dexmedetomidine (Dexmed) 20 mL solution of dexmedetomidine used for wound infiltration |
| Ropivacaine | Active comparator | Drug: RopivacaineDrug: ropivacaine 20 mL solution of ropivacaine 0.375% used for wound infiltration |
| Dexmedetomidine - Ropivacaine | Active comparator | Drug: Dexmedetomidine - RopivacaineDrug: dexmedetomidine (Dexmed) combined with Drug: ropivacaine 20 mL solution of dexmedetomidine 1γ/kg within ropivacaine 0.375% used for wound infiltration |
| 0.9 % saline | Placebo comparator | Other: 0,9% salineDrug:0.9 % saline solution (Normal saline). 20 ml with 0.9 % saline solution used for wound infiltration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnancy >37 weeks, ASA I-II, BMI<35
Key exclusion criteria (1 listed)
- 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
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: DexmedWOUND INFILTRATION IN CESAREAN SECTION | Drug | Dexmedetomidine |
| RopivacaineAlso: RopiWOUND INFILTRATION IN CESAREAN SECTION | Drug | Ropivacaine |
| Dexmedetomidine - RopivacaineAlso: Dexmed RopiWOUND INFILTRATION IN CESAREAN SECTION | Drug | Dexmedetomidine - Ropivacaine |
| 0,9% salineAlso: normal salineplacebo WOUND INFILTRATION IN CESAREAN SECTION | Other | 0.9 % saline |
Primary outcome
Pain score
Time frame: up to 24 hours after the end of surgery
Postoperative pain will be assessed in rest and mobilization using the Visual Analogue Scale (VAS, 0-10)
2 secondary outcomes
morphine consumption
Time frame: 24 hours after the PCA device initiation will be recorded
overall patient satisfaction
Time frame: 24 hours after the end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, Ropivacaine and Dexmedetomidine - Ropivacaine in people with Postoperative Pain, run by Attikon Hospital at 1 site in Greece.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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 Greece. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: up to 24 hours after the end of surgery). 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 19 Mar 2025.