AnalgesiaNCT05405049
Compared With Different Method for Postcesarean Section Analgesia
A study testing Morphine hydrochloride and Bupivacain in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Morphine hydrochloride and Bupivacain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jun 2022to 11 Nov 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant women
- 18-50 age
- ASA II
- Fullterm singular pregnancy
Who cannot join
- Neuraxial anesthesia is contraindicated,
- Allergy to the drugs to be used in the study,
- Refused to participate in the study,
- BMI>35 kg/m2
- ASA≥3
- Diabetes
Show all 16Show fewer
- Preeclampsia,
- Cardiovascular disease
- Chronic pain and neuropathic pain,
- Given opioids in the operation due to intraoperative pain,
- Switched to general anesthesia,
- Excessive bleeding during the operation,
- Uterine atony
- Drain placed in the area to be infiltrated,
- History of drug addiction and psychiatric illness,
- Understand Visual analog pain scale
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Atatürk üniversty medicine school
Erzurum, YAKUTİYE, 25100
About this study
Official title: Intraperitoneal Instillation and Wound Infiltration Compared With Intrathecal Morphine for Postcesarean Section Analgesia : A Prospective Randomized Controlled Double- Blind Trial
The aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Secondary purpose; Pain scores at 2,4,6,12,and 24 hours during movement ( moving back and forth in bed ) and rest ( lying motionless in bed )
Read the detailed description
This prospective randomized double-blind study will be planned on 46 pregnant women aged 18-50 who will undergo cesarean section with Pfannenstiel incision under spinal anesthesia with American Society of Anesthesiologists Classification (ASA) II,fullterm singular pregnancy after receiving the approval of the ethics committee of Ataturk University Medical Faculty Hospital and written approval of the patients
- Conditions
- Analgesia
- Being tested
- Morphine hydrochloride, Bupivacain
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Morphine hydrochlorideDrug
Also called Bupivacaine, fentanyl
Group M will be given a 0.5% Bupivacain Dosage Regimen with weight and height adjustment+15 μg fentanyl +150 μg morphine intrathecally.
BupivacainDrug
Also called lidocain, fentanyl
Group LWI+IPLA will given 30 ml %0,5 bupivacaine+%2 lidocaine infiltration and instillation
| Study group | Role | What they receive |
|---|---|---|
| Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI) | Active comparator | local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation Receives: Drug: Bupivacain |
| Group morphine ( M ) | Active comparator | intrathecal injection of morphine with local anesthesic Receives: Drug: Morphine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Measured: postoperative 24 hours
Secondary outcomes (1)
Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively
The VAS is a validated.Possible scores range from 0 (no pain) to 10 (worst possible pain)
Measured: 2,4,6,12,and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start16 Jun 2022
- Primary completion25 Oct 2023
- Study completion11 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aysenur Dostbil, Ataturk University
- Investigators
- ayşenur dostbil, prof, Principal investigator, Department of Anesthesiology and Reanimation.Ataturk Universty School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405049
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00/339
- Status last verified
- Jun 2022
- First submitted
- 24 May 2022
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Instillation and Wound Infiltration Compared With Intrathecal Morphine for Postcesarean Section Analgesia : A Prospective Randomized Controlled Double- Blind Trial
- ClinicalTrials.gov ID
- NCT05405049
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00/339
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 25 Oct 2023 (actual)
- Study completion
- 11 Nov 2023 (actual)
- First posted
- 3 Jun 2022 (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 aim of this study is compare the efficacy of local anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation and intrathecal injection of morphine with local anesthesic to reduce pain in women undergoing elective cesarean section under spinal anesthesia. The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Secondary purpose; Pain scores at 2,4,6,12,and 24 hours during movement ( moving back and forth in bed ) and rest ( lying motionless in bed )
Detailed description
This prospective randomized double-blind study will be planned on 46 pregnant women aged 18-50 who will undergo cesarean section with Pfannenstiel incision under spinal anesthesia with American Society of Anesthesiologists Classification (ASA) II,fullterm singular pregnancy after receiving the approval of the ethics committee of Ataturk University Medical Faculty Hospital and written approval of the patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI) | Active comparator | Drug: Bupivacainlocal anesthetic infiltration into all layers of the anterior abdominal wall and peritoneal instillation |
| Group morphine ( M ) | Active comparator | Drug: Morphine hydrochlorideintrathecal injection of morphine with local anesthesic |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pregnant women
- 18-50 age
- ASA II
- Fullterm singular pregnancy
Key exclusion criteria (16 listed)
- Neuraxial anesthesia is contraindicated,
- Allergy to the drugs to be used in the study,
- Refused to participate in the study,
- BMI>35 kg/m2
- ASA≥3
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 |
|---|---|---|
| Morphine hydrochlorideAlso: Bupivacaine, fentanylGroup M will be given a 0.5% Bupivacain Dosage Regimen with weight and height adjustment+15 μg fentanyl +150 μg morphine intrathecally. | Drug | Group morphine ( M ) |
| BupivacainAlso: lidocain, fentanylGroup LWI+IPLA will given 30 ml %0,5 bupivacaine+%2 lidocaine infiltration and instillation | Drug | Group intraperitoneal instillation of local anesthetic + local anesthetic infiltration (IPLA+ LWI) |
Primary outcome
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
Time frame: postoperative 24 hours
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively.
1 secondary outcome
Visual Analog Scale (VAS) (0-10) at 2,4,6,12 and 24 hours postoperatively
Time frame: 2,4,6,12,and 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
ayşenur dostbil, prof principal investigator
Department of Anesthesiology and Reanimation.Ataturk Universty School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Morphine hydrochloride and Bupivacain in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
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 4 inclusion and 16 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 12 Jan 2026. 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 Turkey (Türkiye). 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?
The primary outcome is to compare the total amount of opioids consumed in the first 24 hours postoperatively. (time frame: postoperative 24 hours). 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 12 Jan 2026.