Pain, PostoperativeNCT03156322
Different Epidural Initiation Volumes
A study testing 5 mL epidural initiation volume (bupivacaine + fentanyl), 10 mL epidural initiation volume (bupivacaine + fentanyl) and 20 mL epidural initiation volume (bupivacaine + fentanyl) in people with Pain, Postoperative, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- 5 mL epidural initiation volume (bupivacaine + fentanyl), 10 mL epidural initiation volume (bupivacaine + fentanyl) and 20 mL epidural initiation volume (bupivacaine + fentanyl)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2016to 1 Jan 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiology risks classification II
- Term pregnant
Who cannot join
- Multiple pregnancy
- Diabetes mellitus
- Hypertension
- Coagulopathy
- Severe cardiac, neurological and pulmonary disease
- Allergy to the study drugs
- Difficulty in understanding the use of the patient controlled analgesia device
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Inonu University Turgut Ozal Medical Center
Malatya
About this study
Official title: Effects of Different Epidural Initiation Volumes on Postoperative Analgesia in Cesarean Delivery
The aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.
Read the detailed description
90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered.
The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.
- Conditions
- Pain, Postoperative
- Being tested
- 5 mL epidural initiation volume (bupivacaine + fentanyl), 10 mL epidural initiation volume (bupivacaine + fentanyl), 20 mL epidural initiation volume (bupivacaine + fentanyl)
- Keywords
- cesarean section, combined spinal epidural anesthesia, patient controlled epidural analgesia, postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mL epidural initiation volume (bupivacaine + fentanyl)Drug
Also called Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter
10 mL epidural initiation volume (bupivacaine + fentanyl)Drug
Also called Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter
20 mL epidural initiation volume (bupivacaine + fentanyl)Drug
Also called Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)
20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter
| Study group | Role | What they receive |
|---|---|---|
| Group 5 | Active comparator | 5 mL epidural initiation volume (bupivacaine + fentanyl) Receives: Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl) |
| Group 10 | Active comparator | 10 mL epidural initiation volume (bupivacaine + fentanyl) Receives: Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl) |
| Group 20 | Active comparator | 20 mL epidural initiation volume (bupivacaine + fentanyl) Receives: Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postoperative pain scores
Visual analog scale
Measured: up to 12 hours after cesarean delivery
Secondary outcomes (3)
First analgesic demand time
Time to first analgesic requirement (first patient controlled epidural analgesic demand time)
Measured: up to 12 hours after cesarean delivery
The number of analgesic requirement
The number of patient controlled epidural analgesic requirement per hour
Measured: up to 12 hours after cesarean delivery
Morphine requirement
Intravenous morphine administration
Measured: up to 12 hours after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2017
- Study start1 Jan 2016
- Primary completion1 Dec 2016
- Study completion1 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Kacmaz, Inonu University
- Investigators
- Mahmut Durmus, Prof, Study chair, Prof Dr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03156322
- Sponsor's protocol ID
- Inonu Anesthesia
- Status last verified
- May 2017
- First submitted
- 9 May 2017
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sng BL, Woo D, Leong WL, Wang H, Assam PN, Sia AT. Comparison of computer-integrated patient-controlled epidural analgesia with no initial basal infusion versus moderate basal infusion for labor and delivery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2014 Oct;30(4):496-501. doi: 10.4103/0970-9185.142842.
PubMed 25425774
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Epidural Initiation Volumes on Postoperative Analgesia in Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03156322
- Acronym / sponsor ID
- Inonu Anesthesia
- Conditions
- Pain, Postoperative
- Keywords
- cesarean section, combined spinal epidural anesthesia, patient controlled epidural analgesia, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 17 May 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 aim of this study is to compare the effect of different epidural initiation volumes on postoperative pain scores, local anesthetic requirements, and motor block in patients who undergo patient controlled epidural analgesia for postoperative pain after cesarean section.
Detailed description
90 minutes after combined epidural spinal catheter insertion, three different volumes (5 mL, 10 mL, and 20 mL) are administered with a patient-controlled epidural analgesia (PCEA) device through the epidural catheter. For each group, 0.625% bupivacain + 2 μg/mL fentanyl, is administered.
The visual analog scale, first analgesic demand time, the number of PCEA requirement per hour, morphine requirement, nausea-vomiting, itching, motor block, hypotension, and total consumed analgesic, and ephedrine amounts of the patients are recorded in the recovery room and at postoperative 2, 4, 6, 12 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 5 | Active comparator | Drug: 5 mL epidural initiation volume (bupivacaine + fentanyl)5 mL epidural initiation volume (bupivacaine + fentanyl) |
| Group 10 | Active comparator | Drug: 10 mL epidural initiation volume (bupivacaine + fentanyl)10 mL epidural initiation volume (bupivacaine + fentanyl) |
| Group 20 | Active comparator | Drug: 20 mL epidural initiation volume (bupivacaine + fentanyl)20 mL epidural initiation volume (bupivacaine + fentanyl) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiology risks classification II
- Term pregnant
Key exclusion criteria (7 listed)
- Multiple pregnancy
- Diabetes mellitus
- Hypertension
- Coagulopathy
- Severe cardiac, neurological and pulmonary disease
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 |
|---|---|---|
| 5 mL epidural initiation volume (bupivacaine + fentanyl)Also: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter | Drug | Group 5 |
| 10 mL epidural initiation volume (bupivacaine + fentanyl)Also: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter | Drug | Group 10 |
| 20 mL epidural initiation volume (bupivacaine + fentanyl)Also: Bupivacaine(Marcaine 0.5%), Fentanyl(Talinat 0.5mg/10mL)20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter | Drug | Group 20 |
Primary outcome
Change in postoperative pain scores
Time frame: up to 12 hours after cesarean delivery
Visual analog scale
3 secondary outcomes
First analgesic demand time
Time frame: up to 12 hours after cesarean delivery
The number of analgesic requirement
Time frame: up to 12 hours after cesarean delivery
Morphine requirement
Time frame: up to 12 hours after cesarean delivery
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 18 May 2017.
- Results publication: PubMed 25425774Sng BL, Woo D, Leong WL, Wang H, Assam PN, Sia AT. Comparison of computer-integrated patient-controlled epidural analgesia with no initial basal infusion versus moderate basal infusion for labor and delivery: A randomized controlled trial. J Anaesthesiol Clin Pharmacol. 2014 Oct;30(4):496-501. doi: 10.4103/0970-9185.142842.
- 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.
Mahmut Durmus, Prof study chair
Prof Dr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 mL epidural initiation volume (bupivacaine + fentanyl), 10 mL epidural initiation volume (bupivacaine + fentanyl) and 20 mL epidural initiation volume (bupivacaine + fentanyl) in people with Pain, Postoperative, run by Inonu 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 2 inclusion and 7 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 18 May 2017. 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?
Change in postoperative pain scores (time frame: up to 12 hours after cesarean delivery). 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 NCT03156322, 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 18 May 2017.