Cesarean Section ComplicationsNCT04095013
Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section
A study testing Bupivacaine, fentanyl and Bupivacaine, dexmedetomidine in people with Cesarean Section Complications, run by Dow University of Health Sciences at 2 sites in Pakistan.
Trial summary
the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- Bupivacaine, fentanyl and Bupivacaine, dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesPakistan
- Study dates
- 1 Feb 2019to 15 Jul 2019
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Term pregnancy Singleton ASA I and II, BMI <35, elective C/section
Who cannot join
- patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Civil Hospital Karachi
Karachi, Sindh, 75520
DUHS, Civil hospital Karachi (CHK)
Karachi, Sindh, 75520
About this study
Official title: Comparative Evaluation of Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section
the primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia
Read the detailed description
The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.
- Conditions
- Cesarean Section Complications
- Being tested
- Bupivacaine, fentanyl, Bupivacaine, dexmedetomidine
- Keywords
- Elective low segment caesarean section, Intrathecal, bupivacaine-fentanyl, bupivacaine-dexmedetomidine, sensory block, complications, hemodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine, fentanylDrug
Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,
Bupivacaine, dexmedetomidineDrug
Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms
| Study group | Role | What they receive |
|---|---|---|
| Group BF | Experimental | hyperbaric Bupivacaine 10mg with fentanyl 10micrograms Receives: Drug: Bupivacaine, fentanyl |
| Group BD | Experimental | hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms Receives: Drug: Bupivacaine, dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time till T10 dermatome achieved (Sec)
Spinal block characteristics
Measured: Post operative initial hour
Time of maximum bromage achieved (Sec)
Spinal block characteristics
Measured: Post operative initial hour
Regression time to T10 dermatome (Min)
Spinal block characteristics
Measured: Post operative initial hour
Time of complete motor recovery (Min)
Spinal block characteristics
Measured: Post operative initial hour
Post-operative pain score
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
Measured: 1 hour
Post-operative pain score
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
Measured: 2 hour
Post-operative pain score
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
Measured: 3 hour
Post-operative pain score
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
Measured: 4 hour
Secondary outcomes (7)
Nausea
Sensation to throw out stomach contents
Measured: 24 hours Post operative
Vomiting
Act of throwing out stomach contents through mouth
Measured: 24 hours Post operative
Pruritus
Unpleasing sensation on the skin that provokes to scratch
Measured: 24 hours Post operative
Respiratory distress
Difficulty in breathing
Measured: 24 hours Post operative
Shivering
The act of shaking slightly and uncomfortably due to felling of cold temperature
Measured: 24 hours Post operative
Bradycardia
Heat rate less than <60 bpm
Measured: 24 hours Post operative
Hypotension
Decrease in BP greater than 20% of baseline
Measured: 24 hours Post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Feb 2019
- Primary completion15 Jun 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomize controlled trial (RCT)
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Urooj, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095013
- Sponsor's protocol ID
- dr.sanaurooj@yahoo.com
- Status last verified
- Sep 2019
- First submitted
- 14 Sep 2019
- Last updated
- 19 Sep 2019
- 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 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Intrathecal Bupivacaine-fentanyl and Bupivacaine-dexmedetomidine for Elective Low Segment Caesarean Section
- ClinicalTrials.gov ID
- NCT04095013
- Acronym / sponsor ID
- dr.sanaurooj@yahoo.com
- Conditions
- Cesarean Section Complications
- Keywords
- Elective low segment caesarean section, Intrathecal, bupivacaine-fentanyl, bupivacaine-dexmedetomidine, sensory block, complications, hemodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 19 Sep 2019 (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 primary objective of the study is to compare the onset and recovery times of sensory and motor blockade of the two study drugs intrathecally with low dose bupivacaine The secondary objectives of the study are to observe hemodynamics, side effects profile, and duration of postoperative analgesia
Detailed description
The current study is undertaken to compare the effect of two drugs intrathecally.edexmedetomidine and fentanyl with a low dose of bupivacaine and assess the adequacy of the block, side effect profile and postoperative analgesia. The two drugs have been studied separately but the comparative data is scarcely available both at national and international level. A particular agent is a dexmedetomidine that has been introduced in the investiagator's setup for the first time so this research will be of great importance in adding its multiple uses other than being used as ICU and procedural sedation agent.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomize controlled trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| Group BF | Experimental | Drug: Bupivacaine, fentanylhyperbaric Bupivacaine 10mg with fentanyl 10micrograms |
| Group BD | Experimental | Drug: Bupivacaine, dexmedetomidinehyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Term pregnancy Singleton ASA I and II, BMI <35, elective C/section
Key exclusion criteria (1 listed)
- patient refusal, contraindications to spinal anaesthesia. ASA III and IV, PIH Pre Eclampsia, allergic to Local Anesthetic, fetal anomalies.
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 |
|---|---|---|
| Bupivacaine, fentanylGroup A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms, | Drug | Group BF |
| Bupivacaine, dexmedetomidineGroup B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms | Drug | Group BD |
Primary outcome
Time till T10 dermatome achieved (Sec)
Time frame: Post operative initial hour
Spinal block characteristics
Time of maximum bromage achieved (Sec)
Time frame: Post operative initial hour
Spinal block characteristics
Regression time to T10 dermatome (Min)
Time frame: Post operative initial hour
Spinal block characteristics
Time of complete motor recovery (Min)
Time frame: Post operative initial hour
Spinal block characteristics
Post-operative pain score
Time frame: 1 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
Post-operative pain score
Time frame: 2 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
Post-operative pain score
Time frame: 3 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
Post-operative pain score
Time frame: 4 hour
VAS score indicate 0 no pain 10 severe pain. Pain score was noted down
7 secondary outcomes
Nausea
Time frame: 24 hours Post operative
Vomiting
Time frame: 24 hours Post operative
Pruritus
Time frame: 24 hours Post operative
Respiratory distress
Time frame: 24 hours Post operative
Shivering
Time frame: 24 hours Post operative
Bradycardia
Time frame: 24 hours Post operative
Hypotension
Time frame: 24 hours Post operative
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 19 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Recruiting
Clinical Impact of Uterine Repair During Cesarean Section With Barbed Suture on the Incidence of Isthmocele
Isthmocele, Cesarean Scar Defect
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, fentanyl and Bupivacaine, dexmedetomidine in people with Cesarean Section Complications, run by Dow University of Health Sciences at 2 sites in Pakistan.
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: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. 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?
Time till T10 dermatome achieved (Sec) (time frame: Post operative initial hour). The study lists 8 primary outcomes in all. 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 Sep 2019.