Cesarean SectionNCT03767920
Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section
A study testing bupivacaine and dexamethasone in people with Cesarean Section, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- bupivacaine and dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 1 Aug 2020
- 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
- healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia
Who cannot join
- Participants had known sensitivity to bupivacaine
- patient refusal,
- localized infection over injection point
- patients with significant coagulopathies and
- with contraindications to regional anesthesia,
- patients with heart diseases, altered renal or liver functions,
- psychological disorders, patients with pregnancy-induced hypertension and
- gestational diabetes, chronic use of pain medications,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial
Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section.
- Group 1: bupivacaine 0.25% + dexamethasone 8 mg
- Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.
Read the detailed description
The pain and discomfort following cesarean delivery are mostly due to the abdominal wall incision and dissection of muscles; it delays early ambulation and breastfeeding. This can lead to postoperative complications such as thromboembolic disorders. So, providing an effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia remains the most effective means of relieving pain in a wide variety of conditions; however, it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. As the analgesia and the side effects of opioids are dose-dependent, a multimodal approach may enhance analgesia, which in turn would decrease the side effects .
Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can decrease the postoperative pain following abdominal surgery. The landmarks of this block were first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under spinal anesthesia, and laparoscopic surgery.
- Conditions
- Cesarean Section
- Being tested
- bupivacaine, dexamethasone, placebo to dexamethasone
- Keywords
- dexamethasone, transversus abdominis plane block, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaineDrug
Also called Active Comparator
TAP block with 20 ml of 0.25% bupivacaine bilaterally
dexamethasoneDrug
Also called active comparator
TAP block with 4 mg dexamethasone bilaterally
placebo to dexamethasoneDrug
Also called Placebo
TAP block with 4 mg placebo to dexamethasone bilaterally
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine and dexamethasone | Active comparator | Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline. Receives: Drug: bupivacaine; Drug: dexamethasone |
| bupivacaine and placebo to dexamethasone | Active comparator | BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone Receives: Drug: bupivacaine; Drug: placebo to dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog score for pain during movement
movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain
Measured: 6 hours post operative
Secondary outcomes (3)
Visual analog score during rest
ranging from 0 to 10, where 0 no pain and 10 maximum pain
Measured: 48 hours postoperative
number of patients need Fentanyl consumption
number of patients need Fentanyl consumption
Measured: 48 hours postoperative
number of days patients stay in hospital
calculation of number of days patients stay in hospital
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Jan 2019
- Primary completion30 Mar 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies 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
- A prospective Randomized Interventional double-blind study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767920
- Sponsor's protocol ID
- aswu/180/7/18
- Status last verified
- Aug 2020
- First submitted
- 6 Dec 2018
- Last updated
- 5 Aug 2020
- Results posted
- 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 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03767920
- Acronym / sponsor ID
- aswu/180/7/18
- Conditions
- Cesarean Section
- Keywords
- dexamethasone, transversus abdominis plane block, cesarean section
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 7 Dec 2018 (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.
Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section.
- Group 1: bupivacaine 0.25% + dexamethasone 8 mg
- Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.
Detailed description
The pain and discomfort following cesarean delivery are mostly due to the abdominal wall incision and dissection of muscles; it delays early ambulation and breastfeeding. This can lead to postoperative complications such as thromboembolic disorders. So, providing an effective and safe postoperative analgesic method seems to be mandatory. Opioid analgesia remains the most effective means of relieving pain in a wide variety of conditions; however, it may cause adverse effects such as nausea, vomiting, pruritus, urinary retention, and respiratory depression. As the analgesia and the side effects of opioids are dose-dependent, a multimodal approach may enhance analgesia, which in turn would decrease the side effects .
Mc Donnell and colleagues have reported that a transversus abdominis plane (TAP) block can decrease the postoperative pain following abdominal surgery. The landmarks of this block were first described in 2001 by Rafi. The TAP block has been performed for postoperative analgesic control in patients undergoing radical prostatectomy, hysterectomy, cesarean delivery under spinal anesthesia, and laparoscopic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A prospective Randomized Interventional double-blind study.
| Arm | Type | Receives |
|---|---|---|
| bupivacaine and dexamethasone | Active comparator | Drug: bupivacaine, Drug: dexamethasoneBilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline. |
| bupivacaine and placebo to dexamethasone | Active comparator | Drug: bupivacaine, Drug: placebo to dexamethasoneBilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia
Key exclusion criteria (8 listed)
- Participants had known sensitivity to bupivacaine
- patient refusal,
- localized infection over injection point
- patients with significant coagulopathies and
- with contraindications to regional anesthesia,
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 |
|---|---|---|
| bupivacaineAlso: Active ComparatorTAP block with 20 ml of 0.25% bupivacaine bilaterally | Drug | bupivacaine and dexamethasone, bupivacaine and placebo to dexamethasone |
| dexamethasoneAlso: active comparatorTAP block with 4 mg dexamethasone bilaterally | Drug | bupivacaine and dexamethasone |
| placebo to dexamethasoneAlso: PlaceboTAP block with 4 mg placebo to dexamethasone bilaterally | Drug | bupivacaine and placebo to dexamethasone |
Primary outcome
Visual analog score for pain during movement
Time frame: 6 hours post operative
movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain
3 secondary outcomes
Visual analog score during rest
Time frame: 48 hours postoperative
number of patients need Fentanyl consumption
Time frame: 48 hours postoperative
number of days patients stay in hospital
Time frame: 4 weeks
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 5 Aug 2020.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
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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.
hany f sallam, md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bupivacaine and dexamethasone in people with Cesarean Section, run by Aswan University Hospital at 1 site in Egypt.
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 8 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 5 Aug 2020. 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 Egypt. 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?
Visual analog score for pain during movement (time frame: 6 hours post operative). 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 5 Aug 2020.