Post Operative PainNCT06292273
Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block in Caesarean Section
A study testing Transversus Abdominis Plane Block with bupivacain Plus dexamethasone and Transversus Abdominis Plane Block with bupivacain in people with Post Operative Pain, run by Menoufia University at 1 site in Egypt.
Trial summary
Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic… 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
- Post Operative Pain
- What is being tested?
- Transversus Abdominis Plane Block with bupivacain Plus dexamethasone and Transversus Abdominis Plane Block with bupivacain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2023to 20 Feb 2024
- 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
- pregnant female elected for cesarean section
- ASAll
Who cannot join
- coagulopathy
- BMI>35
- heart Diseases
- diabets
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block for Post-operative Analgesia in Patients Undergoing Caesarean Section: A Comparative Study.
Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries. this study is conducted to analyse the effect of addition of dexmedetomidine to bupivacaine in Transversus Abdominis Plane (TAP) block.
Read the detailed description
Peripheral nerve block is becoming increasingly popular technique for postoperative pain relief and is also established as a part of multimodal analgesia and enhanced recovery program. Transversus abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries.The Purpose of a TAP block is to infiltrate local anaesthetic agents in the plane between the internal oblique and transversus abdominis muscles thereby providing effective postoperative analgesia. Earlier the blind TAP block (through lumbar triangle of Petit) was commonly given but with widespread use of ultrasound nowadays it is almost always given under ultrasound guidance. Accuracy and efficacy of TAP block is significantly improved under ultrasound guidance because under ultrasound guidance the anesthetic agent can be properly deposited in the neurovascular plane. Ultrasound provides real time and direct visualisation of needle during infiltration of local anaesthetic drug.
- Conditions
- Post Operative Pain
- Being tested
- Transversus Abdominis Plane Block with bupivacain Plus dexamethasone, Transversus Abdominis Plane Block with bupivacain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversus Abdominis Plane Block with bupivacain Plus dexamethasoneProcedure or surgery
Bupivacain 0.1%, 35 ml with dexmedetomidine 0.5 µG/kg on each side
Transversus Abdominis Plane Block with bupivacainProcedure or surgery
plain bupivacaine 0.25%, 25 ml bilaterally
| Study group | Role | What they receive |
|---|---|---|
| Group Bupivacain Plus dexamethasone | Active comparator | receiving plain bupivacaine 0.1%, 35 ml with dexmedetomidine 0.5 Receives: Procedure: Transversus Abdominis Plane Block with bupivacain Plus dexamethasone |
| Group bupivacain | Placebo comparator | plain bupivacaine 0.25%, 25 ml bilaterally Receives: Procedure: Transversus Abdominis Plane Block with bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post operative pain
visual analog score from 0 to 10 where 0 is no pain and 10 worst pain ever
Measured: 24 hours
Secondary outcomes (4)
Sedation
Modefied Ramsey sedation score from 1 to 6
Measured: 24 hours
Heart rate
pulse/ min
Measured: 24 hours
Total analgesic consumption
Mg
Measured: 24 hours
Side effects
Nausea, vomiting, pruritus
Measured: 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start10 Oct 2023
- Primary completion1 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Menoufia 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double blind case control
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rabab Mohammad habeeb, Menoufia University
- Investigators
- rabab M habeeb, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292273
- Sponsor's protocol ID
- ANET19
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block for Post-operative Analgesia in Patients Undergoing Caesarean Section: A Comparative Study.
- ClinicalTrials.gov ID
- NCT06292273
- Acronym / sponsor ID
- ANET19
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 5 Mar 2024 (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.
Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries. this study is conducted to analyse the effect of addition of dexmedetomidine to bupivacaine in Transversus Abdominis Plane (TAP) block.
Detailed description
Peripheral nerve block is becoming increasingly popular technique for postoperative pain relief and is also established as a part of multimodal analgesia and enhanced recovery program. Transversus abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries.The Purpose of a TAP block is to infiltrate local anaesthetic agents in the plane between the internal oblique and transversus abdominis muscles thereby providing effective postoperative analgesia. Earlier the blind TAP block (through lumbar triangle of Petit) was commonly given but with widespread use of ultrasound nowadays it is almost always given under ultrasound guidance. Accuracy and efficacy of TAP block is significantly improved under ultrasound guidance because under ultrasound guidance the anesthetic agent can be properly deposited in the neurovascular plane. Ultrasound provides real time and direct visualisation of needle during infiltration of local anaesthetic drug.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, double blind case control
| Arm | Type | Receives |
|---|---|---|
| Group Bupivacain Plus dexamethasone | Active comparator | Procedure: Transversus Abdominis Plane Block with bupivacain Plus dexamethasonereceiving plain bupivacaine 0.1%, 35 ml with dexmedetomidine 0.5 |
| Group bupivacain | Placebo comparator | Procedure: Transversus Abdominis Plane Block with bupivacainplain bupivacaine 0.25%, 25 ml bilaterally |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant female elected for cesarean section
- ASAll
Key exclusion criteria (4 listed)
- coagulopathy
- BMI>35
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 |
|---|---|---|
| Transversus Abdominis Plane Block with bupivacain Plus dexamethasoneBupivacain 0.1%, 35 ml with dexmedetomidine 0.5 µG/kg on each side | Procedure or surgery | Group Bupivacain Plus dexamethasone |
| Transversus Abdominis Plane Block with bupivacainplain bupivacaine 0.25%, 25 ml bilaterally | Procedure or surgery | Group bupivacain |
Primary outcome
Post operative pain
Time frame: 24 hours
visual analog score from 0 to 10 where 0 is no pain and 10 worst pain ever
4 secondary outcomes
Sedation
Time frame: 24 hours
Heart rate
Time frame: 24 hours
Total analgesic consumption
Time frame: 24 hours
Side effects
Time frame: 24hours
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 Mar 2024.
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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.
rabab M habeeb principal investigator
Menoufia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversus Abdominis Plane Block with bupivacain Plus dexamethasone and Transversus Abdominis Plane Block with bupivacain in people with Post Operative Pain, run by Menoufia University 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 2 inclusion and 4 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 Mar 2024. 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. 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?
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?
Post operative pain (time frame: 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 5 Mar 2024.