AnalgesiaTAP_dexmedetNCT05342844
Different Doses of Dexmedetomidine Added to Bupivacaine in Transversus Abdominis Plane Block in Caesarean Delivery
A study testing Dexmedetomidine 0.5 mcg and Dexmedetomidine 1 mcg in people with Analgesia, run by Mansoura University at 1 site in Egypt.
Trial summary
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Analgesia
- What is being tested?
- Dexmedetomidine 0.5 mcg and Dexmedetomidine 1 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 14 Jun 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age from 19 to 40 years old
- American Society of Anesthesiologists (ASA) physical status II patients
- Singleton pregnancies with a gestational age of at least 37 weeks.
- Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.
Who cannot join
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Inability to comprehend or participate in the pain scoring system.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Hypersensitivity to any drug used in the study.
- Any hypertensive disorders of pregnancy.
Show all 9Show fewer
- Renal impairment or other contraindications to non-steroidal anti-infilamatory drugs (NSAIDS).
- Significant cardiovascular, renal or hepatic abnormalities.
- Patients with history of opioid intake, drug abusers or psychiatric patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Two Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Caesarean Delivery
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.
Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties
Read the detailed description
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia
- Conditions
- Analgesia
- Being tested
- Dexmedetomidine 0.5 mcg, Dexmedetomidine 1 mcg
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 0.5 mcgDrug
0.5 mcg/kg
Dexmedetomidine 1 mcgDrug
1 mcg/kg
| Study group | Role | What they receive |
|---|---|---|
| Group-Control | No intervention | After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline 0.9% for each side |
| Group-Dexmedetomidine 0.5 | Active comparator | After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline containing 0.5 mcg/kg dexmedetomidine for each side Receives: Drug: Dexmedetomidine 0.5 mcg |
| Group-Dexmedetomidine1 | Active comparator | After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0. 5% plus 10 mL normal saline containing 1 mcg/kg dexmedetomidine for each side Receives: Drug: Dexmedetomidine 1 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time of the first postoperative analgesic requirement
Measured: during the first 24 postoperative hours
Secondary outcomes (9)
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the
mg
Measured: during the first 24 postoperative hours
The visual analog scale (VAS) scores during rest
11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
Measured: during the first 24 postoperative hours
The visual analog scale (VAS) scores during movement
11-point VAS (where 0 for no pain and 10 for the worst possible pain) at 0, 2, 4,6,12 and 24 hours postoperatively
Measured: during the first 24 postoperative hours
Mean arterial blood pressure (MBP)
mmHg
Measured: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
heart rate (HR)
beat per minute
Measured: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Patient satisfaction about the quality of postoperative analgesia
poor = 1, fair = 2, good = 3, excellent = 4
Measured: during the first 24 postoperative hours
The side effects (nausea, vomiting, abdominal colic and lower limb weakness)
incidence
Measured: during the first 24 postoperative hours
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome
Measured: during the first 24 postoperative hours
The level of sedation
using a 4-point scale (0 = awake and alert, 1 = minimally sedated, responds to speech, 2 = moderately sedated, arousable by tactile stimulation, and 3 = deeply sedated, arousable only by painful stimulation)
Measured: during the first 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 May 2022
- Primary completion31 Dec 2022
- Study completion14 Jun 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 Mansoura 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
- according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into three groups; Group-Control, Group-Dexmedetomidine 0.5 and Group-Dexmedetomidine 1 according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342844
- Sponsor's protocol ID
- TAP-dexmedetomidine
- Acronym
- TAP_dexmedet
- Status last verified
- Jun 2023
- First submitted
- 11 Apr 2022
- Last updated
- 23 Jun 2023
- 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 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Different Doses of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Caesarean Delivery
- ClinicalTrials.gov ID
- NCT05342844
- Acronym / sponsor ID
- TAP_dexmedet / TAP-dexmedetomidine
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 25 Apr 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.
Cesarean birth is a common surgical procedure. After cesarean birth, postsurgical pain may delay recovery, interfere with maternal-newborn bonding, and reduce the breastfeeding if not adequately controlled. Postpartum analgesia has become a common concern.
Many adjuvant drugs used for peripheral nerve blocks as( N-methyl-d-aspartate (NMDA) receptor antagonists , Magnesium , Ephedrine , Dexamesathone , Fentanyl , Midazolam and Neostigmine) Dexmedetomidine is a potent and highly selective α2 adrenergic receptor agonist, exerts its sympatholytic effect by inhibiting the release of noradrenaline from central and peripheral sympathetic nerve endings. It is considered to be a useful agent with a wide safety margin, excellent sedative capacity and moderate analgesic properties
Detailed description
This prospective double-blinded randomized controlled study will be done on parturients that are scheduled for elective cesarean delivery under spinal anesthesia to assess the efficacy of two different doses (0.5 mcg/kg and 1mcg/kg) of dexmedetomidine as an adjuvant to isobaric bupivacaine in TAPB compared to a control group on the postoperative analgesia in cesarean section under spinal anaesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- according to the computer-generated random number codes that will be placed in sealed envelopes, the patients will be randomly allocated into three groups; Group-Control, Group-Dexmedetomidine 0.5 and Group-Dexmedetomidine 1 according tho the local anesthetic injected in Ultrasound-guided bilateral Tranversus abdominis plane block
| Arm | Type | Receives |
|---|---|---|
| Group-Control | No intervention | –After cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline 0.9% for each side |
| Group-Dexmedetomidine 0.5 | Active comparator | Drug: Dexmedetomidine 0.5 mcgAfter cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0.5% plus 10 mL normal saline containing 0.5 mcg/kg dexmedetomidine for each side |
| Group-Dexmedetomidine1 | Active comparator | Drug: Dexmedetomidine 1 mcgAfter cession section, patients Will receive ultrasound (US)-guided bilateral transversus abdominis plane block with 10 mL bupivacaine 0. 5% plus 10 mL normal saline containing 1 mcg/kg dexmedetomidine for each side |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age from 19 to 40 years old
- American Society of Anesthesiologists (ASA) physical status II patients
- Singleton pregnancies with a gestational age of at least 37 weeks.
- Patients undergoing spinal anesthesia for cesarean delivery via a Pfannenstiel incision with exteriorization of the uterus.
Key exclusion criteria (9 listed)
- Age < 19 or > 40 years.
- Height<150 cm, weight < 60 kg, body mass index (BMI) ≥40 kg/m2.
- Inability to comprehend or participate in the pain scoring system.
- Contraindications to spinal anesthesia (Coagulopathy, increased intracranial pressure, or local skin infection).
- Hypersensitivity to any drug used in the study.
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 |
|---|---|---|
| Dexmedetomidine 0.5 mcg0.5 mcg/kg | Drug | Group-Dexmedetomidine 0.5 |
| Dexmedetomidine 1 mcg1 mcg/kg | Drug | Group-Dexmedetomidine1 |
Primary outcome
The time of the first postoperative analgesic requirement
Time frame: during the first 24 postoperative hours
9 secondary outcomes
Total amount of the postoperative analgesic drugs (ketolac, paracetamol and fentanyl) consumed in the
Time frame: during the first 24 postoperative hours
The visual analog scale (VAS) scores during rest
Time frame: during the first 24 postoperative hours
The visual analog scale (VAS) scores during movement
Time frame: during the first 24 postoperative hours
Mean arterial blood pressure (MBP)
Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
heart rate (HR)
Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Patient satisfaction about the quality of postoperative analgesia
Time frame: during the first 24 postoperative hours
The side effects (nausea, vomiting, abdominal colic and lower limb weakness)
Time frame: during the first 24 postoperative hours
the time from intrathecal injection till regression of spinal anesthesia to L2 dermatome
Time frame: during the first 24 postoperative hours
The level of sedation
Time frame: during the first 24 postoperative hours
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 23 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine 0.5 mcg and Dexmedetomidine 1 mcg in people with Analgesia, run by Mansoura 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 4 inclusion and 9 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 23 Jun 2023. 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?
The time of the first postoperative analgesic requirement (time frame: during the first 24 postoperative 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 23 Jun 2023; AzTrials last refreshed its copy on 8 Nov 2026.