DexmedetomidinePhase 1NCT07072650
Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in Quadratus Lumborum Block in Patient Undergoing Caesarean Section
A Phase 1 study testing Dexmedetomidine in people with Dexmedetomidine and Quadratus Lumborum Block, run by Majid Fakhir Mutar Alhamaaidah at 1 site in Iraq.
Trial summary
The goal of this clinical trial is to evaluate the effects of adding Dexmedetomidine to local anesthetic agent (bupivacaine) for quadratus lumborum block (QLB) after spinal anesthesia in patient undergoing elective caesarean section. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dexmedetomidine, Quadratus Lumborum Block, Postoperative Analgesia
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 25 Jan 2025to 25 Jun 2025
- Phase
- Phase 1
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age over 18 years' old and less 40 years.
- With body mass indices (BMI) between 18.5 and 34.9 kg/m²
- Pregnancy more than 37 weeks with single fetus.
- Intact membranes.
- Women with a singleton pregnancy.
Who cannot join
- ASA class III or higher,
- contraindications to spinal anesthesia,
- mental or neurological disorders,
- chronic heart, renal, or liver diseases,
- emergency surgery,
- a history of blood coagulation disorders,
- allergies or contraindications to the study drugs,
Trial locations and contacts
1 site in 1 country.
Iraq1 site
Bint Al-Huda Hospital/ thi qar office directorate
Nasiriyah, Thi Qar, 64001
About this study
Official title: Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in QL3 in Patient Undergoing Caesarean Section
The goal of this clinical trial is to evaluate the effects of adding Dexmedetomidine to local anesthetic agent (bupivacaine) for quadratus lumborum block (QLB) after spinal anesthesia in patient undergoing elective caesarean section. The main questions it aims to answer are:
- does adding dexmedetomidine enhance analgesia time?
- does adding dexmedetomidine reduce recovery time?
- does adding dexmedetomidine lower the need of analgesic medication after surgery? Study include 80 female pregnant non-obese patients scheduled for elective caesarean section.
Read the detailed description
Effective postoperative analgesia facilitates a mother's quick recovery, enhances early ambulation, promotes breastfeeding, and reduces the risk of postoperative thromboembolism. The aim of this study was to evaluate the postoperative analgesic efficacy of combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS). A prospective, randomized, blind, controlled trial included 80 female patients aged 18 - 40 years old who underwent cesarean delivery under spinal anesthesia, were randomly assigned to two equal groups. Group dB received a quadratus lumborum block (QLB) with 20 ml of 0.25% bupivacaine and dexmedetomidine (0.5 μg/kg) on each side, while Group B received QLB with 20 ml of 0.25% bupivacaine alone on each side. The primary outcome measured was total analgesic consumption over 24 hours postoperatively. Secondary outcomes included Visual Analog Scale (VAS) scores, time to first analgesic request, and the incidence of side effects such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression.
- Being tested
- Dexmedetomidine
- Keywords
- dexmedetomidine, Quadratus lumborum block, caesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Studying combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS) in elective surgery in Bint Al-Huda Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Group dB | Active comparator | Adding Dexmedetomidine Receives: Drug: Dexmedetomidine |
| Group B | No intervention | Only bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measured was the postoperative pain level score. The Visual Analog Scale (VAS) was used for assessment, where 0 represented no pain and 10 represented the worst pain.
Measured: The first 24 hours postoperatively
Secondary outcomes (6)
The time to the first analgesic request (within the first 24 hours postoperatively )
Measured: over the first 24 hours postoperatively
The total analgesic consumption
Measured: Over the first 24 hours postoperatively
Sedation levels
Sedation levels were also monitored using the Ramsay Sedation Scale which helps assess the patient's level of sedation and consciousness; was used to assess postoperative sedation at 2, 4, 6, 12, and 24 hours postoperatively
Measured: At 2, 4, 6, 12, and 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Measured: Within the first 24 hours
Mean Blood Pressure (MBP)
Measured in mmHg
Measured: Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes
Heart Rate (HR)
Measured as beats/minute
Measured: Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start25 Jan 2025
- Primary completion10 May 2025
- Study completion25 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DexmedetomidineStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Majid Fakhir Mutar Alhamaaidah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Majid Fakhir Mutar Alhamaaidah, Al-Ayen Iraqi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072650
- Sponsor's protocol ID
- 4/2025 in 7/01/2025
- Status last verified
- Jul 2025
- First submitted
- 28 Jun 2025
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adding Dexmedetomidine as an Adjuvant to The Local Anesthetic in QL3 in Patient Undergoing Caesarean Section
- ClinicalTrials.gov ID
- NCT07072650
- Acronym / sponsor ID
- 4/2025 in 7/01/2025
- Keywords
- dexmedetomidine, Quadratus lumborum block, caesarean section
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Majid Fakhir Mutar AlhamaaidahUniversity, hospital or other
- Study start
- 25 Jan 2025 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 25 Jun 2025 (actual)
- First posted
- 18 Jul 2025 (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 goal of this clinical trial is to evaluate the effects of adding Dexmedetomidine to local anesthetic agent (bupivacaine) for quadratus lumborum block (QLB) after spinal anesthesia in patient undergoing elective caesarean section. The main questions it aims to answer are:
- does adding dexmedetomidine enhance analgesia time?
- does adding dexmedetomidine reduce recovery time?
- does adding dexmedetomidine lower the need of analgesic medication after surgery? Study include 80 female pregnant non-obese patients scheduled for elective caesarean section.
Detailed description
Effective postoperative analgesia facilitates a mother's quick recovery, enhances early ambulation, promotes breastfeeding, and reduces the risk of postoperative thromboembolism. The aim of this study was to evaluate the postoperative analgesic efficacy of combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS). A prospective, randomized, blind, controlled trial included 80 female patients aged 18 - 40 years old who underwent cesarean delivery under spinal anesthesia, were randomly assigned to two equal groups. Group dB received a quadratus lumborum block (QLB) with 20 ml of 0.25% bupivacaine and dexmedetomidine (0.5 μg/kg) on each side, while Group B received QLB with 20 ml of 0.25% bupivacaine alone on each side. The primary outcome measured was total analgesic consumption over 24 hours postoperatively. Secondary outcomes included Visual Analog Scale (VAS) scores, time to first analgesic request, and the incidence of side effects such as sedation, nausea, vomiting, shivering, pruritus, bradycardia, hypotension, and respiratory depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group dB | Active comparator | Drug: DexmedetomidineAdding Dexmedetomidine |
| Group B | No intervention | –Only bupivacaine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age over 18 years' old and less 40 years.
- With body mass indices (BMI) between 18.5 and 34.9 kg/m²
- Pregnancy more than 37 weeks with single fetus.
- Intact membranes.
- Women with a singleton pregnancy.
Key exclusion criteria (7 listed)
- ASA class III or higher,
- contraindications to spinal anesthesia,
- mental or neurological disorders,
- chronic heart, renal, or liver diseases,
- emergency surgery,
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 |
|---|---|---|
| DexmedetomidineStudying combining a local anesthetic with dexmedetomidine (DEX) in a quadratus lumborum block (QLB) following a cesarean section (CS) in elective surgery in Bint Al-Huda Hospital. | Drug | Group dB |
Primary outcome
The primary outcome measured was the postoperative pain level score. The Visual Analog Scale (VAS) was used for assessment, where 0 represented no pain and 10 represented the worst pain.
Time frame: The first 24 hours postoperatively
6 secondary outcomes
The time to the first analgesic request (within the first 24 hours postoperatively )
Time frame: over the first 24 hours postoperatively
The total analgesic consumption
Time frame: Over the first 24 hours postoperatively
Sedation levels
Time frame: At 2, 4, 6, 12, and 24 hours postoperatively
Postoperative nausea and vomiting (PONV)
Time frame: Within the first 24 hours
Mean Blood Pressure (MBP)
Time frame: Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes
Heart Rate (HR)
Time frame: Perioperative period at intervals of 0, 5, 10, 20, and 30 minutes
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 2 Oct 2025.
- Individual participant dataSharing planned: Undecided
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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 Phase 1 study testing Dexmedetomidine in people with Dexmedetomidine and Quadratus Lumborum Block, run by Majid Fakhir Mutar Alhamaaidah at 1 site in Iraq.
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 5 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 2 Oct 2025. 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 Iraq. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 primary outcome measured was the postoperative pain level score. The Visual Analog Scale (VAS) was used for assessment, where 0 represented no pain and 10 represented the worst pain. (time frame: The first 24 hours postoperatively). 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 2 Oct 2025.