DexmedetomidineNCT06825286
Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy
A study testing Bupivacaine and Bupivacaine and Dexmedetomidinc) group in people with Dexmedetomidine and Bupivacaine, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of adding Dexmedctomidinc as adjuvant to Bubivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Dexmedetomidine, Bupivacaine, Ultrasound-Guided
- What is being tested?
- Bupivacaine and Bupivacaine and Dexmedetomidinc) group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 1 Aug 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21-65 years.
- Both genders.
- American society of Anesthesiology (ASA) class l, II undergoing elective laparoscopic cholecystectomy
Who cannot join
- Patient refusal
- History of allergy to local anesthetic.
- Liver or renal pathology affecting drug elimination
- Menta!dysfunction or cognitive disorders.
- Patients on chronic pain medications.
- Body Mass Index > 40 kg/m2.
- Coagulopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
The aim of this study is to evaluate the effect of adding Dexmedctomidinc as adjuvant to Bubivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy.
Read the detailed description
When compared to conventional surgery, laparoscopic cholecystectomy is less invasive and leads to less postoperative pain. However, the postoperative pain following laparoscopic cholecystectomy consists of both somatic and visceral components with pain originating from port entry' wounds, gallbladder resection and abdominal insufflation that leads to peritoneal distention and peritoneal damage.
Quadratus lamborum block (QLB) is abdominal truncal block that provides both somatic and visceral analgesia for both upper and lower abdominal surgical procedures, It was first introduced by Blanco.Currently There are 4 approaches described for QLB: lateral, posterior, anterior and intramuscular. Transmuscular (anterior) QLB Type 3 block involves injection in the plane between the psoas major (PM) and the QL muscles studies have reported spread of the injectate to the thoracic paravertebral space, as well as the spinal nerve which runs anterior to the QL muscle
- Conditions
- Dexmedetomidine, Bupivacaine, Ultrasound-Guided, Quadratus Lumborum Block, Postoperative Analgesia, Laparoscopic Cholecystectomy
- Being tested
- Bupivacaine, Bupivacaine and Dexmedetomidinc) group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block wilh (20 ml bupivacaine 0.25%).
Bupivacaine and Dexmedetomidinc) groupDrug
Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine Imic/kg)
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine group | Active comparator | Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20 ml bupivacaine 0.25%) Receives: Drug: Bupivacaine |
| Bupivacaine and Dexmedetomidinc group | Experimental | Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine I mic/kg) Receives: Drug: Bupivacaine and Dexmedetomidinc) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Intravenous morphine 2 mg given when numerical rating scale equal or above 4 as rescue analgesia
Measured: 24 hours postoperatively
Secondary outcomes (6)
Mean arterial blood pressure
Mean arterial blood pressure was recorded before the block (base-line value), after skin incision by 5,15,30 minutes, and at the end of the operation.
Measured: At the end of the operation(Up to 48 min).
Heart rate
Heart rate was recorded before the block (base-line value), after skin incision by 5,15,30 minutes, and at the end of the operation.
Measured: At the end of the operation (Up to 48 min).
lntraoperative fentanyl consumption
Additional fentanyl dosages of 0.5 µg/kg IV was administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline (after exclusion of other causes than pain).
Measured: lntraoperatively
Degree of pain score
Postoperative pain was assessed by the numerical rating scale (NRS; 0 no pain while 10 is the maximum pain) immediately after discharge to the PACU and ward at 6, 12, 18, 24 hours.
Measured: 24 hours postoperatively
Time to the first request for the rescue analgesia
Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated).IV morphine 2mg was given when NRS equal or above 4.
Measured: 24 hours postoperatively
Incidence of Complication
Complication such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start1 Aug 2023
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
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.
- More trials run by Tanta 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed Nagah El said, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825286
- Sponsor's protocol ID
- 36264MS296/8/23
- Status last verified
- Feb 2025
- First submitted
- 8 Feb 2025
- Last updated
- 13 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data was available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06825286
- Acronym / sponsor ID
- 36264MS296/8/23
- Conditions
- Dexmedetomidine, Bupivacaine, Ultrasound-Guided, Quadratus Lumborum Block, Postoperative Analgesia, Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 13 Feb 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 aim of this study is to evaluate the effect of adding Dexmedctomidinc as adjuvant to Bubivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy.
Detailed description
When compared to conventional surgery, laparoscopic cholecystectomy is less invasive and leads to less postoperative pain. However, the postoperative pain following laparoscopic cholecystectomy consists of both somatic and visceral components with pain originating from port entry' wounds, gallbladder resection and abdominal insufflation that leads to peritoneal distention and peritoneal damage.
Quadratus lamborum block (QLB) is abdominal truncal block that provides both somatic and visceral analgesia for both upper and lower abdominal surgical procedures, It was first introduced by Blanco.Currently There are 4 approaches described for QLB: lateral, posterior, anterior and intramuscular. Transmuscular (anterior) QLB Type 3 block involves injection in the plane between the psoas major (PM) and the QL muscles studies have reported spread of the injectate to the thoracic paravertebral space, as well as the spinal nerve which runs anterior to the QL muscle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine group | Active comparator | Drug: BupivacainePatients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20 ml bupivacaine 0.25%) |
| Bupivacaine and Dexmedetomidinc group | Experimental | Drug: Bupivacaine and Dexmedetomidinc) groupPatients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine I mic/kg) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 21-65 years.
- Both genders.
- American society of Anesthesiology (ASA) class l, II undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (7 listed)
- Patient refusal
- History of allergy to local anesthetic.
- Liver or renal pathology affecting drug elimination
- Menta!dysfunction or cognitive disorders.
- Patients on chronic pain medications.
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 |
|---|---|---|
| BupivacainePatients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block wilh (20 ml bupivacaine 0.25%). | Drug | Bupivacaine group |
| Bupivacaine and Dexmedetomidinc) groupPatients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine Imic/kg) | Drug | Bupivacaine and Dexmedetomidinc group |
Primary outcome
Total morphine consumption
Time frame: 24 hours postoperatively
Intravenous morphine 2 mg given when numerical rating scale equal or above 4 as rescue analgesia
6 secondary outcomes
Mean arterial blood pressure
Time frame: At the end of the operation(Up to 48 min).
Heart rate
Time frame: At the end of the operation (Up to 48 min).
lntraoperative fentanyl consumption
Time frame: lntraoperatively
Degree of pain score
Time frame: 24 hours postoperatively
Time to the first request for the rescue analgesia
Time frame: 24 hours postoperatively
Incidence of Complication
Time frame: 24 hours postoperatively
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 13 Feb 2025.
- Individual participant dataSharing planned: Yes. The data was available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Bupivacaine and Bupivacaine and Dexmedetomidinc) group in people with Dexmedetomidine and Bupivacaine, run by Tanta 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 3 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 13 Feb 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 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?
Total morphine consumption (time frame: 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 13 Feb 2025.