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To Compare Efficacy of Dexmedetomidine in Bilateral Quadratus Lumborum vs Lumbar Epidural Blocks on Analgesia After Major Lower Abdominal SurgeryNCT06130670

Clinical Efficacy and Safety of Dexmedetomidine as an Adjuvant in Quadratus Lumborum Versus Epidural Block in Postoperative Lower Abdominal Cancer Surgeries

A study testing nerve block in people with To Compare Efficacy of Dexmedetomidine in Bilateral Quadratus Lumborum vs Lumbar Epidural Blocks on Analgesia After Major Lower Abdominal Surgery, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Clinical efficacy and safety of dexmedetomidine as an adjuvant in quadratus lumborum versus epidural block in postoperative patients Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
What is being tested?
nerve block
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteEgypt
Study dates
20 Apr 2024to 31 Dec 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 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • patient's 18-70years old
  • ASA I-II and NYHA I-II.
  • type of surgery: major lower abdominal cancer surgery

Who cannot join

  • Patients who refused to participate in the study.
  • coagulation disorders.
  • opioid dependence.
  • sepsis or local infection at or near the vicinity of the block site.
  • patients with psychiatric illnesses that would interfere with perception and assessment of pain.
  • allergy to any of the studied drugs.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Assiut University

    Asyut

Other trials in Egypt

About this study

Official title: Clinical Efficacy and Safety of Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-guided Quadratus Lumborum Versus Epidural Block for Postoperative Analgesia in Lower Abdominal Cancer Surgeries.

Clinical efficacy and safety of dexmedetomidine as an adjuvant in quadratus lumborum versus epidural block in postoperative patients

Read the detailed description

One of the main concerns of patients presenting for major abdominal surgery and anesthesiologists who are involved in postoperative care is postoperative analgesia[1].

Despite improvements in surgical technique and perioperative care, complications in the immediate post-operative period remain significant [2]. The patients often experience significant post-operative pain and functional impairment and need 5-10 days to recover [3], [4].

Poor postoperative pain control leads to longer postoperative care, longer hospital stay and decreased patient overall satisfaction [5]. Opioids remain the mainstay of postoperative pain relief but have their own side effects. Therefore, the use of a multimodal analgesic strategy is nowadays preferable in most clinical settings to minimize the need for opioids. The use of regional anesthetic techniques provides excellent analgesia, as their effect can extend beyond the perioperative period [6].

As an important element of multimodal analgesia, regional blocks can reduce the dosage of opioids, minimize side effects, and enhance the quality of recovery after surgery [7].

Ultrasound-guided Quadratus Lumborum Block (QLB) is a relatively new regional anesthetic technique that was first described by Professor R. Blanco in 2007 at the annual scientific meeting of the European Society of Regional Anesthesia [8], it is relatively easily performed, the block effect lasts 24 - 48 h and up till now, no complications have been described during or after the block performance. QLB is safe and has found its place in multimodal postoperative pain strategy in patients undergoing abdominal surgery [9]. Quadratus lumborum block (QLB) is an emerging truncal block technique, [10] which includes injecting local anesthetic (LA) into the thoracolumbar fascia (TLF) surrounding the quadratus lumborum (QL) muscle. The analgesic effect is produced by the LA spreading along the TLF into the thoracic paravertebral space and transversalis fascia. QLB is an effective analgesic method for patients undergoing abdominal and hip surgeries [11,12 ,13 ,14]. Based on the different injection sites, there are four types of QLB, namely, lateral QLB, posterior QLB, transmuscular QLB, and intramuscular QLB. Transmuscular QLB includes the injection of LA between the QL muscle and the psoas major (PM) muscle. Transmuscular QLB can be implemented at the L4 and L2 levels using the subcostal approach [15]. Hesham et al. [16] have reported that the use of the subcostal approach to Transmuscular QLB can provide appropriate sensory blockade for open urological surgeries.

Epidural anesthesia is a technique for perioperative pain management with multiple applications in anesthesiology. It is useful as a primary anesthetic, but most commonly, it is used as a pain management adjuvant. It can be a single shot or a continuous infusion for long-term pain relief. Aside from the benefit of potentially providing excellent analgesia, its use reduces the exposure to other anesthetics and analgesics, decreasing side effects. It has also shown to decrease cortisol levels, expedite the return of bowel function, decrease the incidence of PE and DVT in the postoperative period, and shorten lengths of in-hospital stay.[17][18][19]

Regarding major lower abdominal surgery, epidural analgesia was shown to be the gold standard time-tested technique for providing postoperative analgesia, but due to its possible complications, contraindications, there is a need for other equally efficient analgesic techniques [20].

Adjuvant to local anesthetics is an evolving and exciting field of anesthesia practice with new technology promising to improve patient satisfaction and safety. While opioids continue to be the most commonly used local anesthetic adjuvant in clinical practice, alpha-2 receptor antagonists, especially dexmedetomidine, has been shown to potentiate the effect of local anaesthetics with an acceptable safety profile. Use of adjuvants to local anesthetic should take into consideration the available evidence and the advocated safe dose ranges, its effective routes of administration, the adverse effect profile of use of such adjuncts as well as preparedness to manage life threatening complications such as Local Anesthesia Systemic Toxicity (LAST). Its users should be aware of its neurotoxicity potential following perineural use and watch for its clinical implications. Search for newer molecules and techniques allowing for lesser perineural doses of local anesthetic, enhanced analgesic effect and improved safety profile are expected to guide further studies in future to fill up the present lacuna in evidence about the use of adjuvant for local anaesthetics.(21)

There are many adjuvants to local anesthesia that has been used in QLB and epidural analgesia such as: magnesium sulfate ,opioids ,dexamethasone,dexmedetomidine,etc.

The advantages of dexmedetomidine include reductions in cognitive dysfunction [22], respiratory depression [23, 24], ICU stays [25, 26], and financial costs [27]. Furthermore, it appears that dexmedetomidine can act synergistically when used in conjunction with other analgesic or anesthetic medications and can reduce their side effects [28-30]. However, it has been suggested that dexmedetomidine reduces both heart rate [31] and blood pressure [24].

The addition of dexmedetomidine to other anesthetic agents during epidural procedures provided a longer duration of analgesia, as well as highly significant improvements in the time to sensory block and the sedation score, and decreased the requirement for rescue analgesia.(32) Interfascial dexmedetomidine adjuvant to QLB provided better postoperative analgesia in terms of less morphine consumption, better pain scores and longer time to first analgesic request when compared with the IV dexmedetomidine.(33) In this study we will compare the effect of dexmedetomidine in bilateral quadratus lumborum block and lumbar epidural block on postoperative analgesia.

Aim(s) of the Research :

Comparing the efficacy of Dexmedetomidine in bilateral quadratus lumborum block versus lumbar epidural block on postoperative analgesia following major lower abdominal cancer surgery.

Being tested
nerve block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • nerve blockOther

    Comparing the efficacy of Dexmedetomidine in bilateral quadratus lumborum block versus lumbar epidural block on postoperative analgesia following major lower abdominal cancer surgery.

Study groups in NCT06130670
Study groupRoleWhat they receive
Group1:Ultrasound-guided quadratus lumborum block techniqueOtherUltrasound-guided quadratus lumborum block technique: the patients were placed in the lateral position. Following disinfecting of the site of injection, a convex probe (2-5 HZ, Edge, Sonosite, Seattle, the USA) was positioned in a parasagittal oblique plane at the L3-L4 level, which is approximately 4 cm from the posterior midline. The iliac crest, erector spinae (ES) muscle, QL muscle, and psoas (PM) muscle were identified, and a an 18-gauge Touhy's epidural needle (BBRAUN epidural set) was directed to the anterior part of the QL. Then, the needle tip was located between the QL and PM using the in-plane technique. Normal saline 5 mL was used to identify the plane. After confirmation of the injection site, 20 ml of 0.25% Bupivacaine bolus was injected and 1 μg/kg of dexmedetomidine dissolved in 2 ml normal saline were injected also between the QL and PM muscles divided equally on each side of the abdominal wall before induction general anesthesia.
Receives: Other: nerve block
Group2:Lumbar epidural blockOtherLumbar epidural block: Under strict aseptic precautions, lumbar epidural was performed for patients in Group II using a 16-gauge Touhy epidural needle by a median approach. The L3 - L4 interspaces was chosen for the injection. The epidural space identified by the loss of resistance technique. The catheter was advanced 4 cm cephalad. When the aspiration test results for blood and cerebrospinal fluid were negative, a test dose of (3 mL) 2% lidocaine was given after the placement of the epidural catheter. In the epidural catheter a bolus dose of 15 ml bupivacaine 0.25% and 1 μg/kg of dexmedetomidine dissolved in 2 ml normal saline was injected before induction of general anesthesia.
Receives: Other: nerve block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. postoperative analgesia

    Time of first analgesic request during the first 24 hrs after surgery.

    Measured: the first 24 hrs after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2023
  2. Study start20 Apr 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Comparing the efficacy of Dexmedetomidine in bilateral quadratus lumborum block versus lumbar epidural block on postoperative analgesia following major lower abdominal cancer surgery
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06130670
Sponsor's protocol ID
dexmedetomidine as an adjuvant
Status last verified
Nov 2025
First submitted
5 Nov 2023
Last updated
1 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu W, Daneshmand S, Bazargani ST, Cai J, Miranda G, Schuckman AK, Djaladat H. Postoperative Pain Management after Radical Cystectomy: Comparing Traditional versus Enhanced Recovery Protocol Pathway. J Urol. 2015 Nov;194(5):1209-13. doi: 10.1016/j.juro.2015.05.083. Epub 2015 Aug 13.

    PubMed 26021824
  • Patel HD, Ball MW, Cohen JE, Kates M, Pierorazio PM, Allaf ME. Morbidity of urologic surgical procedures: an analysis of rates, risk factors, and outcomes. Urology. 2015 Mar;85(3):552-9. doi: 10.1016/j.urology.2014.11.034.

    PubMed 25733265
  • Bhalla RG, Wang L, Chang SS, Tyson MD. Association between Preoperative Albumin Levels and Length of Stay after Radical Cystectomy. J Urol. 2017 Nov;198(5):1039-1045. doi: 10.1016/j.juro.2017.05.066. Epub 2017 May 19.

    PubMed 28533006

Questions about this trial

What is this clinical trial studying?

A study testing nerve block in people with To Compare Efficacy of Dexmedetomidine in Bilateral Quadratus Lumborum vs Lumbar Epidural Blocks on Analgesia After Major Lower Abdominal Surgery, run by Assiut 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 6 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 1 Dec 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?

postoperative analgesia (time frame: the first 24 hrs after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06130670, which also lists 3 linked publications.

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 1 Dec 2025.

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