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CompletedNCT06825286Updated Feb 13, 2025

Dexmedetomidine as an Adjuvant to Bupivacaine in Ultrasound-Guided Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy

An interventional study of Bupivacaine and Bupivacaine and Dexmedetomidinc) group in Dexmedetomidine, Bupivacaine and Ultrasound-Guided, sponsored by Tanta University. Completed at 1 site in Egypt. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Tanta University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Aug 2023, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Dexmedetomidine
  • Bupivacaine
  • Ultrasound-Guided
  • Quadratus Lumborum Block
  • Postoperative Analgesia
  • Laparoscopic Cholecystectomy

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03

In context

Agnosia

1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.

This study's enrollment of 90 is above the median of 78 across 1,024 interventional studies indexed under Agnosia.

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Lead sponsor

Tanta University is the lead sponsor of 963 studies on the registry; 304 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Aged 21-65 years.
  • Both genders.
  • American society of Anesthesiology (ASA) class l, II undergoing elective laparoscopic cholecystectomy

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • Active comparator
    Bupivacaine group

    Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20 ml bupivacaine 0.25%)

    Drug: Bupivacaine

  • Experimental
    Bupivacaine and Dexmedetomidinc group

    Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine I mic/kg)

    Drug: Bupivacaine and Dexmedetomidinc) group

Interventions

  • DrugBupivacaine

    Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block wilh (20 ml bupivacaine 0.25%).

  • DrugBupivacaine and Dexmedetomidinc) group

    Patients received general anesthesia and bilateral ultrasound guided transmuscular quadratus lumborum block with (20ml Bupivacaine 0.25%) + (Dexmedetomidine Imic/kg)

06

What researchers measure

Primary outcomes

  1. Total morphine consumption

    Intravenous morphine 2 mg given when numerical rating scale equal or above 4 as rescue analgesia

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. 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.

    Time frame: At the end of the operation(Up to 48 min).

  2. 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.

    Time frame: At the end of the operation (Up to 48 min).

  3. 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).

    Time frame: lntraoperatively

  4. 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.

    Time frame: 24 hours postoperatively

  5. 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.

    Time frame: 24 hours postoperatively

  6. Incidence of Complication

    Complication such as bradycardia, hypotension, nausea, vomiting, Pruritis, respiratory depression, or any other complication.

    Time frame: 24 hours postoperatively

07

Study locations

1 site
  • Tanta University
    Tanta, ElGharbia 31527, Egypt
08

References and documents

Individual participant data

Plan to share: Yes — The data was available upon a reasonable request from the corresponding author after the end of study for one year.

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06825286
Lead sponsor
Tanta University
Responsible party
Waleed Nagah El said (Resident of Anesthesia, Surgical Intensive Care and Pain Management, Faculty of Medicine,Tanta University, Tanta, Egypt., Tanta University) — Principal investigator
First posted
Feb 13, 2025
Start date
Aug 1, 2023
Primary completion
Aug 1, 2024
Completion
Aug 1, 2024
Last update
Feb 13, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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