ClinicalTrials.gg
Sign In
CompletedNCT06229054Updated Aug 12, 2024

Dexmedetomidine in Obturator Nerve Block as an Analgesic in Transurethral Surgeries

An Early Phase 1 interventional study of Dexmedetomidine and Bupivacaine Hydrochloride in Dexmedetomidine, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Cairo University · Early Phase 1, Interventional, and Prevention

Phase
Early Phase 1
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

in our study, we will investigate the impact of adding dexmedetomidine to bupivacaine for the potency of the obturator nerve block and prevention of the postoperative pain associated with transurethral surgery in comparison of obturator nerve block with bupivacaine alone

Read the detailed description
  • After history taking and examination of the labs and airway of the patient , An intravenous catheter will be secured in the dorsum of the hand of non dominant hand and patients will be monitored for heart rate, noninvasive blood pressure, and oxygen saturation.
  • All patients after aseptic preparation will receive subarachnoid block in lumber 3-4 or 4-5 space in sitting position.
  • About 3 ml (15mg) of heavy 0.5% bupivacaine will be injected into subarachnoid space.
  • After the completion of the block, patients will be laid in the supine position and subsequently waited for 5 min for fixation of drug and assessed for sensorimotor block.
  • Further procedure will be performed as per the group allocation.
  • ONB will be performed by classic technique 1.5cm lateral and 1.5cm caudal to the pubic tuberacle . after contact with the pubic ramus is made , the needle is redirected laterally to a point 2-3 cm deeper than the pubic ramus.(15)
  • A waiting period 20 min will be allowed for the full effect of the block and then resection will be allowed to perform
  • Hemodynamics (heart rate, mean arterial blood pressure) will be recorded intraoperatively and postoperative at 0, 2 and 6 hours .
  • VAS score at 0,2 and 6 hours post-operatively will be assessed.
  • Time to first call for analgesic requirements (duration of analgesia) will be measured.
  • Total postoperative analgesic consumption in the first 24 hours post-operative will be measured.
  • Incidence of complications such as nerve injury, hematoma formation, local anesthetic toxicity, intravascular injection, bleeding and bladder perforation will be assessed.
02

Conditions studied

  • Dexmedetomidine

Keywords

  • obturator nerve block
  • Dexmedetomidine
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants will be adults (above 18 years) scheduled to undergo transurethral surgery under regional anesthesia.
  • ASA1, ASA2

Exclusion criteria

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical class 3,4, severe cardiac comorbidity (impaired contractility with ejection fraction less than 50%, heart block, significant arrhythmias, tight valvular lesions), allergy to any study's drugs
05

Study design

Phase
Early Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    group Dexmedetomidine

    : Patients in this group will receive regional anesthesia and obturator nerve block bilaterally (10 ml 2% preservative-free lignocaine along with 5 ml 0.5% preservative-free bupivacaine) and dexmedetomidine 100 mcg/mL (2µg/kg).

    Drug: Dexmedetomidine · Drug: Bupivacaine Hydrochloride

  • Other
    group Bupivacaine

    :Patients in this group will receive regional anesthesia and bilateral obturator nerve block only (10 ml 2% preservative-free lignocaine along with 5 ml 0.5% preservative-free bupivacaine).

    Drug: Bupivacaine Hydrochloride

Interventions

  • DrugDexmedetomidine

    Dexmedetomidine (DEX), an α2-agonist with more promising pharmacokinetic and pharmacodynamic characteristics than clonidine has been proved to have a positive effect on postoperative pain intensity and to reduce opioid consumption

    Also known as: DEX

  • DrugBupivacaine Hydrochloride

    local anesthesic which works through blocking sodium channels

    Also known as: marcaine

06

What researchers measure

Primary outcomes

  1. Severity of pain measured by visual analog scale (VAS) score. postoperative pain after transurethral surgeries

    the VAS score consists of 10cm line where 0 represents NO PAIN and 10 represents SEVEREST FORM OF PAIN

    Time frame: 24 hours postoperatively

Secondary outcomes

  1. • Perioperative analgesic consumption, which will be calculated as the total amount of opioids administered in the postoperative periods.

    to detect incidence of pain postoperative

    Time frame: 24 hours postoperative

  2. • Incidence of adverse effects as bleeding and bladder perforation.

    to detect any complications occured during the surgery

    Time frame: 24 hours postoperative

  3. • Incidence of adductor jerk reflex

    to detect incidience of jerk reflex during the surgery

    Time frame: intraoperative

07

Study locations

1 site
  • Faculty of Medicine-Cairo Univeristy
    Cairo, 11562, Egypt
08

References and documents

Publications

  • Badrinath R., Konety MD, MBA, Peter R., Carroll MD: Urothelial carcinoma in Smith's General Urology, edited by Emil A. Tanagho, Jack W., and MC Ninch (Eds.), 17th edition, MC Graw Hil, 2008.
  • Peter T. Nich, MD; Fray F. Marshall, MD Surgery for bladder cancer. Walsh, Patrick C., Retik, Alan B., E. Darracott Vaughan, and Alan J. Wein [Eds]: Campbell's Urology, 9th ed. Philadelphia: Saunders, 2007. 2478
  • Erbay G, Akyol F, Karabakan M, Celebi B, Keskin E, Hirik E. Effect of obturator nerve block during transurethral resection of lateral bladder wall tumors on the presence of detrusor muscle in tumor specimens and recurrence of the disease. Kaohsiung J Med Sci. 2017 Feb;33(2):86-90. doi: 10.1016/j.kjms.2016.11.006. Epub 2016 Dec 30. PubMed 28137416 ↗
  • Bilotta F, Pugliese F. The evolving clinical use of dexmedetomidine. Lancet. 2020 Jul 18;396(10245):145-147. doi: 10.1016/S0140-6736(20)30902-8. No abstract available. PubMed 32682463 ↗
  • Abdulatif M, Mukhtar A, Obayah G. Pitfalls in reporting sample size calculation in randomized controlled trials published in leading anaesthesia journals: a systematic review. Br J Anaesth. 2015 Nov;115(5):699-707. doi: 10.1093/bja/aev166. Epub 2015 Jun 3. PubMed 26041717 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2024 to primary completion in Jul 2024, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2024
First posted
Jan 29, 2024
StartActual
Feb 1, 2024
Primary completionActual
Jul 20, 2024
CompletionActual
Aug 1, 2024
Last update
Aug 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06229054
Lead sponsor
Cairo University
Responsible party
Karim Hussein (lecturer, Cairo University) — Principal investigator
First posted
Jan 29, 2024
Start date
Feb 1, 2024
Primary completion
Jul 20, 2024
Completion
Aug 1, 2024
Last update
Aug 12, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Dexmedetomidine

Other studies from this sponsor

Cairo University →

Start the discussion