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Perioperative AnalgesiaPhase 3NCT07573969

Adding Dexmedetomidine Versus Ketamine to Bupivacaine in Fluoroscopy Guided Caudal Analgesia for Lumbosacral Surgeries

A Phase 3 study testing Group C (plain bupivacaine (0.125%)), Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine) and Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine) in people with Perioperative Analgesia, run by Ain Shams University at 1 site in Egypt.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the effect of adding dexmedetomidine to bupivacaine compared to ketamine in the caudal block on perioperative analgesia in patients undergoing lumbosacral surgeries under general anesthesia. Read more about this study

Who is it for?
Ages 21 to 60 years
Conditions the study is for
Perioperative Analgesia
What is being tested?
Group C (plain bupivacaine (0.125%)), Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine) and Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteEgypt
Study dates
May 2026to May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age 21-60 years.
  • Sex: Both sexes.
  • American Society of Anesthesiologists (ASA) Physical Status Class-I and II.
  • Scheduled for lumbosacral surgery under General Anesthesia.

Who cannot join

  • Declining to give written informed consent or patients with significant cognitive dysfunction that hinders informed consent.
  • History of allergy to the medications used in the study.
  • Contraindications to regional anesthesia (including coagulopathy and local infection).
  • History of recent analgesic intake or abuse.
  • Pregnancy or lactating mothers.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Salma Ayman Abdulazeem, MSc contact

+201285665828

Salmaaymen0103389@med.asu.edu.eg

Egypt1 site, 1 recruiting
  • Ain Shams University hospitals

    Cairo

    Dr. Salma Ayman, MSc., +201285665828, Salmaaymen0103389@med.asu.edu.eg

    Recruiting

Other trials in Egypt

About this study

Official title: Effect of Adding Dexmedetomidine Versus Ketamine to Bupivacaine in Fluoroscopy Guided Caudal Analgesia for Lumbosacral Surgeries Under General Anaesthesia; a Randomised Controlled Double Blinded Study

This study will evaluate the effect of adding dexmedetomidine to bupivacaine compared to ketamine in the caudal block on perioperative analgesia in patients undergoing lumbosacral surgeries under general anesthesia.

Read the detailed description

Preoperative settings:

All participants will be clinically assessed (history, duration of illness and medications especially analgesic history) and routine preoperative investigations will be done; CBC, Coagulation profile, liver function tests, kidney function tests, random blood sugar and ECG.

Also preoperatively, participants will be trained how to use visual analog scale (VAS) to assess pain severity. Scores will be recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

Intraoperative settings and technique:

On arrival of the participant to the operative room, standard monitoring including electrocardiography, non-invasive blood pressure, and pulse oximetry will be applied.

Baseline parameters of vital data and oxygen saturation will be recorded. An Intravenous (IV) line will be inserted. Premedication using IV injection of Midazolam 0.02mg/kg, Granisetron 3mg and Pantoprazole 40 mg will be administered slowly IV.

For all groups, induction of general anesthesia will be performed using IV injection of Fentanyl 2μg/kg, Propofol 1mg/kg and Atracurium 0.5mg/kg.

Specific equipment required: 18G Tuohy epidural needle, Loss of resistance epidural syringe, skin antiseptic solution, sterile gloves and portable C-arm fluoroscopy.

After securing the airway, patient stabilization and proper positioning in the prone position, the caudal block will be performed.

An 18-gauge Tuohy-type needle will be inserted in the midline into the caudal canal under C-arm guidance. A slight "snap" feeling may be appreciated when the advancing needle pierces the sacrococcygeal ligament. Once the needle reaches the ventral wall of the sacral canal, it will be slowly withdrawn and reoriented, directing it more cranially (by the depressing hub and advancing) for further insertion into the canal.

The investigators will utilize the anteroposterior view once the epidural needle is safely situated within the canal. In this projection, the intermediate sacral crests will appear as opaque vertical lines on either side of the midline. The sacral foramina will be visualized as translucent and nearly circular areas lateral to the intermediate sacral crests. A syringe loaded with 3-4 ml of iohexol 180mgI/ml contrast material will be used to document epidural spread and exclude intravascular injection.

For all groups, using IV injection of Paracetamol (15 mg/ kg) and Ketorolac (30 mg) as a part of multimodal analgesia will be administered.

Intraoperative bradycardia (HR <60 beats/min) will be managed with atropine 0.01 mg/kg and hypotension (systolic arterial pressure <90 mmHg) will be managed with 20 ml/kg lactated Ringer and ephedrine 5mg increments if needed. If the patient has tachycardia (>20% of the baseline) and/or hypertension (MAP >20% of the baseline), 50μg fentanyl will be given IV slowly.

At the end of surgery, anesthesia will be discontinued and the muscle relaxant will be reversed by neostigmine 0.05mg/kg, atropine 0.02mg/kg and the patient will be transferred to PACU.

HR, MAP and oxygen saturation will be measured upon arrival to the PACU and after 5 minutes, then every 10 minutes till the patient discharge from PACU.

Caudal Block Technique:

All patients will be in prone position. A dry gauze swab will be placed in the intergluteal cleft to protect the anal area and genitalia from povidone iodine which will be used to disinfect the skin. Anatomical landmarks will be next assessed. A triangle may be marked on the skin over the sacrum, using the posterior superior iliac spines (PSISs) as the base, with the apex pointing inferiorly (caudally). Normally, this apex sits over or immediately adjacent to the sacral hiatus. Once the hiatus is marked, the tip of the index finger will be placed on the tip of the coccyx in the intergluteal cleft while the thumb of the same hand palpates the two sacral cornua located 3-4 cm more rostrally at the upper end of the intergluteal cleft. The sacral cornua may be identified by gently moving the palpating index finger from side to side. The palpating thumb should sink into the hollow between the two cornua, as if between two knuckles of a fist. Sterile skin preparation and draping of the entire region will be performed in the usual fashion.

Fluoroscopy will be utilized, a lateral view will be obtained to demonstrate the anatomic boundaries of the sacral canal. The caudal canal will appear as a translucent layer posterior to the sacral segments. The median sacral crest is visualized as an opaque line posterior to the caudal canal. The sacral hiatus is usually visualized as a translucent opening at the base of the caudal canal. The coccyx may be seen articulating with the inferior surface of the sacrum.

In Group C: The participants will receive isobaric bupivacaine (0.125%) total volume of 20 ml.

In Group D: The participants will receive isobaric bupivacaine (0.125%) total volume of 18 ml + 2μg/kg dexmedetomidine total volume of 2 ml.

In Group K: The participants will receive isobaric bupivacaine (0.125%) total volume of 18 ml + 1mg/kg ketamine total volume of 2 ml.

Postoperative settings:

After the patient will be discharged from the operating room, (VAS) will be used to assess the acute postoperative pain. The (VAS) will be recorded at intervals 0 (at PACU), 2, 4, 6, 8, 12, 16 and 24 hours postoperatively.

All patients will receive IV ketorolac 30 mg and paracetamol 1 gm every 8 hours.

If VAS is ≥ 3 postoperatively, a rescue drug will be given; IV morphine (0.01mg/kg) and will be repeated on demand maximally every 6 hours. Time and dose will be recorded.

Any side effects will be recorded as hypotension (systolic arterial pressure <90 mmHg), arrhythmia, bradycardia (HR <60 beats/min), nausea or vomiting, pruritis or any other complications.

Atropine 0.01 mg/kg will be given in response to bradycardia and 20 ml/kg lactated Ringer will be given in response to hypotension.

In the surgical ward, the following will be recorded in the three groups :

Pain intensity (using VAS) will be assessed every 2 hours in the first 8 hours then every 4 hours in the next 8 hours then at 24 hours postoperatively.

Time for first rescue analgesia. Total morphine consumption in the first 24 hours. Postoperative nausea and vomiting. Vital data every 2 hours in the first 8 hours then every 4 hours in the next 8 hours then at 24 hours postoperatively.

All parameters will be collected by a data assessor who will be blinded to the drug injected in the caudal block.

Being tested
Group C (plain bupivacaine (0.125%)), Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine), Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine)
Keywords
Caudal analgesia, Adult caudal blocks, Lumbosacral surgeries, Caudal ketamine, Caudal dexmedetomidine

What participants receive

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

  • Group C (plain bupivacaine (0.125%))Drug

    The patients will receive 20ml plain bupivacaine (0.125%) in the caudal block

  • Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine)Drug

    The patients will receive 20ml plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine in the caudal block

  • Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine)Drug

    The patients will receive 20ml plain bupivacaine (0.125%) + 1mg/kg ketamine in the caudal block

Study groups in NCT07573969
Study groupRoleWhat they receive
ControlActive comparatorThe patients will receive 20ml plain bupivacaine (0.125%) in the caudal block
Receives: Drug: Group C (plain bupivacaine (0.125%))
DexmedetomidineActive comparatorThe patients will receive 20ml plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine in the caudal block
Receives: Drug: Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine)
KetamineActive comparatorThe patients will receive 20ml plain bupivacaine (0.125%) + 1mg/kg ketamine in the caudal block
Receives: Drug: Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine)

What is being measured

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

  1. Duration of postoperative analgesia when VAS score ≥ 3.

    Duration of postoperative analgesia (the time from the end of giving the caudal analgesia to the first given dose of morphine) when VAS score ≥ 3.

    Measured: Immediately after giving the caudal block and up to 24 hours postoperatively.

Secondary outcomes (1)
  1. The total dose of used morphine postoperatively/patient (rescue analgesia) for first 24 hours, PONV and hemodynamic effects.

    Measured: First 24 hours postoperative.

Timeline

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

  1. First posted7 May 2026
  2. Study startMay 2026 (estimated)
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

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 3
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07573969
Sponsor's protocol ID
FMASU MD290/2025
Status last verified
Apr 2026
First submitted
25 Apr 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Goyal V, Kubre J, Radhakrishnan K. Dexmedetomidine as an adjuvant to bupivacaine in caudal analgesia in children. Anesth Essays Res. 2016 May-Aug;10(2):227-32. doi: 10.4103/0259-1162.174468.

    PubMed 27212752
  • Wiegele M, Marhofer P, Lonnqvist PA. Caudal epidural blocks in paediatric patients: a review and practical considerations. Br J Anaesth. 2019 Apr;122(4):509-517. doi: 10.1016/j.bja.2018.11.030. Epub 2019 Feb 1.

    PubMed 30857607
  • Barham G, Hilton A. Caudal epidurals: the accuracy of blind needle placement and the value of a confirmatory epidurogram. Eur Spine J. 2010 Sep;19(9):1479-83. doi: 10.1007/s00586-010-1469-8. Epub 2010 May 29.

    PubMed 20512512
  • Beyaz SG, Tokgoz O, Tufek A. Caudal epidural block in children and infants: retrospective analysis of 2088 cases. Ann Saudi Med. 2011 Sep-Oct;31(5):494-7. doi: 10.4103/0256-4947.84627.

    PubMed 21911987
  • Mossetti V, Vicchio N, Ivani G. Local anesthetis and adjuvants in pediatric regional anesthesia. Curr Drug Targets. 2012 Jun;13(7):952-60. doi: 10.2174/138945012800675713.

    PubMed 22512395
  • Bajwa SJ, Bajwa SK, Kaur J, Singh G, Arora V, Gupta S, Kulshrestha A, Singh A, Parmar S, Singh A, Goraya S. Dexmedetomidine and clonidine in epidural anaesthesia: A comparative evaluation. Indian J Anaesth. 2011 Mar;55(2):116-21. doi: 10.4103/0019-5049.79883.

    PubMed 21712865
  • Solanki SL, Bharti N, Batra YK, Jain A, Kumar P, Nikhar SA. The analgesic effect of intrathecal dexmedetomidine or clonidine, with bupivacaine, in trauma patients undergoing lower limb surgery: a randomised, double-blind study. Anaesth Intensive Care. 2013 Jan;41(1):51-6. doi: 10.1177/0310057X1304100110.

    PubMed 23362890
  • Vetter TR, Carvallo D, Johnson JL, Mazurek MS, Presson RG Jr. A comparison of single-dose caudal clonidine, morphine, or hydromorphone combined with ropivacaine in pediatric patients undergoing ureteral reimplantation. Anesth Analg. 2007 Jun;104(6):1356-63, table of contents. doi: 10.1213/01.ane.0000261521.52562.de.

    PubMed 17513626
  • Sekar C, Rajasekaran S, Kannan R, Reddy S, Shetty TA, Pithwa YK. Preemptive analgesia for postoperative pain relief in lumbosacral spine surgeries: a randomized controlled trial. Spine J. 2004 May-Jun;4(3):261-4. doi: 10.1016/j.spinee.2003.11.009.

    PubMed 15125846
  • Sabbar S, Zamir AK, Khan FA: Caudal ketamine with bupivacaine and bupivacaine alone for postoperative analgesia in paediatric inguino-scrotal surgeries. Med Channel. 2009; 4:207-210.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Group C (plain bupivacaine (0.125%)), Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine) and Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine) in people with Perioperative Analgesia, run by Ain Shams 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 7 May 2026. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Salma Ayman Abdulazeem, MSc (+201285665828, Salmaaymen0103389@med.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of postoperative analgesia when VAS score ≥ 3. (time frame: Immediately after giving the caudal block and up to 24 hours postoperatively.). 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 NCT07573969, which also lists 10 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 7 May 2026.

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