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

5 mei 2026 bijgewerkt door: Ain Shams University

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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

72

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ander
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Control
The patients will receive 20ml plain bupivacaine (0.125%) in the caudal block
The patients will receive 20ml plain bupivacaine (0.125%) in the caudal block
Actieve vergelijker: Dexmedetomidine
The patients will receive 20ml plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine in the caudal block
The patients will receive 20ml plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine in the caudal block
Actieve vergelijker: Ketamine
The patients will receive 20ml plain bupivacaine (0.125%) + 1mg/kg ketamine in the caudal block
The patients will receive 20ml plain bupivacaine (0.125%) + 1mg/kg ketamine in the caudal block

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Duration of postoperative analgesia when VAS score ≥ 3.
Tijdsspanne: Immediately after giving the caudal block and up to 24 hours postoperatively.
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.
Immediately after giving the caudal block and up to 24 hours postoperatively.

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
The total dose of used morphine postoperatively/patient (rescue analgesia) for first 24 hours, PONV and hemodynamic effects.
Tijdsspanne: First 24 hours postoperative.
First 24 hours postoperative.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Publicaties en nuttige links

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Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 mei 2026

Primaire voltooiing (Geschat)

1 mei 2027

Studie voltooiing (Geschat)

1 mei 2027

Studieregistratiedata

Eerst ingediend

25 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

5 mei 2026

Eerst geplaatst (Werkelijk)

7 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

7 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

5 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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