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

May 5, 2026 updated by: 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Once the needle reaches the ventral wall of the sacral canal, it will be slowly withdrawn and reoriented, directing it more cranially (by the depressing hub and advancing) for further insertion into the canal.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.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
The patients will receive 20ml plain bupivacaine (0.125%) in the caudal block
Drug: Group C (plain bupivacaine (0.125%))
The patients will receive 20ml plain bupivacaine (0.125%) in the caudal block
Active Comparator: Dexmedetomidine
The patients will receive 20ml plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine in the caudal block
Drug: Group D (plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine)
The patients will receive 20ml plain bupivacaine (0.125%) + 2μg/kg dexmedetomidine in the caudal block
Active Comparator: Ketamine
The patients will receive 20ml plain bupivacaine (0.125%) + 1mg/kg ketamine in the caudal block
Drug: Group K (plain bupivacaine (0.125%) + 1mg/kg ketamine)
The patients will receive 20ml plain bupivacaine (0.125%) + 1mg/kg ketamine in the caudal block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of postoperative analgesia when VAS score ≥ 3.
Time Frame: 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.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 25, 2026

First Submitted That Met QC Criteria

May 5, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU MD290/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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