Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty
NCT ID: NCT07194694
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2025-10-22
2026-01-30
Brief Summary
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To what extent do dexmedetomidine and ketamine adjuvants, when combined with bupivacaine, offer a longer analgesic period in a Transversus Abdominis Plane (TAP) block?
To investigate the pain at rest and coughing with particular time intervals (0, 2, 4, 6, and 12 hours) after the operation.
researchers will rely on three groups:
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.
Group B (ketamine group): patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.
Group C (Control Group): Patients will receive 20 ml of solution containing 1 mg/kg bupivacaine + normal saline.
Participants will:
have general anesthesia in their planned unilateral hernioplasty. have an ipsilateral US guided TAP block (posterior approach) using one of the three study solutions at the end of the surgery prior to be waked up.
Measure their Numeric Pain Rating Scale (NRS) at rest and coughing at particular time intervals (0, 2, 4, 6, and 12 hours) after the operation.
Detailed Description
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Patients scheduled for unilateral inguinal hernioplasty will be assessed preoperatively by evaluating their medical history, laboratory investigations, and fulfillment of the above inclusion criteria. The patient's preparation will be done by IV cannulation with an 18G cannula, and infusion of 500 ml of Ringer's solution will be started, and about 20 minutes before anesthesia induction, midazolam (0.05 mg/kg) will be received as a sedative premedication.
Intraoperative Procedures and Assessments:
After reaching the operating room, standard monitoring will be applied, which includes electrocardiography (ECG), non-invasive blood pressure, and pulse oximetry for peripheral oxygen saturation (SPO2). After preoxygenation, induction of general anesthesia will be done by IV injection of propofol (2 mg/kg), fentanyl (2 mcg/kg), atracurium (0.5 mg/kg), and inhalational isoflurane 1.2%, followed by endotracheal intubation and controlled mechanical ventilation with tidal volume 7-8 ml/kg, respiratory rate 12/min, and FIO₂ 100%. Then anesthesia will be maintained by inhalational isoflurane, atracurium 0.1 mg/kg every 20 minutes, and intraoperative fluid (Ringer's solution), which was calculated to cover the maintenance, deficit, and 3rd space requirement.
At the end of surgery an ipsilateral US-guided TAP block will be given to all the patients by placing a linear US probe (high-frequency probe 10-12 MHz) connected to a portable US unit initially in the mid-axillary plane midway between the lower costal margin and the highest point of iliac crest, then it was moved posteriorly till a scan reveals the transversus abdominis muscle tailing off into the aponeurosis, near the Quadratus lumborum muscle. The injection site was superficial to the aponeurosis near quadratus lumborum. while the patient in supine position with slight lateralization After skin disinfection, a 22-G needle with an injection line will be inserted in plane with the probe. Once the tip of the needle is placed in place, and after negative suction, 5 ml of 0.9% saline will be injected to verify the right place, then one of the three study solutions will be injected.
Group A (Dexmedetomidine Group): patients received 20 ml solution containing 1 mg/kg bupivacaine + 1 mcg/kg dexmedetomidine + normal saline.
Group B (Ketamine Group): patients received 20 ml solution containing 1 mg/kg bupivacaine + 0.5 mg/kg ketamine + normal saline.
Group C (Control Group): Patients received 20 ml of solution containing 1 mg/kg bupivacaine + normal saline.
Then discontinuation of inhalational isoflurane and reversal of muscle blockade by a neostigmine 0.05 mg/kg and atropine (0.01-0.02 mg/kg) mixture, and after fulfillment of extubation criteria, extubation was done.
Postoperative analgesic regimen:
When NRS \>3: Nalbuphine (0.1 mg/kg) will be given.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Concealment: Randomization list will be concealed from all members off the study, known only by one person which is not included in it.
Study Groups
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DEX on TAP
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.
Dexmedetomidine & Bupivacaine.
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.
KET on TAP
Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.
ketamine and bupivacaine injection
Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.
TAP
Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.
Bupivacaine
Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.
Interventions
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Dexmedetomidine & Bupivacaine.
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.
ketamine and bupivacaine injection
Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.
Bupivacaine
Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.
Eligibility Criteria
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Inclusion Criteria
* Age group: 18-60 years old.
Exclusion Criteria
* known allergy to any of the used drugs
* ASA III or above
* Coagulation disorders and thrombocytopenia
* Body mass index (BMI) \>30
* Infection at needle insertion site
* Patients undergoing bilateral inguinal hernioplasty
18 Years
60 Years
ALL
No
Sponsors
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Ain Shams University
OTHER
Responsible Party
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Mariam Mikhail Fouad Hanna
Assistant Lecturer at Department: Anesthesiology, Intensive Care and Pain Management, Faculty of Medicine, Ain Shams University.
Locations
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Ain Shams University Hospitals
Cairo, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Mariam M Fouad
Role: primary
Other Identifiers
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MD 42
Identifier Type: -
Identifier Source: org_study_id