Postoperative Pain ReliefPhase 3DEX\KET in TAPNCT07194694
Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty
A Phase 3 study testing Dexmedetomidine & Bupivacaine., ketamine and bupivacaine injection and Bupivacaine in people with Postoperative Pain Relief, run by Ain Shams University at 1 site in Egypt.
Trial summary
This clinical trial aims to compare the effect of adding dexmedetomidine versus ketamine to bupivacaine in transversus abdominis plane block in patients undergoing unilateral inguinal hernioplasty. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain Relief
- What is being tested?
- Dexmedetomidine & Bupivacaine., ketamine and bupivacaine injection and Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Oct 2025to 20 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing unilateral inguinal hernioplasty of ASA I or II.
- Age group: 18-60 years old.
Who cannot join
- Patient refusal.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty: A Randomized Clincal Controlled Trial
This clinical trial aims to compare the effect of adding dexmedetomidine versus ketamine to bupivacaine in transversus abdominis plane block in patients undergoing unilateral inguinal hernioplasty. The key questions it is expected to answer are:
To what extent do dexmedetomidine and ketamine adjuvants, when combined with bupivacaine, offer a longer analgesic period in a Transversus Abdominis Plane (TAP) block?
Read more
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.
Read the detailed description
Preoperative Assessment:
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
- Postoperative Pain Relief
- Being tested
- Dexmedetomidine & Bupivacaine., ketamine and bupivacaine injection, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine & Bupivacaine.Drug
Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline.
ketamine and bupivacaine injectionDrug
Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline.
BupivacaineDrug
Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline.
| Study group | Role | What they receive |
|---|---|---|
| DEX on TAP | Active comparator | Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline. Receives: Drug: Dexmedetomidine & Bupivacaine. |
| KET on TAP | Active comparator | Group B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline. Receives: Drug: ketamine and bupivacaine injection |
| TAP | Placebo comparator | Group C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Numeric Pain Rating Scale
The Numeric Pain Rating Scale (NRS) is an effective method for measuring pain intensity. It consists of an 11-point scale where:
0 represents no pain - 10 represents the worst pain imaginable. Patients are asked to select a whole number that best reflects their pain intensity or average pain level.
Measured: Immediately postoperative - 2 hours postoperatively - 4 hours postoperatively - 6 hours postoperatively - 12 hours postoperatively
Secondary outcomes (1)
Change in Mean arterial blood pressure
MAP = Diastolic Blood Pressure + (1/3 * Pulse Pressure). It is the average pressure in your arteries throughout one cardiac cycle and will be calculated after measuring the blood pressure of the patients postoperatively.
Measured: Immediately postoperative - 2 hours postoperative - 4 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start22 Oct 2025
- Primary completion15 Jan 2026
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ReliefStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At the end of surgery an ipsilateral US guided TAP block (posterior approach) will be given to all the patients by placing 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 will be moved posteriorly till a scan reveals the transversus abdominis muscle tailing off into the aponeurosis, near the Quadratus lumborum muscle. The injection site is 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 saline 0.9% will be injected to verify the right place, then one of the three study solutions will be injected.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariam Mikhail Fouad Hanna, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194694
- Sponsor's protocol ID
- MD 42
- Acronym
- DEX\KET in TAP
- Status last verified
- Jan 2026
- First submitted
- 19 Sep 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine vs Ketamine as Adjuvants to Bupivacaine in Transversus Abdominus Plane Block in Inguinal Hernioplasty: A Randomized Clincal Controlled Trial
- ClinicalTrials.gov ID
- NCT07194694
- Acronym / sponsor ID
- DEX\KET in TAP / MD 42
- Conditions
- Postoperative Pain Relief
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to compare the effect of adding dexmedetomidine versus ketamine to bupivacaine in transversus abdominis plane block in patients undergoing unilateral inguinal hernioplasty. The key questions it is expected to answer are:
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
Preoperative Assessment:
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- At the end of surgery an ipsilateral US guided TAP block (posterior approach) will be given to all the patients by placing 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 will be moved posteriorly till a scan reveals the transversus abdominis muscle tailing off into the aponeurosis, near the Quadratus lumborum muscle. The injection site is 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 saline 0.9% will be injected to verify the right place, then one of the three study solutions will be injected.
| Arm | Type | Receives |
|---|---|---|
| DEX on TAP | Active comparator | Drug: 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 | Active comparator | Drug: ketamine and bupivacaine injectionGroup B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline. |
| TAP | Placebo comparator | Drug: BupivacaineGroup C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing unilateral inguinal hernioplasty of ASA I or II.
- Age group: 18-60 years old.
Key exclusion criteria (7 listed)
- Patient refusal.
- known allergy to any of the used drugs
- ASA III or above
- Coagulation disorders and thrombocytopenia
- Body mass index (BMI) >30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine & Bupivacaine.Group A (Dexmedetomidine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine + 1mcg/kg dexmedetomidine +normal saline. | Drug | DEX on TAP |
| ketamine and bupivacaine injectionGroup B (ketamine Group): patients will receive 20 ml solution containing 1 mg/kg bupivacaine+0.5 mg/kg ketamine + normal saline. | Drug | KET on TAP |
| BupivacaineGroup C (Control Group): Patients will receive 20 ml solution containing 1 mg/kg bupivacaine + normal saline. | Drug | TAP |
Primary outcome
Change in Numeric Pain Rating Scale
Time frame: Immediately postoperative - 2 hours postoperatively - 4 hours postoperatively - 6 hours postoperatively - 12 hours postoperatively
The Numeric Pain Rating Scale (NRS) is an effective method for measuring pain intensity. It consists of an 11-point scale where: 0 represents no pain - 10 represents the worst pain imaginable. Patients are asked to select a whole number that best reflects their pain intensity or average pain level.
1 secondary outcome
Change in Mean arterial blood pressure
Time frame: Immediately postoperative - 2 hours postoperative - 4 hours postoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexmedetomidine & Bupivacaine., ketamine and bupivacaine injection and Bupivacaine in people with Postoperative Pain Relief, 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 21 Jan 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Numeric Pain Rating Scale (time frame: Immediately postoperative - 2 hours postoperatively - 4 hours postoperatively - 6 hours postoperatively - 12 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.