Post Operative PainNCT06032624
Ketamine and Dexmedetomidine Comparative Study
A study testing combined ultra-sound guided femoral and sciatic nerve block. in people with Post Operative Pain, run by Sohag University.
Trial summary
In this study, the investigators will compare the effect of adding ketamine and dexmedetomidine to bupivacaine in US-guided combined sciatic and femoral nerve blocks as regards the onset and duration of the block, postoperative visual analogue scale, and analgesic consumption.50 patients with American Society of… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- combined ultra-sound guided femoral and sciatic nerve block.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 Jul 2025
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.
- -
Who cannot join
- Patient refusal.
- Patient with significant neurological, psychiatric or neuromuscular disease.
- Alcoholism.
- Drug abuse.
- Pregnancy or lactating women.
- Suspected Coagulopathy.
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- Morbid obesity.
- Known allergy to study medications.
- Septicaemia and local infection at the block site.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Study Between Ketamine and Dexmedetomidine as Additives to Local Anesthetic in Ultrasound-guided Combined Sciatic and Femoral Nerve Block
In this study, the investigators will compare the effect of adding ketamine and dexmedetomidine to bupivacaine in US-guided combined sciatic and femoral nerve blocks as regards the onset and duration of the block, postoperative visual analogue scale, and analgesic consumption.50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.
Read the detailed description
The patients will be randomly classified into two groups:
Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine, Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine.
Femoral nerve block: The femoral area will be sterilized using povidone-iodine and alcohol and then drapes will be put on the patient's thigh, with the operator on the right-hand side for blocks on both sides and vice versa for a left-handed operator. The ultrasound machine will be placed on the opposite side so that the operator's line of sight, the needle, and the screen are in a straight line. The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., medial to the lateral sliding movements of the transducer-aided visualization of the pulsatile femoral artery. Structures that will be visualized: fascia iliac, femoral artery, immediately below, and lateral is the femoral nerve in a wedge-shaped space. The femoral nerve typically is hyperechoic and lies in a sulcus in the iliopsoas inferiorly. In-line insertion of the needle to reach below fascia iliaca and then a volume of 15 ml of bupivacaine will be injected to perform the block.
Sciatic nerve block: The patient will be positioned with the side for the block uppermost, flexed partially at the hip and knee joints. The iliac area will be sterilized using povidone-iodine and alcohol, and then drapes will be put on the patient's thigh, with the operator on the right-hand side for blocks on both sides and vice versa for a lefthanded operator. The ultrasound machine will be placed on the opposite side so that the operator's line of sight, the needle, and the screen is in a straight line. A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences; the gluteus maximus muscle is as the most superficial muscular layer bridging the two osseous structures; sciatic nerve lies deep into the gluteus maximus muscle and superficial to the quadratus femoris muscle as an oval or roughly triangular hyperechoic structure. A volume of 25 ml of bupivacaine will be injected to perform the block.
The onset and duration of sensory loss and motor blockade will be studied. The loss of pinprick sensation will be checked every 5 minutes till the onset of loss of sensation and then every 2 hours till the regain of sensation. The motor blockade will be assessed every 5 minutes till the loss of movements and then every 2 hours till the regain of movements.
The onset of action: Sensory and motor blockade Sensory block: The time interval between full deposition of local anesthetic solution till loss of pinprick sensation at the site of surgery.
Motor block: The time interval between administering the local anesthetic solution to the loss of movements.
Duration of blockade:
Sensory block: Time interval between loss of pinprick sensation to the appearance of pinprick sensation.
Motor block: Time interval between loss of movements to the appearance of the movements.
The basal heart rate (HR); noninvasive arterial systolic blood pressure (SBP) and diastolic blood pressure (DBP); and peripheral oxygen saturation (SpO2) will be recorded. An 18-gauge (G) i.v. the cannula will be inserted in the non-operated arm and lactated Ringer's solution will be started at 5 ml/kg/h.
HR, SBP, and DBP will also be recorded at 0, 5, 10, 15, 30, 45-, 60-, 90-, and 120-min. Adverse effects will be considered as hypotension (i.e., 20% decrease relative to baseline), bradycardia (HR <50 beats/min), nausea, vomiting, and hypoxemia (SpO2 <90%). Any need for additional medication will be noted intraoperatively. Blood loss will be calculated by the gravimetric method and will be replaced if more than the allowable blood loss. Pain will be assessed using a visual analog scale (VRS) (O=no pain 1=mild pain 2=moderate pain 3=severe pain 4=unbearable pain).
- Conditions
- Post Operative Pain
- Being tested
- combined ultra-sound guided femoral and sciatic nerve block.
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined ultra-sound guided femoral and sciatic nerve block.Procedure or surgery
Femoral nerve block, The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm, and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., the volume of 15 ml of bupivacaine will be injected to perform the block. Sciatic nerve block, A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences,A volume of 25 ml of bupivacaine will be injected to perform the block.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine group (group K) | Active comparator | Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine. Receives: Procedure: combined ultra-sound guided femoral and sciatic nerve block. |
| Dexmedetomidine group (group D) | Active comparator | Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine. Receives: Procedure: combined ultra-sound guided femoral and sciatic nerve block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
the onset of the femoral nerve block
The time interval between the deposition of the local anesthetic and the loss of pinprick sensation at the site of surgery.
Measured: from the deposition of the local anesthetic till the loss of pinprick sensation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Ahmed Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032624
- Sponsor's protocol ID
- Soh-Med-22-07-34
- Status last verified
- Sep 2023
- First submitted
- 9 Nov 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Ketamine and Dexmedetomidine as Additives to Local Anesthetic in Ultrasound-guided Combined Sciatic and Femoral Nerve Block
- ClinicalTrials.gov ID
- NCT06032624
- Acronym / sponsor ID
- Soh-Med-22-07-34
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 13 Sep 2023 (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.
In this study, the investigators will compare the effect of adding ketamine and dexmedetomidine to bupivacaine in US-guided combined sciatic and femoral nerve blocks as regards the onset and duration of the block, postoperative visual analogue scale, and analgesic consumption.50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.
Detailed description
The patients will be randomly classified into two groups:
Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine, Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine.
Femoral nerve block: The femoral area will be sterilized using povidone-iodine and alcohol and then drapes will be put on the patient's thigh, with the operator on the right-hand side for blocks on both sides and vice versa for a left-handed operator. The ultrasound machine will be placed on the opposite side so that the operator's line of sight, the needle, and the screen are in a straight line. The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., medial to the lateral sliding movements of the transducer-aided visualization of the pulsatile femoral artery. Structures that will be visualized: fascia iliac, femoral artery, immediately below, and lateral is the femoral nerve in a wedge-shaped space. The femoral nerve typically is hyperechoic and lies in a sulcus in the iliopsoas inferiorly. In-line insertion of the needle to reach below fascia iliaca and then a volume of 15 ml of bupivacaine will be injected to perform the block.
Sciatic nerve block: The patient will be positioned with the side for the block uppermost, flexed partially at the hip and knee joints. The iliac area will be sterilized using povidone-iodine and alcohol, and then drapes will be put on the patient's thigh, with the operator on the right-hand side for blocks on both sides and vice versa for a lefthanded operator. The ultrasound machine will be placed on the opposite side so that the operator's line of sight, the needle, and the screen is in a straight line. A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences; the gluteus maximus muscle is as the most superficial muscular layer bridging the two osseous structures; sciatic nerve lies deep into the gluteus maximus muscle and superficial to the quadratus femoris muscle as an oval or roughly triangular hyperechoic structure. A volume of 25 ml of bupivacaine will be injected to perform the block.
The onset and duration of sensory loss and motor blockade will be studied. The loss of pinprick sensation will be checked every 5 minutes till the onset of loss of sensation and then every 2 hours till the regain of sensation. The motor blockade will be assessed every 5 minutes till the loss of movements and then every 2 hours till the regain of movements.
The onset of action: Sensory and motor blockade Sensory block: The time interval between full deposition of local anesthetic solution till loss of pinprick sensation at the site of surgery.
Motor block: The time interval between administering the local anesthetic solution to the loss of movements.
Duration of blockade:
Sensory block: Time interval between loss of pinprick sensation to the appearance of pinprick sensation.
Motor block: Time interval between loss of movements to the appearance of the movements.
The basal heart rate (HR); noninvasive arterial systolic blood pressure (SBP) and diastolic blood pressure (DBP); and peripheral oxygen saturation (SpO2) will be recorded. An 18-gauge (G) i.v. the cannula will be inserted in the non-operated arm and lactated Ringer's solution will be started at 5 ml/kg/h.
HR, SBP, and DBP will also be recorded at 0, 5, 10, 15, 30, 45-, 60-, 90-, and 120-min. Adverse effects will be considered as hypotension (i.e., 20% decrease relative to baseline), bradycardia (HR <50 beats/min), nausea, vomiting, and hypoxemia (SpO2 <90%). Any need for additional medication will be noted intraoperatively. Blood loss will be calculated by the gravimetric method and will be replaced if more than the allowable blood loss. Pain will be assessed using a visual analog scale (VRS) (O=no pain 1=mild pain 2=moderate pain 3=severe pain 4=unbearable pain).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine group (group K) | Active comparator | Procedure: combined ultra-sound guided femoral and sciatic nerve block.Ketamine group (group K):40 ml 0.5%bupivacaine and 0.5 mg\kg ketamine. |
| Dexmedetomidine group (group D) | Active comparator | Procedure: combined ultra-sound guided femoral and sciatic nerve block.Dexmedetomidine group (group D) 40 ml 0.5% bupivacaine and 50µg\kg dexmedetomidine. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 50 patients with American Society of Anesthesiologists (ASA) grade I to II, 18 to 60 years of age scheduled for below-knee surgeries, Will be included in the study.
- -
Key exclusion criteria (9 listed)
- Patient refusal.
- Patient with significant neurological, psychiatric or neuromuscular disease.
- Alcoholism.
- Drug abuse.
- Pregnancy or lactating women.
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 |
|---|---|---|
| combined ultra-sound guided femoral and sciatic nerve block.Femoral nerve block, The femoral area will be scanned behind the midpoint of the inguinal ligament and the depth of the image will be set at 3-5 cm, and a linear high frequency 8-12MHz) probe will be placed perpendicular to the course of the femoral nerve., the volume of 15 ml of bupivacaine will be injected to perform the block. Sciatic nerve block, A curvilinear low-frequency (3-9 MHz) probe will be used to do a scan of the sub-gluteal region below a line from the ischial tuberosity and greater trochanter which are seen as two hyperechoic bony prominences,A volume of 25 ml of bupivacaine will be injected to perform the block. | Procedure or surgery | Dexmedetomidine group (group D), Ketamine group (group K) |
Primary outcome
the onset of the femoral nerve block
Time frame: from the deposition of the local anesthetic till the loss of pinprick sensation
The time interval between the deposition of the local anesthetic and the loss of pinprick sensation at the site of surgery.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing combined ultra-sound guided femoral and sciatic nerve block. in people with Post Operative Pain, run by Sohag University.
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 9 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Mahmoud, MD (00201091328413, mohamedmahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the onset of the femoral nerve block (time frame: from the deposition of the local anesthetic till the loss of pinprick sensation). 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 13 Sep 2023.