Postoperative PainPhase 4NCT04554862
The Analgesic Efficacy of Magnesium and Ketorolac in Ultrasound Supraclavicular Block
A Phase 4 study testing Magnesium sulfate, Ketorolac Tromethamine and supraclavicular block in people with Postoperative Pain, run by Fayoum University Hospital at 1 site in Egypt.
Trial summary
Despite many regional anesthetic techniques have been described for anesthesia of the brachial plexus which is responsible for the sensory and motor innervation of entire upper limb, still, supraclavicular block (SCB) is the regional anesthetic technique of choice. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Magnesium sulfate, Ketorolac Tromethamine and supraclavicular block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2019to 30 Oct 2020
- Phase
- Phase 4
- 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
- American Society of Anesthesiologists (ASA) physical status from I to III participants who were scheduled for surgical procedures of the arm from elbow to hand
Who cannot join
- Patient refusal.
- Contraindication to regional anesthesia (coagulopathy, allergy to the local anesthetic or any adjuvants added, severe thrombocytopenia, pre-existing neuropathy in the operative limb, infection at puncture site).
- Sepsis.
- Pregnant or lactating women.
- Hepatic or renal dysfunction.
- Any drug or opioid abuse.
- Surgical procedures for more than 3h.
- Advanced cardiac diseases.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Fayoum University hospital
El Fayoum Qesm, Faiyum Governorate, 63514
About this study
Official title: The Analgesic Efficacy of Adding Magnesium Sulfate Versus Ketorolac to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Block (A Prospective- Double-blinded Randomized Controlled Trial)
Despite many regional anesthetic techniques have been described for anesthesia of the brachial plexus which is responsible for the sensory and motor innervation of entire upper limb, still, supraclavicular block (SCB) is the regional anesthetic technique of choice.
SCB has been described as the spinal anesthesia of the upper limb as it offers dense anesthesia of the brachial plexus for the surgical procedures below the arm from elbow to hand. Although the SCB has a high incidence of complications like pneumothorax, the use of ultrasound-guided block improved the safety for the patient. There are several adjuvants have been added to SCB aiming for prolongation of the duration of peripheral nerve block as fentanyl, alpha 2 adrenergic agonist (Dexmedetomidine, Clonidine), tramadol, ketorolac and Magnesium sulfate.
Read more
Magnesium has anti-nociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells. Calcium influx leads to a sequence of central sensitization such as windup phenomenon and long term potentiation which are crucial mechanisms that determine the duration and intensity of post-operative pain. Magnesium prevents central sensitization triggered by peripheral nociceptive stimulation in response to painful stimuli.
Non-Steroidal Anti-Inflammatory drugs (NSAID) inhibit synthesis of prostaglandins from arachnoid acid in phospholipid membranes resulting in decreased afferent nociceptive signals from the site of surgery. There are a lot of studies supported the analgesic effect when NSAIDs are concentrated at a peripheral site compared to the systemic administration therapy. Ketorolac is a parenteral NSAIDs. Studies have shown that ketorolac as an adjuvant to local anesthetics during peripheral nerve block enhanced duration and quality of analgesia.
Read the detailed description
Eighty adult patients scheduled for upper limb surgeries from elbow to hand will be enrolled in the study after obtaining approval of the local institutional ethics committee and local institutional review board at Fayoum University Hospital. A detailed informed consent will be signed by the eligible participants before recruitment and randomization.
80 patients will be chosen to receive either Mg (group M, n=40) or ketorolac (group K, n=40) randomly by a computer-generated table. The randomization sequence will be concealed in opaque sealed envelopes. The envelopes will be opened by the study investigator just after recruitments and admission to the operation room. Only participants and care providers will be blinded to the group allocations. The consolidated standards of reporting trials (CONSORT) recommendations for reporting randomized, controlled clinical trials will be followed.
Patient preoperative preparations:
Preoperative investigations will be done according to the local protocol designed to evaluate the patients. It will include complete blood count, blood sugar level, serum urea and creatinine, liver function tests, coagulation profile, and ECG.
Before surgery, the participants will receive education about the (NRS) from (0-10 mm) (where 0=no pain and 10 = worst comprehensible pain) and the details of the nerve block procedures.
After a 6h fasting, the patients will be taken to the operating theatre.
Anesthetic technique:
A (20G) IV catheter will be placed in the UL opposite the surgical site after the arrival of the patient to the operating room. IV premedication will be administered to all patients (midazolam 0.02mg/kg and fentanyl 50mcg/dose). Supplemental oxygen (nasal cannula at 2L/min), and standard ASA monitoring (5-lead ECG, NIBP, and pulse oximetry) will be applied throughout the procedure.
Block technique
For the ultrasound-guided SCB, the patients will be placed in a supine position and the head turned slightly to the opposite side of their block. The injured hand will be put on the patient's abdomen and the shoulder will be moved downward as much as possible. The supraclavicular area will be cleaned using an antiseptic iodine solution and draped. Once the skin will be appropriately cleaned and prepared with anti-septic, the high-frequency linear array transducer will be placed over the supraclavicular area. After infiltration of the site by a local anesthetic, a sterile 22 gauge, 50 mm echogenic needle under ultrasound guidance will be inserted and after reaching the tip of the needle near the subclavian artery around the brachial plexus, the solution will be injected and the spread of the drug will be visualized. 25 ml of bupivacaine 0.5% + 6ml of magnesium sulfate 10% will be injected to group M and 25ml of bupivacaine 0.5% + 2ml of ketorolac 30mg + 4ml normal saline will injected to group K. The continuous aspiration and injection will be taken to avoid intravascular injection. After performing the block on the patients, hemodynamic parameters and all complications related to SCB (pneumothorax, hematoma, hypotension, bradycardia, etc.) will be recorded. After ensuring adequate anesthetic effect of the block, the surgery was started.
Assessment of sensory and motor blockade:
The extent of motor and sensory blockade will be evaluated by an anesthesiologist who will not be involved in the SCB 30 minutes. after local anesthetic administration. Using an alcohol swab, the sensory blockade will be tested by pin prick test using a 3- point scale:
Grade 0: normal sensation. Grade 1: decreased pain sensation to pinprick. Grade 2: loss of pain sensation to pinprick in the median, ulnar, radial and musculocutaneous nerve locations.
And it will be tested every 5 minutes for 30 minutes.
Motor blockade will be assessed by using (modified bromage) 3-point scale:
Grade 0: Normal motor function. Grade 1: Decreased motor strength with ability to move fingers only. Grade 2: Complete motor block. And it will be tested every 5 minutes for 30 minutes. When the operation was over, NRS score will be measured at 0, 1, 4, 8, 12, 24 hours.
Post-operative care:
Patients will be transferred to post-anesthetic care unit (PACU) for 2 hours. Then the patients will be discharged from the PACU.
Patient will receive analgesic according to the local institutional protocol as the following (Diclofenac sodium 75mg and paracetamol 1 gram by intravenous infusion over 30 minute.) as a component of multimodal anesthesia regimen for postoperative pain control.
Post-operative pain will be rated on (NRS) from 0 (no pain) to 10 (worst imaginable pain) at 1hr at PACU then at 4,8,12 and 24 hours postoperatively.
Patients with NRS>5 will receive morphine sulfate IV at a bolus dose of 2-5 mg increments with maximum dose of 20 mg at 4hours or 40mg at 24 hours. The morphine titration protocol will be suspended with Oxygen saturation < 95%; Respiratory rate < 10 / minute; the development of sedation (Ramsay sedation scale >2); development of acute adverse effects (allergy, marked itching, excessive vomiting, and hypotension with systolic blood pressure less than 20% of baseline values); or attaining adequate level of analgesia.
- Conditions
- Postoperative Pain
- Being tested
- Magnesium sulfate, Ketorolac Tromethamine, supraclavicular block
- Keywords
- Magnesium, Ketorolac, Supraclavicular 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.
Magnesium sulfateDrug
Also called magnesium 10%
magnesium sulfate will be added to the block
Ketorolac TromethamineDrug
Also called ketorolac
ketorolac will be added to the block
supraclavicular blockProcedure or surgery
it is done by ultrasound- guided
| Study group | Role | What they receive |
|---|---|---|
| the intervention group (M) magnesium sulfate | Active comparator | a 6ml of magnesium sulfate 10% (600mg) will be added to 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block Receives: Drug: Magnesium sulfate; Procedure: supraclavicular block |
| the intervention group (K) ketorolac | Active comparator | a 2ml of ketorolac (30mg) will be added to 4ml of normal saline and 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block Receives: Drug: Ketorolac Tromethamine; Procedure: supraclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the cumulative morphine consumption
In milligrams
Measured: At 24 hours postoperative
Secondary outcomes (17)
numerical rating scale (NRS) of postoperative pain
the severity of postoperative pain estimated by numerical rating scale (NRS) ( where 0 = no pain and 10 = worst imaginable pain)
Measured: at 1 hour in the post-anesthesia care unit (PACU)
numerical rating scale (NRS) of postoperative pain
the severity of postoperative pain estimated by numerical rating scale (NRS) ( where 0 = no pain and 10 = worst imaginable pain)
Measured: at 4 hours postoperative
numerical rating scale (NRS) of postoperative pain
the severity of postoperative pain estimated by numerical rating scale (NRS) ( where 0 = no pain and 10 = worst imaginable pain)
Measured: at 8 hours postoperative
numerical rating scale (NRS) of postoperative pain
the severity of postoperative pain estimated by numerical rating scale (NRS) ( where 0 = no pain and 10 = worst imaginable pain)
Measured: at 12 hours postoperative
numerical rating scale (NRS) of postoperative pain
the severity of postoperative pain estimated by numerical rating scale (NRS) ( where 0 = no pain and 10 = worst imaginable pain)
Measured: at 24 hours postoperative
incidence of opioid related side-effects
side effects (nausea, vomiting, pruritus, excessive sedation, and respiratory depression)
Measured: 5 minutes after supraclavicular block till discharge from PACU
incidence of adverse effects related to the block
adverse events (e.g. vascular puncture, local anesthetic toxicity, and pneumothorax)
Measured: 5 minutes after supraclavicular block till discharge from PACU
time to the first requirement of analgesic supplement
In minutes
Measured: 5 minutes After supraclavicular block till first requirement of analgesic
Duration of surgical procedures
In minutes
Measured: 5 minutes after completion of surgical procedures
Assessment of heart rate
In beats per minutes
Measured: from the start of the block till completion of surgical procedures
Assessment of mean blood pressure
In millimetre mercury (mmHg)
Measured: from the start of the block till completion of surgical procedures
Assessment of respiratory rate
Number of breaths per minute
Measured: from the start of the block till completion of surgical procedures
Assessment of Oxygen saturation
In percentage through use of pulse oximetry
Measured: from the start of the block till completion of surgical procedures
Age
in years
Measured: 10 minutes before surgery
Weight
in kilograms (kg)
Measured: 10 minutes before surgery
Height
in meters (m)
Measured: 10 minutes before surgery
Body mass index
in kg/m square
Measured: 10 minutes before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Oct 2019
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Gaber Ragab, Fayoum University Hospital
- Investigators
- Safaa G Ragab, MD, Principal investigator, Faculty of medicine, Fayoum university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554862
- Sponsor's protocol ID
- M419
- Status last verified
- Oct 2022
- First submitted
- 13 Sep 2020
- Last updated
- 5 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mukherjee K, Das A, Basunia SR, Dutta S, Mandal P, Mukherjee A. Evaluation of Magnesium as an adjuvant in Ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded randomized controlled study. J Res Pharm Pract. 2014 Oct;3(4):123-9. doi: 10.4103/2279-042X.145387.
PubMed 25535620Mirkheshti A, Saadatniaki A, Salimi A, Manafi Rasi A, Memary E, Yahyaei H. Effects of dexmedetomidine versus ketorolac as local anesthetic adjuvants on the onset and duration of infraclavicular brachial plexus block. Anesth Pain Med. 2014 Aug 2;4(3):e17620. doi: 10.5812/aapm.17620. eCollection 2014 Aug.
PubMed 25237638Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.
PubMed 22012543Reinhart DJ, Stagg KS, Walker KG, Wang WP, Parker CM, Jackson HH, Walker EB. Postoperative analgesia after peripheral nerve block for podiatric surgery: clinical efficacy and chemical stability of lidocaine alone versus lidocaine plus ketorolac. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):506-13. doi: 10.1053/rapm.2000.7624.
PubMed 11009237Akhondzade R, Nesioonpour S, Gousheh M, Soltani F, Davarimoghadam M. The Effect of Magnesium Sulfate on Postoperative Pain in Upper Limb Surgeries by Supraclavicular Block Under Ultrasound Guidance. Anesth Pain Med. 2017 Jun 10;7(3):e14232. doi: 10.5812/aapm.14232. eCollection 2017 Jun.
PubMed 28924560
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of Adding Magnesium Sulfate Versus Ketorolac to Bupivacaine in Ultrasound-guided Supraclavicular Brachial Plexus Block (A Prospective- Double-blinded Randomized Controlled Trial)
- ClinicalTrials.gov ID
- NCT04554862
- Acronym / sponsor ID
- M419
- Conditions
- Postoperative Pain
- Keywords
- Magnesium, Ketorolac, Supraclavicular block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 18 Sep 2020 (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.
Despite many regional anesthetic techniques have been described for anesthesia of the brachial plexus which is responsible for the sensory and motor innervation of entire upper limb, still, supraclavicular block (SCB) is the regional anesthetic technique of choice.
SCB has been described as the spinal anesthesia of the upper limb as it offers dense anesthesia of the brachial plexus for the surgical procedures below the arm from elbow to hand. Although the SCB has a high incidence of complications like pneumothorax, the use of ultrasound-guided block improved the safety for the patient. There are several adjuvants have been added to SCB aiming for prolongation of the duration of peripheral nerve block as fentanyl, alpha 2 adrenergic agonist (Dexmedetomidine, Clonidine), tramadol, ketorolac and Magnesium sulfate.
Magnesium has anti-nociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells. Calcium influx leads to a sequence of central sensitization such as windup phenomenon and long term potentiation which are crucial mechanisms that determine the duration and intensity of post-operative pain. Magnesium prevents central sensitization triggered by peripheral nociceptive stimulation in response to painful stimuli.
Non-Steroidal Anti-Inflammatory drugs (NSAID) inhibit synthesis of prostaglandins from arachnoid acid in phospholipid membranes resulting in decreased afferent nociceptive signals from the site of surgery. There are a lot of studies supported the analgesic effect when NSAIDs are concentrated at a peripheral site compared to the systemic administration therapy. Ketorolac is a parenteral NSAIDs. Studies have shown that ketorolac as an adjuvant to local anesthetics during peripheral nerve block enhanced duration and quality of analgesia.
Detailed description
Eighty adult patients scheduled for upper limb surgeries from elbow to hand will be enrolled in the study after obtaining approval of the local institutional ethics committee and local institutional review board at Fayoum University Hospital. A detailed informed consent will be signed by the eligible participants before recruitment and randomization.
80 patients will be chosen to receive either Mg (group M, n=40) or ketorolac (group K, n=40) randomly by a computer-generated table. The randomization sequence will be concealed in opaque sealed envelopes. The envelopes will be opened by the study investigator just after recruitments and admission to the operation room. Only participants and care providers will be blinded to the group allocations. The consolidated standards of reporting trials (CONSORT) recommendations for reporting randomized, controlled clinical trials will be followed.
Patient preoperative preparations:
Preoperative investigations will be done according to the local protocol designed to evaluate the patients. It will include complete blood count, blood sugar level, serum urea and creatinine, liver function tests, coagulation profile, and ECG.
Before surgery, the participants will receive education about the (NRS) from (0-10 mm) (where 0=no pain and 10 = worst comprehensible pain) and the details of the nerve block procedures.
After a 6h fasting, the patients will be taken to the operating theatre.
Anesthetic technique:
A (20G) IV catheter will be placed in the UL opposite the surgical site after the arrival of the patient to the operating room. IV premedication will be administered to all patients (midazolam 0.02mg/kg and fentanyl 50mcg/dose). Supplemental oxygen (nasal cannula at 2L/min), and standard ASA monitoring (5-lead ECG, NIBP, and pulse oximetry) will be applied throughout the procedure.
Block technique
For the ultrasound-guided SCB, the patients will be placed in a supine position and the head turned slightly to the opposite side of their block. The injured hand will be put on the patient's abdomen and the shoulder will be moved downward as much as possible. The supraclavicular area will be cleaned using an antiseptic iodine solution and draped. Once the skin will be appropriately cleaned and prepared with anti-septic, the high-frequency linear array transducer will be placed over the supraclavicular area. After infiltration of the site by a local anesthetic, a sterile 22 gauge, 50 mm echogenic needle under ultrasound guidance will be inserted and after reaching the tip of the needle near the subclavian artery around the brachial plexus, the solution will be injected and the spread of the drug will be visualized. 25 ml of bupivacaine 0.5% + 6ml of magnesium sulfate 10% will be injected to group M and 25ml of bupivacaine 0.5% + 2ml of ketorolac 30mg + 4ml normal saline will injected to group K. The continuous aspiration and injection will be taken to avoid intravascular injection. After performing the block on the patients, hemodynamic parameters and all complications related to SCB (pneumothorax, hematoma, hypotension, bradycardia, etc.) will be recorded. After ensuring adequate anesthetic effect of the block, the surgery was started.
Assessment of sensory and motor blockade:
The extent of motor and sensory blockade will be evaluated by an anesthesiologist who will not be involved in the SCB 30 minutes. after local anesthetic administration. Using an alcohol swab, the sensory blockade will be tested by pin prick test using a 3- point scale:
Grade 0: normal sensation. Grade 1: decreased pain sensation to pinprick. Grade 2: loss of pain sensation to pinprick in the median, ulnar, radial and musculocutaneous nerve locations.
And it will be tested every 5 minutes for 30 minutes.
Motor blockade will be assessed by using (modified bromage) 3-point scale:
Grade 0: Normal motor function. Grade 1: Decreased motor strength with ability to move fingers only. Grade 2: Complete motor block. And it will be tested every 5 minutes for 30 minutes. When the operation was over, NRS score will be measured at 0, 1, 4, 8, 12, 24 hours.
Post-operative care:
Patients will be transferred to post-anesthetic care unit (PACU) for 2 hours. Then the patients will be discharged from the PACU.
Patient will receive analgesic according to the local institutional protocol as the following (Diclofenac sodium 75mg and paracetamol 1 gram by intravenous infusion over 30 minute.) as a component of multimodal anesthesia regimen for postoperative pain control.
Post-operative pain will be rated on (NRS) from 0 (no pain) to 10 (worst imaginable pain) at 1hr at PACU then at 4,8,12 and 24 hours postoperatively.
Patients with NRS>5 will receive morphine sulfate IV at a bolus dose of 2-5 mg increments with maximum dose of 20 mg at 4hours or 40mg at 24 hours. The morphine titration protocol will be suspended with Oxygen saturation < 95%; Respiratory rate < 10 / minute; the development of sedation (Ramsay sedation scale >2); development of acute adverse effects (allergy, marked itching, excessive vomiting, and hypotension with systolic blood pressure less than 20% of baseline values); or attaining adequate level of analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the intervention group (M) magnesium sulfate | Active comparator | Drug: Magnesium sulfate, Procedure: supraclavicular blocka 6ml of magnesium sulfate 10% (600mg) will be added to 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block |
| the intervention group (K) ketorolac | Active comparator | Drug: Ketorolac Tromethamine, Procedure: supraclavicular blocka 2ml of ketorolac (30mg) will be added to 4ml of normal saline and 25ml of bupivacaine 0.5% for supraclavicular brachial plexus block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status from I to III participants who were scheduled for surgical procedures of the arm from elbow to hand
Key exclusion criteria (8 listed)
- Patient refusal.
- Contraindication to regional anesthesia (coagulopathy, allergy to the local anesthetic or any adjuvants added, severe thrombocytopenia, pre-existing neuropathy in the operative limb, infection at puncture site).
- Sepsis.
- Pregnant or lactating women.
- Hepatic or renal dysfunction.
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 |
|---|---|---|
| Magnesium sulfateAlso: magnesium 10%magnesium sulfate will be added to the block | Drug | the intervention group (M) magnesium sulfate |
| Ketorolac TromethamineAlso: ketorolacketorolac will be added to the block | Drug | the intervention group (K) ketorolac |
| supraclavicular blockit is done by ultrasound- guided | Procedure or surgery | the intervention group (K) ketorolac, the intervention group (M) magnesium sulfate |
Primary outcome
the cumulative morphine consumption
Time frame: At 24 hours postoperative
In milligrams
17 secondary outcomes
numerical rating scale (NRS) of postoperative pain
Time frame: at 1 hour in the post-anesthesia care unit (PACU)
numerical rating scale (NRS) of postoperative pain
Time frame: at 4 hours postoperative
numerical rating scale (NRS) of postoperative pain
Time frame: at 8 hours postoperative
numerical rating scale (NRS) of postoperative pain
Time frame: at 12 hours postoperative
numerical rating scale (NRS) of postoperative pain
Time frame: at 24 hours postoperative
incidence of opioid related side-effects
Time frame: 5 minutes after supraclavicular block till discharge from PACU
incidence of adverse effects related to the block
Time frame: 5 minutes after supraclavicular block till discharge from PACU
time to the first requirement of analgesic supplement
Time frame: 5 minutes After supraclavicular block till first requirement of analgesic
Duration of surgical procedures
Time frame: 5 minutes after completion of surgical procedures
Assessment of heart rate
Time frame: from the start of the block till completion of surgical procedures
Assessment of mean blood pressure
Time frame: from the start of the block till completion of surgical procedures
Assessment of respiratory rate
Time frame: from the start of the block till completion of surgical procedures
Assessment of Oxygen saturation
Time frame: from the start of the block till completion of surgical procedures
Age
Time frame: 10 minutes before surgery
Weight
Time frame: 10 minutes before surgery
Height
Time frame: 10 minutes before surgery
Body mass index
Time frame: 10 minutes before surgery
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 5 Oct 2022.
- Background: PubMed 25535620Mukherjee K, Das A, Basunia SR, Dutta S, Mandal P, Mukherjee A. Evaluation of Magnesium as an adjuvant in Ropivacaine-induced supraclavicular brachial plexus block: A prospective, double-blinded randomized controlled study. J Res Pharm Pract. 2014 Oct;3(4):123-9. doi: 10.4103/2279-042X.145387.
- Background: PubMed 25237638Mirkheshti A, Saadatniaki A, Salimi A, Manafi Rasi A, Memary E, Yahyaei H. Effects of dexmedetomidine versus ketorolac as local anesthetic adjuvants on the onset and duration of infraclavicular brachial plexus block. Anesth Pain Med. 2014 Aug 2;4(3):e17620. doi: 10.5812/aapm.17620. eCollection 2014 Aug.
- Background: PubMed 22012543Lee AR, Yi HW, Chung IS, Ko JS, Ahn HJ, Gwak MS, Choi DH, Choi SJ. Magnesium added to bupivacaine prolongs the duration of analgesia after interscalene nerve block. Can J Anaesth. 2012 Jan;59(1):21-7. doi: 10.1007/s12630-011-9604-5. Epub 2011 Oct 20.
- Background: PubMed 11009237Reinhart DJ, Stagg KS, Walker KG, Wang WP, Parker CM, Jackson HH, Walker EB. Postoperative analgesia after peripheral nerve block for podiatric surgery: clinical efficacy and chemical stability of lidocaine alone versus lidocaine plus ketorolac. Reg Anesth Pain Med. 2000 Sep-Oct;25(5):506-13. doi: 10.1053/rapm.2000.7624.
- Background: PubMed 28924560Akhondzade R, Nesioonpour S, Gousheh M, Soltani F, Davarimoghadam M. The Effect of Magnesium Sulfate on Postoperative Pain in Upper Limb Surgeries by Supraclavicular Block Under Ultrasound Guidance. Anesth Pain Med. 2017 Jun 10;7(3):e14232. doi: 10.5812/aapm.14232. eCollection 2017 Jun.
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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.
Safaa G Ragab, MD principal investigator
Faculty of medicine, Fayoum university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Magnesium sulfate, Ketorolac Tromethamine and supraclavicular block in people with Postoperative Pain, run by Fayoum University Hospital 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 1 inclusion and 8 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 5 Oct 2022. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
the cumulative morphine consumption (time frame: At 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04554862, which also lists 5 linked publications.
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 5 Oct 2022.