Post Operative PainNCT05397236
Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block
A study testing Bupivacaine- Magnesium, Bupivacaine dexamethasone and Bupivacaine saline in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The goal of postoperative pain management is the provision of comfort, early mobilization and improved respiratory function without causing inadequate sedation and respiratory compromise, which can be achieved through using regional anethesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Bupivacaine- Magnesium, Bupivacaine dexamethasone and Bupivacaine saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2021to 1 Feb 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II
- aged 18 to 65 years
- body weight ≥ 60 kg and ≤ 90 kg
- scheduled for open abdominal surgeries
Who cannot join
- Patients' refusal to participate in the study
- history of allergy to the medications used in the study
- hepatic disease
- renal disease
- known neurologic disorders
- psychiatric disorder
Show all 13Show fewer
- chronic treatment with calcium channel blockers
- hyper-magnesemia
- coagulopathy
- anatomical abnormalities
- hemodynamic instability
- local infection
- suspected intra- abdominal sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between the Effect of Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block
The goal of postoperative pain management is the provision of comfort, early mobilization and improved respiratory function without causing inadequate sedation and respiratory compromise, which can be achieved through using regional anethesia.
This study aimed to assess the analgesic effect of adding dexamethasone or magnesium sulphate with bupivacaine in ultrasound-guided QLB to prolong its duration in patients undergoing open abdominal surgeries in the early postoperative period regarding pain relief After approval of the ethical committees in Ain Shams University Hospitals, patients undergoing open abdominal surgeries were included in the study, and were divided into three groups (n=22; each); group M, D and group C. In Group A, patients (n=22) received 20 ml bupivacaine 0.25% plus 5 ml of 10% MgSO. In group B, patients (n=22) received 20 ml bupivacaine 0.25% plus 8 mg dexamethasone (2 ml) plus 3 ml 0.9% NaCl. In group C (control), patients (n=22) received 20 ml bupivacaine plus 5 ml 0.9% NaCl.
- Conditions
- Post Operative Pain
- Being tested
- Bupivacaine- Magnesium, Bupivacaine dexamethasone, Bupivacaine saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine- MagnesiumDrug
Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4.
Bupivacaine dexamethasoneDrug
Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS.
Bupivacaine salineDrug
Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Magnesium sulphate group | Active comparator | Patients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4. Receives: Drug: Bupivacaine- Magnesium |
| Bupivacaine Dexamethasone group | Active comparator | Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS. Receives: Drug: Bupivacaine dexamethasone |
| bupivacaine saline group | Active comparator | Patients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS. Receives: Drug: Bupivacaine saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of post-operative analgesia
Time from completion of the block to the first request of rescue analgesia.
Measured: 24hours
Secondary outcomes (11)
Mean arterial blood pressure
Measured before induction of anesthesia (base line), upon arrival to the PACU, after 30 and 60 min. If hypotension (MBP < 20% of the base line value) occurred, 3 mg increments of ephedrine repeated every 5 min if required was given. MBP was then recorded at 2, 6, 12 and 24 post-operative hours.
Measured: 24 hours
Heart rate
Recorded before induction of anesthesia (base line),upon arrival to the PACU, after 30 and 60 min. If bradycardia (HR <50 bpm) occurred, 0.5 mg atropine was given. HR was then recorded at 2, 6, 12 and 24 post-operative hours.
Measured: 24 hours
The severity of post-operative pain at rest
By using the Visual Analogue Scale (VAS); from 0= no pain, to 10=worst imaginable pain. Assessed upon arrival to the PACU, after 30 and 60 min. The VAS was then recorded at 2, 4, 6, 8, 12 and 24 post-operative hours.
Measured: 24 hours
The severity of post-operative pain with movement (bilateral knee flexion)
By using the Visual Analogue Scale (VAS); from 0= no pain, to 10=worst imaginable pain. Assessed at 2, 4, 6, 8, 12 and 24 post-operative hours
Measured: 24 hours
Number of patients requiring post-operative rescue analgesia
Number of patients requiring pethidine in the 24 hours post-operative period
Measured: 24 hours
Total dose of pethidine given
The cumulative total pethidine doses given to each patient in the 24 hours post-operative period.
Measured: 24 hours
Occurrence of nausea and/or vomiting:
Number of patients who develop nausea and/or vomitting
Measured: 24 hours
Time to first ambulation
The time to the start of movement by each patient in the 24 hours post-operative period
Measured: 24 hours
The analgesic satisfaction at 24 post-operative hours
Patients were asked to report their satisfaction with the pain management; assessed as, 1 = poor, 2 = fair, 3 = good, and 4 = excellent.
Measured: 24 hours
Inadvertent femoral nerve block
number of patients who develop lower limb weakness
Measured: 24 hours
Local Anesthetic Systemic Toxicity (LAST):
As any regional anesthesia technique with local anesthetic is associated with potential systemic absorption of local anesthetics.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start1 Jun 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghada M.Samir, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05397236
- Sponsor's protocol ID
- FMASU MS 256/2021
- Status last verified
- May 2022
- First submitted
- 23 May 2022
- Last updated
- 31 May 2022
- Results posted
- No
- 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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between the Effect of Addition of MgSO4 or Dexamethasone to Bupivacaine on the Prolongation of Ultrasound-guided Quadratus Lumboram Block
- ClinicalTrials.gov ID
- NCT05397236
- Acronym / sponsor ID
- FMASU MS 256/2021
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 31 May 2022 (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.
The goal of postoperative pain management is the provision of comfort, early mobilization and improved respiratory function without causing inadequate sedation and respiratory compromise, which can be achieved through using regional anethesia.
This study aimed to assess the analgesic effect of adding dexamethasone or magnesium sulphate with bupivacaine in ultrasound-guided QLB to prolong its duration in patients undergoing open abdominal surgeries in the early postoperative period regarding pain relief After approval of the ethical committees in Ain Shams University Hospitals, patients undergoing open abdominal surgeries were included in the study, and were divided into three groups (n=22; each); group M, D and group C. In Group A, patients (n=22) received 20 ml bupivacaine 0.25% plus 5 ml of 10% MgSO. In group B, patients (n=22) received 20 ml bupivacaine 0.25% plus 8 mg dexamethasone (2 ml) plus 3 ml 0.9% NaCl. In group C (control), patients (n=22) received 20 ml bupivacaine plus 5 ml 0.9% NaCl.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Magnesium sulphate group | Active comparator | Drug: Bupivacaine- MagnesiumPatients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4. |
| Bupivacaine Dexamethasone group | Active comparator | Drug: Bupivacaine dexamethasonePatients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS. |
| bupivacaine saline group | Active comparator | Drug: Bupivacaine salinePatients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I or II
- aged 18 to 65 years
- body weight ≥ 60 kg and ≤ 90 kg
- scheduled for open abdominal surgeries
Key exclusion criteria (13 listed)
- Patients' refusal to participate in the study
- history of allergy to the medications used in the study
- hepatic disease
- renal disease
- known neurologic disorders
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 |
|---|---|---|
| Bupivacaine- MagnesiumPatients received QL block with 20 ml of 0.25% bupivacaine (2, 4)plus 5 ml of 10% MgSO4. | Drug | Bupivacaine Magnesium sulphate group |
| Bupivacaine dexamethasonePatients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 2 ml of 8 mg dexamethasone plus 3 ml of 0.9% NS. | Drug | Bupivacaine Dexamethasone group |
| Bupivacaine salinePatients received QL block with 20 ml of 0.25% bupivacaine (2,4)plus 5 ml of 0.9% NS. | Drug | bupivacaine saline group |
Primary outcome
Duration of post-operative analgesia
Time frame: 24hours
Time from completion of the block to the first request of rescue analgesia.
11 secondary outcomes
Mean arterial blood pressure
Time frame: 24 hours
Heart rate
Time frame: 24 hours
The severity of post-operative pain at rest
Time frame: 24 hours
The severity of post-operative pain with movement (bilateral knee flexion)
Time frame: 24 hours
Number of patients requiring post-operative rescue analgesia
Time frame: 24 hours
Total dose of pethidine given
Time frame: 24 hours
Occurrence of nausea and/or vomiting:
Time frame: 24 hours
Time to first ambulation
Time frame: 24 hours
The analgesic satisfaction at 24 post-operative hours
Time frame: 24 hours
Inadvertent femoral nerve block
Time frame: 24 hours
Local Anesthetic Systemic Toxicity (LAST):
Time frame: 24 hours
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 31 May 2022.
- 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 study testing Bupivacaine- Magnesium, Bupivacaine dexamethasone and Bupivacaine saline in people with Post Operative Pain, 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 4 inclusion and 13 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 31 May 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.
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?
Duration of post-operative analgesia (time frame: 24hours). 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 31 May 2022.