Postoperative PainNCT05261672
Regional Midazolam in Quadratus Lumborum Block
A study testing Midazolam/ bupivaciane and Bupivacain in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Midazolam has been used in regional anesthesia of brachial plexus block; it has offered accepted postoperative pain relief. This study will use it in as an adjuvant to bupivacaine 0.25% in quadratus lumborum block in caesarean section Read more about this study
- Who is it for?
- Ages 24 to 40 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Midazolam/ bupivaciane and Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2022to 20 Jan 2024
- 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 24 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II
- age from 24 to 40 years old
- weight from 50 to 80 kg,
- normal singleton pregnancy with a gestation of at least 37 weeks
Who cannot join
- Coagulopathy
- maternal anatomic abnormalities in the block region
- localized infection
- incapable of comprehending or using the verbal rating pain scoring system
- Included medications allergy
- history of chronic pain or regular opioid use.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Emad Zarief Kamel Said
Asyut, 71111
Emad Z Kamel, M.D., +201007046058, emadzarief@aun.edu.eg
About this study
Official title: Midazolam as an Adjuvant to Bupivacaine in Quadratus Lumborum Block After Caesarean Section; Does it Offer Better Pain Control? a Randomized Double Blind Clinical Trial
Midazolam has been used in regional anesthesia of brachial plexus block; it has offered accepted postoperative pain relief. This study will use it in as an adjuvant to bupivacaine 0.25% in quadratus lumborum block in caesarean section
Read the detailed description
It is vital to apply adequate postoperative analgesia following Caesarean section (C-section), since it will affect the distinct surgical recovery requirements of the parturient. The ultrasound-guided quadratus lumborum block (QLB), first introduced by Blanco R. in 2007, has been recognized as an effective abdominal wall block approach, in which local anesthetic injected from the posterior abdomen will spread around the quadratus lumborum muscle and block the intermuscular nerves. In addition, such block is also closely related to multiple sympathetic fibres and is connected to the thoracic paravertebral space. Typically, QLB is found to be effective, which can provide satisfactory analgesic effect.
Midazolam is one of the clinically water-soluble benzodiazepines and effective to produce the analgesic effect through the neuraxial pathways. The organs and joints of humans have the benzodiazepine receptor, and midazolam is revealed to produce the analgesic effect through the gamma-aminobutyric acid receptors (GABA) in the spinal cord. Previous studies have reported that the midazolam (75 μg/kg) through the intraarticular route can decrease the pain intensity for arthroscopic knee surgery. In addition, the intrathecal midazolam (2 mg) is reported to prolong the duration of analgesia without any adverse effects following knee arthroscopies. Perineural midazolam has been also evaluated in brachial plexus block.
- Conditions
- Postoperative Pain
- Being tested
- Midazolam/ bupivaciane, Bupivacain
- Keywords
- Midazolam, Bupivacaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midazolam/ bupivacianeDrug
20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side.
BupivacainDrug
20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side
| Study group | Role | What they receive |
|---|---|---|
| Group QL1 | Active comparator | quadratus lumborum block will be done. 20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side Receives: Drug: Bupivacain |
| Group QL2 | Active comparator | quadratus lumborum block will be done. ) 20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side. Receives: Drug: Midazolam/ bupivaciane |
What is being measured
The primary outcome is the main question the study is designed to answer.
rescue analgesia
Time to rescue analgesia in the post operative period
Measured: 24 hours
Secondary outcomes (1)
Visual analog scale
Pain Visual analog scale during the 1st 24 hours
Measured: 2, 4, 6, 8, 12, 16, 20, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start15 Mar 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion20 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Zarief , MD, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261672
- Sponsor's protocol ID
- IRB022022
- Status last verified
- Nov 2023
- First submitted
- 21 Feb 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
PubMed 26225500Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.
PubMed 28802593Tucker AP, Mezzatesta J, Nadeson R, Goodchild CS. Intrathecal midazolam II: combination with intrathecal fentanyl for labor pain. Anesth Analg. 2004 Jun;98(6):1521-1527. doi: 10.1213/01.ANE.0000112434.68702.E4.
PubMed 15155300Lefevre N, Klouche S, de Pamphilis O, Herman S, Gerometta A, Bohu Y. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study. Orthop Traumatol Surg Res. 2016 Nov;102(7):873-877. doi: 10.1016/j.otsr.2016.07.011. Epub 2016 Oct 4.
PubMed 27720193
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Midazolam as an Adjuvant to Bupivacaine in Quadratus Lumborum Block After Caesarean Section; Does it Offer Better Pain Control? a Randomized Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05261672
- Acronym / sponsor ID
- IRB022022
- Conditions
- Postoperative Pain
- Keywords
- Midazolam, Bupivacaine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 20 Jan 2024 (estimated)
- First posted
- 2 Mar 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.
Midazolam has been used in regional anesthesia of brachial plexus block; it has offered accepted postoperative pain relief. This study will use it in as an adjuvant to bupivacaine 0.25% in quadratus lumborum block in caesarean section
Detailed description
It is vital to apply adequate postoperative analgesia following Caesarean section (C-section), since it will affect the distinct surgical recovery requirements of the parturient. The ultrasound-guided quadratus lumborum block (QLB), first introduced by Blanco R. in 2007, has been recognized as an effective abdominal wall block approach, in which local anesthetic injected from the posterior abdomen will spread around the quadratus lumborum muscle and block the intermuscular nerves. In addition, such block is also closely related to multiple sympathetic fibres and is connected to the thoracic paravertebral space. Typically, QLB is found to be effective, which can provide satisfactory analgesic effect.
Midazolam is one of the clinically water-soluble benzodiazepines and effective to produce the analgesic effect through the neuraxial pathways. The organs and joints of humans have the benzodiazepine receptor, and midazolam is revealed to produce the analgesic effect through the gamma-aminobutyric acid receptors (GABA) in the spinal cord. Previous studies have reported that the midazolam (75 μg/kg) through the intraarticular route can decrease the pain intensity for arthroscopic knee surgery. In addition, the intrathecal midazolam (2 mg) is reported to prolong the duration of analgesia without any adverse effects following knee arthroscopies. Perineural midazolam has been also evaluated in brachial plexus block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group QL1 | Active comparator | Drug: Bupivacainquadratus lumborum block will be done. 20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side |
| Group QL2 | Active comparator | Drug: Midazolam/ bupivacianequadratus lumborum block will be done. ) 20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side. |
Who may qualify
- Ages
- 24 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- American Society of Anesthesiologists (ASA) physical status I or II
- age from 24 to 40 years old
- weight from 50 to 80 kg,
- normal singleton pregnancy with a gestation of at least 37 weeks
Key exclusion criteria (6 listed)
- Coagulopathy
- maternal anatomic abnormalities in the block region
- localized infection
- incapable of comprehending or using the verbal rating pain scoring system
- Included medications allergy
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 |
|---|---|---|
| Midazolam/ bupivaciane20 ml bupivacaine 0.25% will be injected + 2 mg midazolam in 1 ml saline on each side. | Drug | Group QL2 |
| Bupivacain20 ml bupivacaine 0.25% will be injected + 1 ml saline on each side | Drug | Group QL1 |
Primary outcome
rescue analgesia
Time frame: 24 hours
Time to rescue analgesia in the post operative period
1 secondary outcome
Visual analog scale
Time frame: 2, 4, 6, 8, 12, 16, 20, 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Results publication: PubMed 26225500Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
- Results publication: PubMed 28802593Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.
- Results publication: PubMed 15155300Tucker AP, Mezzatesta J, Nadeson R, Goodchild CS. Intrathecal midazolam II: combination with intrathecal fentanyl for labor pain. Anesth Analg. 2004 Jun;98(6):1521-1527. doi: 10.1213/01.ANE.0000112434.68702.E4.
- Results publication: PubMed 27720193Lefevre N, Klouche S, de Pamphilis O, Herman S, Gerometta A, Bohu Y. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study. Orthop Traumatol Surg Res. 2016 Nov;102(7):873-877. doi: 10.1016/j.otsr.2016.07.011. Epub 2016 Oct 4.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midazolam/ bupivaciane and Bupivacain in people with Postoperative Pain, run by Assiut 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 6 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 18 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emad Z Kamel, MD (+201007046058, emadzarief@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rescue analgesia (time frame: 24 hours). 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 NCT05261672, which also lists 4 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 18 Nov 2023.