Elective Major Abdominal SurgeryNCT04541732
Postoperative Analgesia of Quadratus Lumborum Block Versus Epidural Block After Major Abdominal Surgeries
A study testing Thoracic epidural block, Ultrasound-guided bilateral quadratus lumborum block and Induction of general anaesthesia with propofol in people with Elective Major Abdominal Surgery, run by Mansoura University at 1 site in Egypt.
Trial summary
Acute postoperative pain is an important issue after major abdominal surgeries for which different analgesic modalities have been tried. Epidural analgesia is the recommended technique to relieve pain after major abdominal surgeries owing to the proved superior analgesia, reduction of opioid-related side effects as… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Elective Major Abdominal Surgery
- What is being tested?
- Thoracic epidural block, Ultrasound-guided bilateral quadratus lumborum block and Induction of general anaesthesia with propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 6 May 2019
- 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 20 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-III
Who cannot join
- Patient's refusal
- Significant cardiac, disease.
- Significant hepatic disease.
- Significant renal disease (serum creatinine ˃ 1.5 mg/dl).
- Patients with drug abuse
- Allergy to study medications
Show all 10Show fewer
- Mental disease
- Communication barrier.
- Coagulopathy.
- Local skin infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultra-sound Guided Bilateral Quadratus Lumborum Block Versus Epidural Block for Postoperative Analgesia After Major Abdominal Surgeries.
Acute postoperative pain is an important issue after major abdominal surgeries for which different analgesic modalities have been tried.
Epidural analgesia is the recommended technique to relieve pain after major abdominal surgeries owing to the proved superior analgesia, reduction of opioid-related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility. However, it is not without complications.
Quadratus lumborum block is an ultrasound-guided block that provides patients with both visceral and somatic blockade. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for analgesia after major abdominal surgeries.
Read the detailed description
The aim of this study is to detect the feasibility of ultra-sound guided bilateral quadratus lumborum block as a postoperative analgesic modality after major abdominal surgery in comparison to epidural block and its effects on total rescue analgesic requirements in the 1st postoperative 24hours, time to first analgesic request, pain VAS scores, intraoperative and postoperative hemodynamics and postoperative opioid-related side effects.
Under complete aseptic conditions, the patients will receive either thoracic epidural block or bilateral ultrasound-guided quadratus lumborum block after induction of general anaesthesia
- Conditions
- Elective Major Abdominal Surgery
- Being tested
- Thoracic epidural block, Ultrasound-guided bilateral quadratus lumborum block, Induction of general anaesthesia with propofol, Muscle Relaxant, Maintenance of general anaesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic epidural blockOther
Patients who will be subjected to epidural block will be placed in the lateral position then, after sterilization of the skin, 21 G spinal needle will be inserted at T9-T11 intervertebral spaces. The epidural space will be located using the loss of resistance to air technique and a mixture of bupivacaine 0.25% + 50 μ fentanyl targeting T6 level will be injected following induction of general anaesthesia.
Ultrasound-guided bilateral quadratus lumborum blockOther
Patients who will be subjected to major abdominal surgeries will be placed in a supine position with a pillow under their side to obtain an appropriate view of quadratus lumborum muscle. After sterilization of the skin and ultrasound-guided identification of the quadratus lumborum muscle, 20 ml bupivacaine 0.25% + 25μ fentanyl will be injected on each side following induction of general anaesthesia
Induction of general anaesthesia with propofolDrug
propofol: 1.5-2.5mg/Kg
Muscle RelaxantDrug
Atracurium : 0.5mg/Kg.
Maintenance of general anaesthesiaDrug
Sevoflurane 0.7-1.5 MAC in 40% oxygen
| Study group | Role | What they receive |
|---|---|---|
| Thoracic epidural block | Experimental | Patients will receive thoracic epidural block following induction of general anaesthesia Receives: Other: Thoracic epidural block; Drug: Induction of general anaesthesia with propofol; Drug: Muscle Relaxant; Drug: Maintenance of general anaesthesia |
| Bilateral quadratus lumborum block | Active comparator | Patients will receive Ultrasound-guided bilateral quadratus lumborum block following induction of general anaesthesia Receives: Other: Ultrasound-guided bilateral quadratus lumborum block; Drug: Induction of general anaesthesia with propofol; Drug: Muscle Relaxant; Drug: Maintenance of general anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative 24 hours cumulative rescue morphine consumption
Measured: For 24 hours after surgery
Secondary outcomes (10)
The duration of postoperative analgesia
time from performing epidural or quadratus lumborum block till the time for the first rescue morphine request
Measured: For 24 hours after surgery
Postoperative pain score at rest
Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)
Measured: For 24 hours after surgery
Postoperative pain score on movement
Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)
Measured: For 24 hours after surgery
Postoperative pain score on cough
Visual analogue scale to assess the severity of postoperative pain (0 mm for no pain and100 mm for worst imaginable pain)
Measured: For 24 hours after surgery
Systolic blood pressure
Measured: For 28 hours after induction of anesthesia
Diastolic blood pressure
Measured: For 28 hours after induction of anesthesia
Mean blood pressure
Measured: For 28 hours after induction of anesthesia
Heart rate
Measured: For 28 hours after induction of anesthesia
Degree of postoperative nausea and vomiting
Nausea will be measured using a numerical rating system (none= 0; mild= 1; moderate= 2; severe= 3). The number of vomiting episodes and the number of antiemetics received will be recorded
Measured: For 24 hours after surgery
Pruritis
Measured: For 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2020
- Study start1 Jan 2019
- Primary completion9 Apr 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- Single blind study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed A Ghanem, MD, Study director, Associate ProfessorMona A Hasheesh, MD, Study chair, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04541732
- Sponsor's protocol ID
- MS ∕18.06.187
- Status last verified
- Sep 2020
- First submitted
- 2 Sep 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-sound Guided Bilateral Quadratus Lumborum Block Versus Epidural Block for Postoperative Analgesia After Major Abdominal Surgeries.
- ClinicalTrials.gov ID
- NCT04541732
- Acronym / sponsor ID
- MS ∕18.06.187
- Conditions
- Elective Major Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 9 Apr 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 9 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.
Acute postoperative pain is an important issue after major abdominal surgeries for which different analgesic modalities have been tried.
Epidural analgesia is the recommended technique to relieve pain after major abdominal surgeries owing to the proved superior analgesia, reduction of opioid-related side effects as nausea, vomiting, pruritis and sedation, earlier recovery of bowel function and earlier ability for postoperative mobility. However, it is not without complications.
Quadratus lumborum block is an ultrasound-guided block that provides patients with both visceral and somatic blockade. It lessens the potential risks associated with neuraxial techniques, so it may represent a novel alternative approach for analgesia after major abdominal surgeries.
Detailed description
The aim of this study is to detect the feasibility of ultra-sound guided bilateral quadratus lumborum block as a postoperative analgesic modality after major abdominal surgery in comparison to epidural block and its effects on total rescue analgesic requirements in the 1st postoperative 24hours, time to first analgesic request, pain VAS scores, intraoperative and postoperative hemodynamics and postoperative opioid-related side effects.
Under complete aseptic conditions, the patients will receive either thoracic epidural block or bilateral ultrasound-guided quadratus lumborum block after induction of general anaesthesia
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single blind study
| Arm | Type | Receives |
|---|---|---|
| Thoracic epidural block | Experimental | Other: Thoracic epidural block, Drug: Induction of general anaesthesia with propofol, Drug: Muscle Relaxant, Drug: Maintenance of general anaesthesiaPatients will receive thoracic epidural block following induction of general anaesthesia |
| Bilateral quadratus lumborum block | Active comparator | Other: Ultrasound-guided bilateral quadratus lumborum block, Drug: Induction of general anaesthesia with propofol, Drug: Muscle Relaxant, Drug: Maintenance of general anaesthesiaPatients will receive Ultrasound-guided bilateral quadratus lumborum block following induction of general anaesthesia |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status I-III
Key exclusion criteria (10 listed)
- Patient's refusal
- Significant cardiac, disease.
- Significant hepatic disease.
- Significant renal disease (serum creatinine ˃ 1.5 mg/dl).
- Patients with drug abuse
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 |
|---|---|---|
| Thoracic epidural blockPatients who will be subjected to epidural block will be placed in the lateral position then, after sterilization of the skin, 21 G spinal needle will be inserted at T9-T11 intervertebral spaces. The epidural space will be located using the loss of resistance to air technique and a mixture of bupivacaine 0.25% + 50 μ fentanyl targeting T6 level will be injected following induction of general anaesthesia. | Other | Thoracic epidural block |
| Ultrasound-guided bilateral quadratus lumborum blockPatients who will be subjected to major abdominal surgeries will be placed in a supine position with a pillow under their side to obtain an appropriate view of quadratus lumborum muscle. After sterilization of the skin and ultrasound-guided identification of the quadratus lumborum muscle, 20 ml bupivacaine 0.25% + 25μ fentanyl will be injected on each side following induction of general anaesthesia | Other | Bilateral quadratus lumborum block |
| Induction of general anaesthesia with propofolpropofol: 1.5-2.5mg/Kg | Drug | Bilateral quadratus lumborum block, Thoracic epidural block |
| Muscle RelaxantAtracurium : 0.5mg/Kg. | Drug | Bilateral quadratus lumborum block, Thoracic epidural block |
| Maintenance of general anaesthesiaSevoflurane 0.7-1.5 MAC in 40% oxygen | Drug | Bilateral quadratus lumborum block, Thoracic epidural block |
Primary outcome
Postoperative 24 hours cumulative rescue morphine consumption
Time frame: For 24 hours after surgery
10 secondary outcomes
The duration of postoperative analgesia
Time frame: For 24 hours after surgery
Postoperative pain score at rest
Time frame: For 24 hours after surgery
Postoperative pain score on movement
Time frame: For 24 hours after surgery
Postoperative pain score on cough
Time frame: For 24 hours after surgery
Systolic blood pressure
Time frame: For 28 hours after induction of anesthesia
Diastolic blood pressure
Time frame: For 28 hours after induction of anesthesia
Mean blood pressure
Time frame: For 28 hours after induction of anesthesia
Heart rate
Time frame: For 28 hours after induction of anesthesia
Degree of postoperative nausea and vomiting
Time frame: For 24 hours after surgery
Pruritis
Time frame: For 24 hours after 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 9 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed A Ghanem, MD study director
Associate Professor
Mona A Hasheesh, MD study chair
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic epidural block, Ultrasound-guided bilateral quadratus lumborum block and Induction of general anaesthesia with propofol in people with Elective Major Abdominal Surgery, run by Mansoura 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 1 inclusion and 10 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 9 Sep 2020. 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?
Postoperative 24 hours cumulative rescue morphine consumption (time frame: For 24 hours after surgery). 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 9 Sep 2020.