Postoperative PainNCT04635644
Ultrasound Guided ESP Block Versus Intrathecal Morphine for Postoperative Analgesia in Major HPB Surgery.
A study testing Erector Spinae Plane Block and Intrathecal morphine in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB) Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Erector Spinae Plane Block and Intrathecal morphine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2021to 15 Mar 2023
- 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
- Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
- patients with the American Society of Anesthesiologists (ASA) physical status I - II,
- Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour.
Who cannot join
- Patient's refusal
- Allergy or contraindications to the study drugs,
- Infection at the site of injection,
- Coagulopathy,
- Psychiatric disorders
- Severely co-morbid patients,
- Chronic pain syndromes,
- Prolonged opioid medication,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Erector Spinae Block Versus Intrathecal Morphine for Postoperative Analgesia in Major Hepatopancreaticobiliary Surgery
To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)
- Conditions
- Postoperative Pain
- Being tested
- Erector Spinae Plane Block, Intrathecal morphine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Also called ESP block
Patients will be turned into the prone position. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T8 spinous process. The erector spinae muscles will be identified superficial to the tip of the T8 transverse process. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine, a 21G 10 cm needle will be inserted using an in-plane approach in a cranial to caudal direction to contact the T8 transverse process. The location of the needle tip will be confirmed by hydrodissection with 2 mL of lidocaine 2% and visualizing linear fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of 0.25% Bupivacaine is injected will be injected at this point. The same procedure will be repeated for the opposite side.
Intrathecal morphineProcedure or surgery
Also called ITM
Patients will be placed on their right side. An intrathecal injection of morphine 200 μg (0.2 mL of morphine sulfate 1 mg/mL) diluted in 1.8 mL normal saline will be administered at the L3-L4 or L4-L5 level with a 25 G Whitacre spinal needle.
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Patients will receive Erector spinae plane block. Receives: Procedure: Erector Spinae Plane Block |
| Intrathecal morphine ITM | Active comparator | Patients will receive Intrathecal morphine. Receives: Procedure: Intrathecal morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative opioid consumption
Nalbuphine consumption in mg equivalent to morphine dose
Measured: 24 hours postoperatively
Secondary outcomes (6)
Nalbuphine consumption in mg
equivalent to morphine dose
Measured: at 8, 48, and 72 hours postoperatively.
Analgesic drug consumption other than nalbuphine
consumption in mg
Measured: at 8, 24, 48, and 72 hours postoperatively.
Numerical Rating Scale (NRS) at rest and when coughing
NRS is an 11-point (0=no pain and 10=worst pain)
Measured: at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively
Heart Rate
Heart Rate in beats /min
Measured: Intraoperatively
Mean Arterial Pressure
Mean Arterial Pressure in mmHg
Measured: Intraoperatively
Incidence of Postoperative nausea & vomiting (PONV)
Number of patients developing PONV
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start15 Nov 2021
- Primary completion15 Feb 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Mohammed Mahdy Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04635644
- Sponsor's protocol ID
- ABC-4-DE
- Status last verified
- May 2023
- First submitted
- 14 Nov 2020
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Block Versus Intrathecal Morphine for Postoperative Analgesia in Major Hepatopancreaticobiliary Surgery
- ClinicalTrials.gov ID
- NCT04635644
- Acronym / sponsor ID
- ABC-4-DE
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 19 Nov 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.
To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Active comparator | Procedure: Erector Spinae Plane BlockPatients will receive Erector spinae plane block. |
| Intrathecal morphine ITM | Active comparator | Procedure: Intrathecal morphinePatients will receive Intrathecal morphine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
- patients with the American Society of Anesthesiologists (ASA) physical status I - II,
- Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour.
Key exclusion criteria (8 listed)
- Patient's refusal
- Allergy or contraindications to the study drugs,
- Infection at the site of injection,
- Coagulopathy,
- Psychiatric 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 |
|---|---|---|
| Erector Spinae Plane BlockAlso: ESP blockPatients will be turned into the prone position. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T8 spinous process. The erector spinae muscles will be identified superficial to the tip of the T8 transverse process. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine, a 21G 10 cm needle will be inserted using an in-plane approach in a cranial to caudal direction to contact the T8 transverse process. The location of the needle tip will be confirmed by hydrodissection with 2 mL of lidocaine 2% and visualizing linear fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of 0.25% Bupivacaine is injected will be injected at this point. The same procedure will be repeated for the opposite side. | Procedure or surgery | Erector Spinae Plane Block |
| Intrathecal morphineAlso: ITMPatients will be placed on their right side. An intrathecal injection of morphine 200 μg (0.2 mL of morphine sulfate 1 mg/mL) diluted in 1.8 mL normal saline will be administered at the L3-L4 or L4-L5 level with a 25 G Whitacre spinal needle. | Procedure or surgery | Intrathecal morphine ITM |
Primary outcome
Cumulative opioid consumption
Time frame: 24 hours postoperatively
Nalbuphine consumption in mg equivalent to morphine dose
6 secondary outcomes
Nalbuphine consumption in mg
Time frame: at 8, 48, and 72 hours postoperatively.
Analgesic drug consumption other than nalbuphine
Time frame: at 8, 24, 48, and 72 hours postoperatively.
Numerical Rating Scale (NRS) at rest and when coughing
Time frame: at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively
Heart Rate
Time frame: Intraoperatively
Mean Arterial Pressure
Time frame: Intraoperatively
Incidence of Postoperative nausea & vomiting (PONV)
Time frame: 24 hours postoperatively
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 22 May 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.
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 Erector Spinae Plane Block and Intrathecal morphine 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 3 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 22 May 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?
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?
Cumulative opioid consumption (time frame: 24 hours postoperatively). 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 22 May 2023.