Postoperative PainNCT04167176
Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
A study testing Erector spinae plane block, Port site infiltration and Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China) in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing… 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?
- Erector spinae plane block, Port site infiltration and Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2020to 17 Sep 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
- Patients scheduled for elective laparoscopic cholecystectomy.
Who cannot join
- Allergy to local anaesthetics,
- Infection at the site of injection,
- •, Coagulopathy,
- Chronic pain syndromes,
- Prolonged opioid medication,
- Patients who received any analgesic 24 h before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.
- Conditions
- Postoperative Pain
- Being tested
- Erector spinae plane block, Port site infiltration, Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China), Bupivacaine 0.5%, Lidocaine 2%
- Keywords
- Cholecystectomy, ESP block, Port Site Infiltration
- 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 placed on their right side. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10-cm needle will be inserted using an in-plane approach in a cranial to caudal direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
Port site infiltrationProcedure or surgery
After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made.
Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)Device
Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.
Bupivacaine 0.5%Drug
Bupivacaine 0.5% will be included in the injected LA mixture.
Lidocaine 2%Drug
Lidocaine 2% will be included in the injected LA mixture.
| Study group | Role | What they receive |
|---|---|---|
| Erector spinae plane block | Active comparator | ultrasound guided ESP Block after anaesthesia induction Receives: Procedure: Erector spinae plane block; Device: Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China); Drug: Bupivacaine 0.5%; Drug: Lidocaine 2% |
| Port site infiltration technique | Active comparator | After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites Receives: Procedure: Port site infiltration; Drug: Bupivacaine 0.5%; Drug: Lidocaine 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total postoperative opioid consumption.
Nalbuphine consumption in mg.(equivalent to morphine dose)
Measured: 24 hours postoperatively
Secondary outcomes (5)
Pain scores;Numerical Rating Scale (NRS) at rest and when coughing
The NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which a respondent selects a whole number (0-10 integers).
Measured: at 1, 2,4 , 8, 16 and 24 hours postoperatively.
•Cumulative postoperative analgesic consumption
Analgesic drug consumption other than nalbuphine in mg.
Measured: 24 hours postoperatively
•Heart Rate (HR)
Heart Rate in beats /min
Measured: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
•Mean Arterial Pressure (MAP)
Mean Arterial Pressure in mmHg
Measured: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Incidence and severity Postoperative nausea & vomiting (PONV).
Number of patients developing PONV \& PONV Score; (1) No nausea or vomiting, (2) only nausea but no vomiting, (3) single episode of vomiting or persistent nausea, and (4) two or more episodes of vomiting or severe retching.
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 posted18 Nov 2019
- Study start15 Sep 2020
- Primary completion17 Sep 2022
- Study completion17 Sep 2022
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 44 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
- NCT04167176
- Sponsor's protocol ID
- ABC-3-DE
- Status last verified
- Dec 2022
- First submitted
- 6 Nov 2019
- Last updated
- 20 Dec 2022
- 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 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04167176
- Acronym / sponsor ID
- ABC-3-DE
- Conditions
- Postoperative Pain
- Keywords
- Cholecystectomy, ESP block, Port Site Infiltration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 17 Sep 2022 (actual)
- Study completion
- 17 Sep 2022 (actual)
- First posted
- 18 Nov 2019 (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 ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector spinae plane block | Active comparator | Procedure: Erector spinae plane block, Device: Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China), Drug: Bupivacaine 0.5%, Drug: Lidocaine 2%ultrasound guided ESP Block after anaesthesia induction |
| Port site infiltration technique | Active comparator | Procedure: Port site infiltration, Drug: Bupivacaine 0.5%, Drug: Lidocaine 2%After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of Local anesthetic (LA) mixture that will be divided equally between port sites |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients with the American Society of Anesthesiologists (ASA) physical status I/II,
- Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
- Patients scheduled for elective laparoscopic cholecystectomy.
Key exclusion criteria (6 listed)
- Allergy to local anaesthetics,
- Infection at the site of injection,
- •, Coagulopathy,
- Chronic pain syndromes,
- Prolonged opioid medication,
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 placed on their right side. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10-cm needle will be inserted using an in-plane approach in a cranial to caudal direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side. | Procedure or surgery | Erector spinae plane block |
| Port site infiltrationAfter the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made. | Procedure or surgery | Port site infiltration technique |
| Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection. | Device | Erector spinae plane block |
| Bupivacaine 0.5%Bupivacaine 0.5% will be included in the injected LA mixture. | Drug | Erector spinae plane block, Port site infiltration technique |
| Lidocaine 2%Lidocaine 2% will be included in the injected LA mixture. | Drug | Erector spinae plane block, Port site infiltration technique |
Primary outcome
Total postoperative opioid consumption.
Time frame: 24 hours postoperatively
Nalbuphine consumption in mg.(equivalent to morphine dose)
5 secondary outcomes
Pain scores;Numerical Rating Scale (NRS) at rest and when coughing
Time frame: at 1, 2,4 , 8, 16 and 24 hours postoperatively.
•Cumulative postoperative analgesic consumption
Time frame: 24 hours postoperatively
•Heart Rate (HR)
Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
•Mean Arterial Pressure (MAP)
Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery
Incidence and severity 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 20 Dec 2022.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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, Port site infiltration and Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China) 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 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: finished, as of the sponsor's last update on 20 Dec 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?
Total postoperative 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 20 Dec 2022.