Laparoscopic CholecystectomyNCT04064138
Analgesic Effect of Erector Spinea Plane Block Compared to Peritoneal Block in Laparoscopic Cholecystectomy
A study testing Peritoneal block, Ultrasound guided erector spinae plane block and General anesthesia in people with Laparoscopic Cholecystectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
The aim of this study is to detect weather peritoneal block or erector spinae plane block will provide the most ideal analgesia for patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- Peritoneal block, Ultrasound guided erector spinae plane block and General anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2019to 1 Oct 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American physical status classes I and II
Who cannot join
- Patient refusal.
- Pregnancy
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases.
- Bleeding diseases.
- Coagulation abnormality.
Show all 16Show fewer
- Psychiatric diseases.
- Local skin infection at site of the block.
- Local skin sepsis at site of the block.
- Known intolerance to the study drugs.
- Body Mass Index > 40 Kg/m2.
- Chronic renal disease.
- Chronic hepatic disease.
- Preexisting neurological deficit.
- Conversion to open cholecystectomy
- Excessively long surgical times (> 90 min)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University, Central Hospital, gastroenterology surgery centre
Al Mansurah, DK, 050
About this study
Official title: Erector Spinea Plane Block Versus Peritoneal Block Analgesia in Laparoscopic Cholecystectomy
The aim of this study is to detect weather peritoneal block or erector spinae plane block will provide the most ideal analgesia for patients undergoing laparoscopic cholecystectomy. Peritoneal block by instillation of local anesthetic into the peritoneal cavity will act by blocking the free afferent nerve endings in the peritoneum and the systemic absorption of local anesthetic from the peritoneal cavity may also play a part in reduced pain.
On the other hand ,the erector spinae plane block is a novel analgesic technique that provide both visceral and somatic analgesia due to its communication with the paravertebral space. Local anesthetic mixture of lidocaine , magnesium sulphate and epinephrine will be used for both techniques.
Read the detailed description
The pain that a patient feels after laparoscopic cholecystectomy results from three different and clinically separate components: somatic pain due to trocar insertion sites , visceral pain due to surgical dissection and tissue handling at the gall bladder bed, and shoulder pain due to retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm. Ineffective treatment of post laparoscopic cholecystectomy pain may delay recovery and mandate inpatient admission and therapy and increase the cost of such care.
The aim of this study is to evaluate the analgesic effect of Erector spinea plane block in comparison with peritoneal block for laparoscopic cholecystectomy. Serum level of cortisol as a stress biomarker ,perioperative primary hemodynamics ,visual analogue scale , patient request for rescue analgesia and occurrence of side effects are the parameters for comparison between both techniques. Each patient will be followed up for 24 hours postoperatively.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- Peritoneal block, Ultrasound guided erector spinae plane block, General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal blockProcedure or surgery
At the beginning of surgery, immediately after insertion of the first port 2 mg/kg lidocaine and 25mg/kg magnesium sulfate and 1/200 000 epinephrine in a total volume 50 ml (completed with saline .9%) will be given intra-peritoneal 10 min before the surgeon proceeds . At the end of the surgery another similar lidocaine-magnesium-epinephrine injection will be instillated before removal of the last port and the drain will be kept closed for 30 min.
Ultrasound guided erector spinae plane blockProcedure or surgery
Before general anesthesia, ESPB will be performed under ultrasound guidance. The linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. The patient's skin will be anesthetized with 3 mL of 2% lidocaine. A 21 gauge 10cm needle will be inserted using an in plane superior to inferior. The tip of the needle will be placed into the facial plane on the deep aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process on ultrasonographical imaging. The calculated dose of lidocaine (2mg/kg) with 150 mg MgSo4 and 1/200 000 epinephrine will be injected on each side.
General anesthesiaOther
General anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Peritoneal block | Active comparator | patients will receive peritoneal block as an adjuvant analgesic technique. Receives: Procedure: Peritoneal block; Other: General anesthesia |
| Ultrasound guided erector spinae plane block | Active comparator | Patients will receive ultrasound guided erector spinae plane block Receives: Procedure: Ultrasound guided erector spinae plane block; Other: General anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first requirement of rescue analgesia
an analgesic (nalbuphine 10 mg ) will be administer postoperatively on patient request in case of the pain score ≥ 4/10 on VAS. It represent the end point of the study which determines the duration of analgesia
Measured: for 24 hours after surgery
Secondary outcomes (13)
Peripheral oxygen saturation
estimate of oxygenated hemoglobin concentration in the blood , measured by pulse oximeter device
Measured: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
mean arterial blood pressure
The average pressure in the arteries during one cardiac cycle.
Measured: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
heart rate
Number of heart beats per minute. Lower heart rate implies better cardiovascular fitness and less stress.
Measured: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
end tidal CO2
amount of carbon dioxide in each breathe .
Measured: immediately after intubation and ever 10 min till the end of surgery.
Intensity of Abdominal Pain: visual analogue scale
Postoperative assessment of abdominal pain using visual analogue scale (1-10), where 1 equals no pain and 10 indicates the worst possible pain.
Measured: immediately after recovery ,then every 4 hours for 24 hour.
Intensity of Shoulder Pain: five point scale
shoulder pain score scale:
- no pain( the best outcome)
- discomfort in shoulder but no pain
- light pain ( analgesia not required)
- moderate pain ( analgesia required)
- sever pain ( analgesia and sedation required ) (the worst outcome)
Measured: immediately after recovery ,then every 4 hours for 24 hour.
serum cortisol level
a steroid hormone secreted from adrenal cortex in response to stress.
Measured: preoperative and one hour postoperative.
Post-operative total analgesic requirement
total amount of nalbuphine consumed by the patient from the time of first analgesic requirement till the end of 24 hours.
Measured: for 24 hours postoperatively.
nausea
four point verbal rating score to assess the incidence of nausea and vomiting where 1 indicate they did not happen , 2 indicate nausea and 3 indicate vomiting for once and 4 indicate repeated vomiting
Measured: immediately after recovery and every 4 hours for 24 hour postoperatively
vomiting
four point verbal rating score to assess the incidence of nausea and vomiting where 1 indicate they did not happen , 2 indicate nausea and 3 indicate vomiting for once and 4 indicate repeated vomiting.
Measured: immediately after recovery and every 4 hours for 24 hour postoperatively
dizziness
a questionnaire will be collected to detect the incidence of occurrence of dizziness
Measured: immediately after recovery and every 4 hours for 24 hour postoperatively
tinitus
a questionnaire will be collected to detect the incidence of occurrence of tinnitus
Measured: immediately after recovery and every 4 hours for 24 hour postoperatively
circumoral numbness
a questionnaire will be collected to detect the incidence of occurrence of circumoral numbness
Measured: immediately after recovery and every 4 hours for 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start1 Jul 2019
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammed A Sultan, MD, Study chair, Professor of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064138
- Sponsor's protocol ID
- MS ∕ 19.01.436
- Status last verified
- Dec 2019
- First submitted
- 12 Jul 2019
- Last updated
- 4 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 1. individual participant data will be available. 2. all individual participant data collected during the trial after deidentification will be shared. 3. The data will be shared with anyone who wishes to access the data for any purpose .
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinea Plane Block Versus Peritoneal Block Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04064138
- Acronym / sponsor ID
- MS ∕ 19.01.436
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 21 Aug 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.
The aim of this study is to detect weather peritoneal block or erector spinae plane block will provide the most ideal analgesia for patients undergoing laparoscopic cholecystectomy. Peritoneal block by instillation of local anesthetic into the peritoneal cavity will act by blocking the free afferent nerve endings in the peritoneum and the systemic absorption of local anesthetic from the peritoneal cavity may also play a part in reduced pain.
On the other hand ,the erector spinae plane block is a novel analgesic technique that provide both visceral and somatic analgesia due to its communication with the paravertebral space. Local anesthetic mixture of lidocaine , magnesium sulphate and epinephrine will be used for both techniques.
Detailed description
The pain that a patient feels after laparoscopic cholecystectomy results from three different and clinically separate components: somatic pain due to trocar insertion sites , visceral pain due to surgical dissection and tissue handling at the gall bladder bed, and shoulder pain due to retention of carbon dioxide in the abdomen, which irritates the phrenic nerve and diaphragm. Ineffective treatment of post laparoscopic cholecystectomy pain may delay recovery and mandate inpatient admission and therapy and increase the cost of such care.
The aim of this study is to evaluate the analgesic effect of Erector spinea plane block in comparison with peritoneal block for laparoscopic cholecystectomy. Serum level of cortisol as a stress biomarker ,perioperative primary hemodynamics ,visual analogue scale , patient request for rescue analgesia and occurrence of side effects are the parameters for comparison between both techniques. Each patient will be followed up for 24 hours postoperatively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peritoneal block | Active comparator | Procedure: Peritoneal block, Other: General anesthesiapatients will receive peritoneal block as an adjuvant analgesic technique. |
| Ultrasound guided erector spinae plane block | Active comparator | Procedure: Ultrasound guided erector spinae plane block, Other: General anesthesiaPatients will receive ultrasound guided erector spinae plane block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- American physical status classes I and II
Key exclusion criteria (16 listed)
- Patient refusal.
- Pregnancy
- Neuromuscular diseases (as myopathies, myasthenia gravies…)
- Hematological diseases.
- Bleeding diseases.
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 |
|---|---|---|
| Peritoneal blockAt the beginning of surgery, immediately after insertion of the first port 2 mg/kg lidocaine and 25mg/kg magnesium sulfate and 1/200 000 epinephrine in a total volume 50 ml (completed with saline .9%) will be given intra-peritoneal 10 min before the surgeon proceeds . At the end of the surgery another similar lidocaine-magnesium-epinephrine injection will be instillated before removal of the last port and the drain will be kept closed for 30 min. | Procedure or surgery | Peritoneal block |
| Ultrasound guided erector spinae plane blockBefore general anesthesia, ESPB will be performed under ultrasound guidance. The linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. The patient's skin will be anesthetized with 3 mL of 2% lidocaine. A 21 gauge 10cm needle will be inserted using an in plane superior to inferior. The tip of the needle will be placed into the facial plane on the deep aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process on ultrasonographical imaging. The calculated dose of lidocaine (2mg/kg) with 150 mg MgSo4 and 1/200 000 epinephrine will be injected on each side. | Procedure or surgery | Ultrasound guided erector spinae plane block |
| General anesthesiaGeneral anesthesia | Other | Peritoneal block, Ultrasound guided erector spinae plane block |
Primary outcome
Time for first requirement of rescue analgesia
Time frame: for 24 hours after surgery
an analgesic (nalbuphine 10 mg ) will be administer postoperatively on patient request in case of the pain score ≥ 4/10 on VAS. It represent the end point of the study which determines the duration of analgesia
13 secondary outcomes
Peripheral oxygen saturation
Time frame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
mean arterial blood pressure
Time frame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
heart rate
Time frame: one hour before induction general anesthesia then every 10 min till end of surgery then every 4 hours till end of first 24 hours.
end tidal CO2
Time frame: immediately after intubation and ever 10 min till the end of surgery.
Intensity of Abdominal Pain: visual analogue scale
Time frame: immediately after recovery ,then every 4 hours for 24 hour.
Intensity of Shoulder Pain: five point scale
Time frame: immediately after recovery ,then every 4 hours for 24 hour.
serum cortisol level
Time frame: preoperative and one hour postoperative.
Post-operative total analgesic requirement
Time frame: for 24 hours postoperatively.
nausea
Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively
vomiting
Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively
dizziness
Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively
tinitus
Time frame: immediately after recovery and every 4 hours for 24 hour postoperatively
circumoral numbness
Time frame: immediately after recovery and every 4 hours for 24 hour 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 4 Sep 2020.
- Individual participant dataSharing planned: Yes. 1. individual participant data will be available. 2. all individual participant data collected during the trial after deidentification will be shared. 3. The data will be shared with anyone who wishes to access the data for any purpose .
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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 Sultan, MD study chair
Professor of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal block, Ultrasound guided erector spinae plane block and General anesthesia in people with Laparoscopic Cholecystectomy, 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 16 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 4 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?
Time for first requirement of rescue analgesia (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 4 Sep 2020.