Laparoscopic CholecystectomyNCT04845711
Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block in Laparoscopic Cholecystectomy
A study testing Erector spinae plane block group and Quadratus lumborum block group in people with Laparoscopic Cholecystectomy and Postoperative Analgesia, run by Tanta University.
Trial summary
The aim of this study is to compare between the efficacy of ultrasound guided erector spinae plane block and ultrasound guided quadratus lumborum block in managing acute postoperative pain in patients undergoing laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Analgesia, Erector Spinae Plane Block
- What is being tested?
- Erector spinae plane block group and Quadratus lumborum block group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Nov 2021
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 21-65 years
- both genders
- American Society of Anesthesiology (ASA) class I-II
- Undergoing elective laparoscopic cholecystectomy
Who cannot join
- Patient refusal.
- Coagulopathy.
- History of allergy to local anaesthetic.
- History of liver or renal pathology affecting drug elimination
- Mental dysfunction or cognitive disorders.
- Use of medication such as gabapentin-pregabalin that could affect pain perception.
- Body Mass Index > 40 kg/m2.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Surgeries: A Randomized Controlled Trial
The aim of this study is to compare between the efficacy of ultrasound guided erector spinae plane block and ultrasound guided quadratus lumborum block in managing acute postoperative pain in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Analgesia, Erector Spinae Plane Block, Quadratus Lumborum Block
- Being tested
- Control group, Erector spinae plane block group, Quadratus lumborum block group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control groupOther
Also called Group C
patients will receive general anesthesia only.
Erector spinae plane block groupProcedure or surgery
Also called group ESPB
patients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%)
Quadratus lumborum block groupProcedure or surgery
Also called group QLB
patients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%)
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | patients will receive general anesthesia only. Receives: Other: Control group |
| Erector spinae plane block group | Experimental | patients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%) Receives: Procedure: Erector spinae plane block group |
| Quadratus lumborum block group | Experimental | patients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%) Receives: Procedure: Quadratus lumborum block group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The degree of postoperative pain in the first 24 hours post-operative
Postoperative pain will be assessed by the numerical rating scale (NRS); 0 no pain while 10 is the maximum pain) after discharge to the ward ,and at 6, 12, 18, 24 hours.
Measured: first 24 hours post-operative
Secondary outcomes (3)
Time to first analgesic requirement
Intravenous morphine 2 mg will be given when the numerical rating scale (NRS) equal or above 4
Measured: first 24 hours post-operative
Total dose of intraoperative consumption of fentanyl
Fentanyl 0.5 μg/kg will be given if there was increase in heart rate or mean arterial blood pressure more than 20% (after exclusion of other causes than pain).
Measured: intraoperative
Total dose of rescue analgesia in the first 24hr postoperative
Total morphine consumption 24 hours after surgery will be recorded. Intravenous morphine 2 mg will be given when the numerical rating scale (NRS) equal or above 4
Measured: first 24 hours post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion31 Oct 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
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 Tanta 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
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsaid Hamada, Tanta University
- Investigators
- Mai E Hamada, MBBCH, Principal investigator, Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845711
- Sponsor's protocol ID
- 34503/2/21
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 15 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Erector Spinae Plane Block Versus Quadratus Lumborum Block for Postoperative Analgesia in Laparoscopic Cholecystectomy Surgeries: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04845711
- Acronym / sponsor ID
- 34503/2/21
- Conditions
- Laparoscopic Cholecystectomy, Postoperative Analgesia, Erector Spinae Plane Block, Quadratus Lumborum Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 15 Apr 2021 (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 compare between the efficacy of ultrasound guided erector spinae plane block and ultrasound guided quadratus lumborum block in managing acute postoperative pain in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: Control grouppatients will receive general anesthesia only. |
| Erector spinae plane block group | Experimental | Procedure: Erector spinae plane block grouppatients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%) |
| Quadratus lumborum block group | Experimental | Procedure: Quadratus lumborum block grouppatients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 21-65 years
- both genders
- American Society of Anesthesiology (ASA) class I-II
- Undergoing elective laparoscopic cholecystectomy
Key exclusion criteria (7 listed)
- Patient refusal.
- Coagulopathy.
- History of allergy to local anaesthetic.
- History of liver or renal pathology affecting drug elimination
- Mental dysfunction or cognitive 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 |
|---|---|---|
| Control groupAlso: Group Cpatients will receive general anesthesia only. | Other | Control group |
| Erector spinae plane block groupAlso: group ESPBpatients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%) | Procedure or surgery | Erector spinae plane block group |
| Quadratus lumborum block groupAlso: group QLBpatients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%) | Procedure or surgery | Quadratus lumborum block group |
Primary outcome
The degree of postoperative pain in the first 24 hours post-operative
Time frame: first 24 hours post-operative
Postoperative pain will be assessed by the numerical rating scale (NRS); 0 no pain while 10 is the maximum pain) after discharge to the ward ,and at 6, 12, 18, 24 hours.
3 secondary outcomes
Time to first analgesic requirement
Time frame: first 24 hours post-operative
Total dose of intraoperative consumption of fentanyl
Time frame: intraoperative
Total dose of rescue analgesia in the first 24hr postoperative
Time frame: first 24 hours post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2021.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request from the principal investigator
Related trials for Laparoscopic Cholecystectomy
Not yet recruitingPhase 4
Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
Airway Edema, Postoperative Complications
Not yet recruitingObservational study
Assessment of Optic Sheat Diameter (ONSD) and Eyeball Transverse Diameter (ETD) Ratio Measurement From Ocular Ultrasound
Optic Nerve Sheath Diameter Measurement, Intracranial Pressure Increase
Recruiting
US Guided EOI Block Versus ESPB for Postoperative Analgesia in Laparoscopic Cholecystectomy
Postoperative Pain
Enrolling by invitation
Heat Application and Shoulder Pillow for Post-Laparoscopic Shoulder Pain
Laparoscopic Cholecystectomy, Shoulder Pain
Active, not recruiting
Effect of Coffee Smelling on Pain, Physiological Parameters and Time to Discharge From Post Anesthesia Care Unit in Patients Undergoing Laparoscopic Cholecystectomy
Cholecystectomy, Laparoscopic
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.
Mai E Hamada, MBBCH principal investigator
Resident of Anesthesiology, Surgical Intensive Care and Pain Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Erector spinae plane block group and Quadratus lumborum block group in people with Laparoscopic Cholecystectomy and Postoperative Analgesia, run by Tanta University.
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 7 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 15 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Mai E Hamada, MBBCH (00201285851295, mai154450_pg@med.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The degree of postoperative pain in the first 24 hours post-operative (time frame: first 24 hours post-operative). 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 15 Apr 2021.