AnalgesiaNCT04835415
Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy
A study testing Bilateral retrolaminar block and Thoracic epidural analgesia in people with Analgesia, run by Zagazig University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Bilateral retrolaminar block and Thoracic epidural analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2021to 1 Dec 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent from the patient.
- Age: 21-45 years old.
- Sex: both sex (males and females).
- Physical status: ASA 1\& II.
- BMI = (25-35 kg/m2).
- Type of operation: elective laparoscopic cholecystectomy
Who cannot join
- Altered mental state.
- Patients with known history of allergy to study drugs.
- Advanced hepatic, renal, cardiovascular, and respiratory diseases.
- Patients with chronic pain.
- Patients receiving anticoagulants.
- Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy
The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy.
Read the detailed description
To study the difference between the effects of ultrasound-guided bilateral retrolaminar block and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic cholecystectomy at Zagazig university hospitals.
- Conditions
- Analgesia
- Being tested
- Bilateral retrolaminar block, Thoracic epidural analgesia
- Keywords
- Ultrasound, Bilateral retrolaminar, Thoracic epidural, post operative analgesia, Laparoscopic cholecystectomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral retrolaminar blockProcedure or surgery
Also called Ultrasound guided retrolaminar block
in lateral position and after skin sterilization. The spine is palpated from cervical (C7) downward toT7 and point marked to identify the spinous process. The linear high frequency transducer (6-13 MHz) will be placed parasagittal plane 1 cm lateral to the midline. The needle (18 gauge) is inserted in the plane view of the ultrasound probe to target the T7 and needle is advanced from downward to upward until the needle tip contacted the lamina. After negative aspiration, a 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side.
Thoracic epidural analgesiaProcedure or surgery
Also called Ultrasound guided thoracic epidural
In the lateral position, after skin sterilization, Ultrasound with high frequency linear probe (5-13 MHz). Thoracic intervertebral space (T7-8) will be identified by counting from the C7 to prominent thoracic spine (T7). The probe will be used in parasagittal plane 2 cm from midline. The probe will be directed medially to identify the dura matter at the T7-8 intervertebral space . the needle 18 gauage will be inserted in plane to target T7-8 intervertebral space ., after needle tip reached target space, loss of resistance technique then 20 ml bupivacaine 0.25% plus 5ug/ml adrenaline (1:200000) was injected after aspiration
| Study group | Role | What they receive |
|---|---|---|
| group T | Active comparator | Group (T) (n=26): will receive ultrasound guided thoracic epidural analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000). Receives: Procedure: Thoracic epidural analgesia |
| group R | Active comparator | Group (R) (n=26): will receive bilateral ultrasound guided retrolaminar block analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000). Receives: Procedure: Bilateral retrolaminar block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Measured: 30 minutes postoperative
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Measured: at 1 hour postoperative
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Measured: at 2 hours postoperative
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Measured: at 4 hours postoperative
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Measured: at 6 hours postoperative
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Measured: at 8 hours postoperative
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Measured: at 10 hours postoperative
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Measured: at 12 hours postoperative
Secondary outcomes (5)
Time to first call of rescue analgesia
start from retrolaminar or epidural injection of the drug to the time of first call of naluphine
Measured: within 12 hours postoperative
Total analgesic (Naluphine) consumption
Total consumption of rescue analgesia(Naluphine) post operative
Measured: within 12 hours postoperative
The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)
The numer of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)
Measured: within 24 hours postoperative
Patient satisfaction is recorded at the end of 24 hours postoperative
using 5-point Likert-like verbal rating scale by asking the patient about "how he/she evaluated their experience with the analgesic management after the surgery?"5=very satisfied, 4=satisfied, 3= neutral, 2= dissatisfied and 1= very dissatisfied".
Measured: 24 hours postoperative
The number of participant with nausea, vomiting, hypotension and bradycardia.
the number of participant with nausea (sensation of being about to vomit), vomiting (the expelling of the food content from the stomach through mouth, it will be treated by 4 mg ondansetron), hypotension (if MAP decreases more than 20% of basal reading it will be treated by 12 mg ephedrine) and bradycardia (if HR less than 50 beats/min it will be treated by 0.5 mg atropine).
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start10 Apr 2021
- Primary completion15 Nov 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Model description
- Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dina Abdelhameed Elsadek Salem, Zagazig University
- Investigators
- Dina Salem, MD., Principal investigator, faculty of medicine , Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835415
- Sponsor's protocol ID
- 6777
- Status last verified
- Jan 2022
- First submitted
- 4 Apr 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT04835415
- Acronym / sponsor ID
- 6777
- Conditions
- Analgesia
- Keywords
- Ultrasound, Bilateral retrolaminar, Thoracic epidural, post operative analgesia, Laparoscopic cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 8 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 evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy.
Detailed description
To study the difference between the effects of ultrasound-guided bilateral retrolaminar block and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic cholecystectomy at Zagazig university hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia.
| Arm | Type | Receives |
|---|---|---|
| group T | Active comparator | Procedure: Thoracic epidural analgesiaGroup (T) (n=26): will receive ultrasound guided thoracic epidural analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000). |
| group R | Active comparator | Procedure: Bilateral retrolaminar blockGroup (R) (n=26): will receive bilateral ultrasound guided retrolaminar block analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000). |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent from the patient.
- Age: 21-45 years old.
- Sex: both sex (males and females).
- Physical status: ASA 1\& II.
- BMI = (25-35 kg/m2).
Key exclusion criteria (6 listed)
- Altered mental state.
- Patients with known history of allergy to study drugs.
- Advanced hepatic, renal, cardiovascular, and respiratory diseases.
- Patients with chronic pain.
- Patients receiving anticoagulants.
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 |
|---|---|---|
| Bilateral retrolaminar blockAlso: Ultrasound guided retrolaminar blockin lateral position and after skin sterilization. The spine is palpated from cervical (C7) downward toT7 and point marked to identify the spinous process. The linear high frequency transducer (6-13 MHz) will be placed parasagittal plane 1 cm lateral to the midline. The needle (18 gauge) is inserted in the plane view of the ultrasound probe to target the T7 and needle is advanced from downward to upward until the needle tip contacted the lamina. After negative aspiration, a 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side. | Procedure or surgery | group R |
| Thoracic epidural analgesiaAlso: Ultrasound guided thoracic epiduralIn the lateral position, after skin sterilization, Ultrasound with high frequency linear probe (5-13 MHz). Thoracic intervertebral space (T7-8) will be identified by counting from the C7 to prominent thoracic spine (T7). The probe will be used in parasagittal plane 2 cm from midline. The probe will be directed medially to identify the dura matter at the T7-8 intervertebral space . the needle 18 gauage will be inserted in plane to target T7-8 intervertebral space ., after needle tip reached target space, loss of resistance technique then 20 ml bupivacaine 0.25% plus 5ug/ml adrenaline (1:200000) was injected after aspiration | Procedure or surgery | group T |
Primary outcome
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Time frame: 30 minutes postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Time frame: at 1 hour postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Time frame: at 2 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Time frame: at 4 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Time frame: at 6 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Time frame: at 8 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Time frame: at 10 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Time frame: at 12 hours postoperative
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
5 secondary outcomes
Time to first call of rescue analgesia
Time frame: within 12 hours postoperative
Total analgesic (Naluphine) consumption
Time frame: within 12 hours postoperative
The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)
Time frame: within 24 hours postoperative
Patient satisfaction is recorded at the end of 24 hours postoperative
Time frame: 24 hours postoperative
The number of participant with nausea, vomiting, hypotension and bradycardia.
Time frame: 24 hours postoperative
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 27 Jan 2022.
- Individual participant dataSharing planned: No
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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.
Dina Salem, MD. principal investigator
faculty of medicine , Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bilateral retrolaminar block and Thoracic epidural analgesia in people with Analgesia, run by Zagazig 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 6 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 27 Jan 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?
Pain intensity at rest and at cough using Numerical Rating Scales (NRS) (time frame: 30 minutes postoperative). The study lists 8 primary outcomes in all. 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 27 Jan 2022.