Post Operative PainPhase 1NCT05918796
Comparison Between Bupivacaine and Bupivacaine- Dexamethasone QLB for Postoperative Analgesia
A Phase 1 study testing Bupivacaine and Dexamethasone in people with Post Operative Pain, run by Ain Shams University at 1 site in Egypt.
Trial summary
The objective of this study is to assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Bupivacaine and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jun 2023to 1 Aug 2023
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients aging > 18 years of both sexes.
- Patients undergoing Laparoscopic cholecystectomy surgeries (duration of operation 50-80 minutes).
- ASA physical status classes I - II.
Who cannot join
- Patient's refusal of procedure or participation in the study.
- ASA classes III or above.
- Coagulopathy and bleeding disorders.
- Local skin infections
- Body mass index >40kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Quadratus Lumborum Block Using Bupivacaine Versus Bupivacaine - Dexamethasone as Postoperative Analgesia in Laparoscopic Cholecystectomy
The objective of this study is to assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.
Read the detailed description
Background: The QLB is an effective analgesic technique for various abdominal wall incisions. The QLB covers T7 to L2 dermatomes by the spread of LA drugs either into the paravertebral space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers.
Objective: To assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.
Patients and Methods: Sixty patients scheduled for elective Laparoscopic cholecystectomy surgeries under general anesthesia were included in this study, they were divided into two groups. Group A (perineural dexamethasone and bupivacaine group) [n=30] Those cases will receive 2ml volume of dexamethasone (8mg) combined with 18 ml of bupivacaine of 0.25% concentration. Group B (perineural bupivacaine group) [n=30] Those cases will receive perineural 18 ml bupivacaine (0.25%) combined with 2 ml normal saline.
- Conditions
- Post Operative Pain
- Being tested
- Bupivacaine, Dexamethasone
- Keywords
- bupivacaine, dexamethasone, quadratus lumborum block
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block
DexamethasoneDrug
dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Active comparator | ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2 ml normal saline bilaterally. Receives: Drug: Bupivacaine |
| bupivacaine and dexamethasone | Active comparator | ultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally. Receives: Drug: Bupivacaine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the time interval required till the first analgesic dose
to reach a numeric rating scale NRS Pain score ≥4
Measured: the first 24 hours
Secondary outcomes (4)
total pethidine dose received
record total dose of pethidine
Measured: total pethidine dose received in 24 hours
mean blood pressure
hemodynamics
Measured: will be recorded 5 minutes before injection, 5 minutes after injection then every 20 minutes intra-operatively and at intervals of 1, 2, 4, 6, 12, 18 and 24 hours postoperatively.
heart rate changes
hemodynamics
Measured: will be recorded 5 minutes before injection, 5 minutes after injection then every 20 minutes intra-operatively and at intervals of 1, 2, 4, 6, 12, 18 and 24 hours postoperatively.
Incidence of side effects
occurrence of nausea and vomiting
Measured: record any side effect over 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start15 Jun 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- rasha g abusinna, MD, Principal investigator, Faculty of medicine Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918796
- Sponsor's protocol ID
- Rasha Gamal Abusinna
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Quadratus Lumborum Block Using Bupivacaine Versus Bupivacaine - Dexamethasone as Postoperative Analgesia in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT05918796
- Acronym / sponsor ID
- Rasha Gamal Abusinna
- Conditions
- Post Operative Pain
- Keywords
- bupivacaine, dexamethasone, quadratus lumborum block
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 26 Jun 2023 (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 objective of this study is to assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.
Detailed description
Background: The QLB is an effective analgesic technique for various abdominal wall incisions. The QLB covers T7 to L2 dermatomes by the spread of LA drugs either into the paravertebral space or in the thoracolumbar plane, through iliohypogastric and ilioinguinal nerves, A and C fiber nociceptors, mechanoreceptors and high-density network of lumbar sympathetic fibers.
Objective: To assess the analgesic sparing effect of adding Dexamethasone to Bupivacaine in Quadratus lumborum block in patients undergoing Laparoscopic cholecystectomy under general anesthesia.
Patients and Methods: Sixty patients scheduled for elective Laparoscopic cholecystectomy surgeries under general anesthesia were included in this study, they were divided into two groups. Group A (perineural dexamethasone and bupivacaine group) [n=30] Those cases will receive 2ml volume of dexamethasone (8mg) combined with 18 ml of bupivacaine of 0.25% concentration. Group B (perineural bupivacaine group) [n=30] Those cases will receive perineural 18 ml bupivacaine (0.25%) combined with 2 ml normal saline.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Active comparator | Drug: Bupivacaineultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2 ml normal saline bilaterally. |
| bupivacaine and dexamethasone | Active comparator | Drug: Bupivacaine, Drug: Dexamethasoneultrasound guided quadratus lumborum perineural injection of 18 ml bupivacaine (0.25%) combined with 2ml volume of dexamethasone (8mg) bilaterally. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult patients aging > 18 years of both sexes.
- Patients undergoing Laparoscopic cholecystectomy surgeries (duration of operation 50-80 minutes).
- ASA physical status classes I - II.
Key exclusion criteria (5 listed)
- Patient's refusal of procedure or participation in the study.
- ASA classes III or above.
- Coagulopathy and bleeding disorders.
- Local skin infections
- Body mass index >40kg/m2
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 |
|---|---|---|
| Bupivacaine18 ml of bupivacaine of 0.25% injected bilaterally in quadratus lumborum block | Drug | bupivacaine, bupivacaine and dexamethasone |
| Dexamethasonedexamethasone | Drug | bupivacaine and dexamethasone |
Primary outcome
measuring the time interval required till the first analgesic dose
Time frame: the first 24 hours
to reach a numeric rating scale NRS Pain score ≥4
4 secondary outcomes
total pethidine dose received
Time frame: total pethidine dose received in 24 hours
mean blood pressure
Time frame: will be recorded 5 minutes before injection, 5 minutes after injection then every 20 minutes intra-operatively and at intervals of 1, 2, 4, 6, 12, 18 and 24 hours postoperatively.
heart rate changes
Time frame: will be recorded 5 minutes before injection, 5 minutes after injection then every 20 minutes intra-operatively and at intervals of 1, 2, 4, 6, 12, 18 and 24 hours postoperatively.
Incidence of side effects
Time frame: record any side effect over 24 hours
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 24 Aug 2023.
- 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.
rasha g abusinna, MD principal investigator
Faculty of medicine Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bupivacaine and Dexamethasone in people with Post Operative Pain, run by Ain Shams 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 5 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 24 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
measuring the time interval required till the first analgesic dose (time frame: the first 24 hours). 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 24 Aug 2023.