Postoperative AnalgesiaNCT06078241
Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
A study testing Intravenous lidocaine infusion, Erector spinae plane block (ESPB) and Intravenous infusion of normal saline in people with Postoperative Analgesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure to remove stones from the kidney by a small puncture wound through the skin. Patients receiving lidocaine infusion had lower pain scores, reduced postoperative analgesic requirements and decreased intraoperative anesthetic requirements. Read more about this study
- Who is it for?
- Ages 21 to 55 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Intravenous lidocaine infusion, Erector spinae plane block (ESPB) and Intravenous infusion of normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 31 Oct 2024
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) score I-II..
- Body mass index < 35 kg/m2.
Who cannot join
- Patient's refusal.
- Known coagulopathy.
- Known peripheral neuropathy or neurological deficits.
- Chronic pain disorders.
- Known allergy to study drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Lidocaine Infusion Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure to remove stones from the kidney by a small puncture wound through the skin. Patients receiving lidocaine infusion had lower pain scores, reduced postoperative analgesic requirements and decreased intraoperative anesthetic requirements. Erector spinae plane block (ESPB) seems to be effective when compared with no block or a placebo block.
- Conditions
- Postoperative Analgesia
- Being tested
- Intravenous lidocaine infusion, Erector spinae plane block (ESPB), Intravenous infusion of normal saline, ESPB with normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous lidocaine infusionDrug
Intravenous lidocaine infusion
Erector spinae plane block (ESPB)Other
Unilateral erector spinae plane block
Intravenous infusion of normal salineOther
Intravenous infusion of normal saline
ESPB with normal salineOther
Unilateral ESPB with normal saline
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine infusion | Active comparator | Not described Receives: Drug: Intravenous lidocaine infusion |
| Erector spinae plane block (ESPB) | Active comparator | Not described Receives: Other: Erector spinae plane block (ESPB) |
| Intravenous infusion of normal saline and ESPB with normal saline | Placebo comparator | Not described Receives: Other: Intravenous infusion of normal saline; Other: ESPB with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first rescue analgesia
Time to first rescue analgesia
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 posted11 Oct 2023
- Study start1 Nov 2023
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ibrahim Mamdouh Esmat, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078241
- Sponsor's protocol ID
- FMASU MS 556/ 2023
- Status last verified
- Nov 2024
- First submitted
- 5 Oct 2023
- Last updated
- 26 Nov 2024
- 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 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine Infusion Versus Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT06078241
- Acronym / sponsor ID
- FMASU MS 556/ 2023
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 11 Oct 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.
Percutaneous nephrolithotomy (PCNL) is a minimally invasive procedure to remove stones from the kidney by a small puncture wound through the skin. Patients receiving lidocaine infusion had lower pain scores, reduced postoperative analgesic requirements and decreased intraoperative anesthetic requirements. Erector spinae plane block (ESPB) seems to be effective when compared with no block or a placebo block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine infusion | Active comparator | Drug: Intravenous lidocaine infusion |
| Erector spinae plane block (ESPB) | Active comparator | Other: Erector spinae plane block (ESPB) |
| Intravenous infusion of normal saline and ESPB with normal saline | Placebo comparator | Other: Intravenous infusion of normal saline, Other: ESPB with normal saline |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) score I-II..
- Body mass index < 35 kg/m2.
Key exclusion criteria (5 listed)
- Patient's refusal.
- Known coagulopathy.
- Known peripheral neuropathy or neurological deficits.
- Chronic pain disorders.
- Known allergy to study drugs
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 |
|---|---|---|
| Intravenous lidocaine infusionIntravenous lidocaine infusion | Drug | Intravenous lidocaine infusion |
| Erector spinae plane block (ESPB)Unilateral erector spinae plane block | Other | Erector spinae plane block (ESPB) |
| Intravenous infusion of normal salineIntravenous infusion of normal saline | Other | Intravenous infusion of normal saline and ESPB with normal saline |
| ESPB with normal salineUnilateral ESPB with normal saline | Other | Intravenous infusion of normal saline and ESPB with normal saline |
Primary outcome
Time to first rescue analgesia
Time frame: 24 hours postoperatively
Time to first rescue analgesia
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 26 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Postoperative Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Conditioned Open Label Placebo for Postoperative Pain Management
Pain, Postoperative
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 Intravenous lidocaine infusion, Erector spinae plane block (ESPB) and Intravenous infusion of normal saline in people with Postoperative Analgesia, 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 2 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 26 Nov 2024. 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. 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?
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 to first rescue analgesia (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 26 Nov 2024.