Post Operative PainPhase 2NCT05105997
Dexamethasone/ Erector Spinae Plane Block Analgesia in Laparoscopic Cholecystectomy
A Phase 2 study testing Dexamethasone/ Erector Spinae Plane Block and Erector Spinae Plane Block in people with Post Operative Pain, run by Assiut University.
Trial summary
Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Dexamethasone/ Erector Spinae Plane Block and Erector Spinae Plane Block
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Jul 2023
- Phase
- Phase 2
- 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
- Patients undergoing elective LC under general anesthesia, ASA status I-II, aged from 18 to 65 years old of both sex
Who cannot join
- Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
- Altered conscious level
- Pregnancy
- Body mass index (BMI > 35)
- Advanced hepatic or renal failure
- Chronic opioid consumption
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Dexamethasone as a Bupivacaine Adjuvant in Ultrasound-guided Erector Spinae Plane Block for Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Double-blind Study
Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain.
Read the detailed description
Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain in the early postoperative period. The most likely reason is sub-diaphragmatic irritation, which is transmitted by the phrenic nerve, causing referred pain in the C4 dermatome. Due to multiple sources of pain, multimodal analgesia approaches have been used in the perioperative period following LC.
- Conditions
- Post Operative Pain
- Being tested
- Dexamethasone/ Erector Spinae Plane Block, Erector Spinae Plane 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.
Dexamethasone/ Erector Spinae Plane BlockDrug
Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision
Erector Spinae Plane BlockDrug
Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision.
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone/ Erector Spinae Plane Block | Active comparator | Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision. Receives: Drug: Dexamethasone/ Erector Spinae Plane Block |
| Erector Spinae Plane Block | Placebo comparator | Patients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision. Receives: Drug: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of postoperative pain
Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study startDec 2022 (estimated)
- Primary completionJul 2023 (estimated)
- Study completionJul 2023 (estimated)
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 Assiut 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05105997
- Sponsor's protocol ID
- SM 10 2021
- Status last verified
- Sep 2022
- First submitted
- 23 Oct 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone as a Bupivacaine Adjuvant in Ultrasound-guided Erector Spinae Plane Block for Patients Undergoing Laparoscopic Cholecystectomy: a Randomized Double-blind Study
- ClinicalTrials.gov ID
- NCT05105997
- Acronym / sponsor ID
- SM 10 2021
- Conditions
- Post Operative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Jul 2023 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 3 Nov 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.
Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain.
Detailed description
Although considered a minimally invasive procedure, laparoscopic cholecystectomy (LC) frequently results in moderate to severe immediate postoperative pain. In addition to predominant visceral pain, nearly half of all patients suffer from shoulder pain in the early postoperative period. The most likely reason is sub-diaphragmatic irritation, which is transmitted by the phrenic nerve, causing referred pain in the C4 dermatome. Due to multiple sources of pain, multimodal analgesia approaches have been used in the perioperative period following LC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone/ Erector Spinae Plane Block | Active comparator | Drug: Dexamethasone/ Erector Spinae Plane BlockPatients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision. |
| Erector Spinae Plane Block | Placebo comparator | Drug: Erector Spinae Plane BlockPatients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective LC under general anesthesia, ASA status I-II, aged from 18 to 65 years old of both sex
Key exclusion criteria (6 listed)
- Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis)
- Altered conscious level
- Pregnancy
- Body mass index (BMI > 35)
- Advanced hepatic or renal failure
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 |
|---|---|---|
| Dexamethasone/ Erector Spinae Plane BlockPatients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and dexamethasone 15 minutes before skin incision | Drug | Dexamethasone/ Erector Spinae Plane Block |
| Erector Spinae Plane BlockPatients will receive bilateral Ultrasound-guided Erector Spinae Plane Block with bupivacaine and one ml of normal saline 15 minutes before skin incision. | Drug | Erector Spinae Plane Block |
Primary outcome
The intensity of postoperative pain
Time frame: 24 hours after surgery
Assessed by the verbal analog pain scale graded from 0 to 10 (0 = no pain, and 10 = the worst possible pain)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexamethasone/ Erector Spinae Plane Block and Erector Spinae Plane Block in people with Post Operative Pain, run by Assiut 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 1 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: status not confirmed, as of the sponsor's last update on 23 Sep 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Seham M Moeen, MD (01006386324 ext. 02, seham.moeen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intensity of postoperative pain (time frame: 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 23 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.