Postoperative PainNCT06535256
Compare Intraperitoneal Instillation of Bupivacaine+dexmedetomidine Versus Bupivacaine+dexamethasone on Postoperative Pain After Lap Cholecystectomy
A study testing bupivacaine with dexamethasone and bupivacaine with dexmedetomidine in people with Postoperative Pain, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- bupivacaine with dexamethasone and bupivacaine with dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients scheduled for laparoscopic cholecystectomy
- Age 18-60 years
- American Society of Anesthesiologists (ASA) physical status I-II
Who cannot join
- Patients with diabetes mellitus
- Allergy to the study drugs
- Patients on steroids
- Pregnant females
- Patients with cardiac, pulmonary, hepatic or renal disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intraperitoneal Instillation of Bupivacaine with Dexmedetomidine Versus Bupivacaine with Dexamethasone on Postoperative Pain After Laparoscopic Cholecystectomy
Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy
Read the detailed description
Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.
Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.
Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.
- Conditions
- Postoperative Pain
- Being tested
- bupivacaine with dexamethasone, bupivacaine with dexmedetomidine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bupivacaine with dexamethasoneCombination product
intra-peritoneal instillation of bupivacaine with dexamethasone (received 40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline).
bupivacaine with dexmedetomidineCombination product
intra-peritoneal instillation of bupivacaine with dexmedetomidine (received 40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml).
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine with dexamethasone | Active comparator | 40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline). Receives: Combination Product: bupivacaine with dexamethasone |
| bupivacaine with dexmedetomidine | Active comparator | 40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml). Receives: Combination Product: bupivacaine with dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence and severity of postoperative pain for 24 hours
using VAS pain score
Measured: severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jun 2024
- Primary completion10 Nov 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaher Zaki Zaher, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535256
- Sponsor's protocol ID
- Asw 917/5/24
- Status last verified
- Jul 2024
- First submitted
- 25 Jul 2024
- Last updated
- 11 Mar 2025
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intraperitoneal Instillation of Bupivacaine with Dexmedetomidine Versus Bupivacaine with Dexamethasone on Postoperative Pain After Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06535256
- Acronym / sponsor ID
- Asw 917/5/24
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 10 Nov 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 2 Aug 2024 (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.
Comparison of intraperitoneal instillation of bupivacaine with dexmedetomidine versus bupivacaine with dexamethasone on postoperative pain after laparoscopic cholecystectomy
Detailed description
Laparoscopy has become the preferred mode for many diagnostic and operative procedures. It has the advantage better cosmetic results, faster recovery, short post-operative hospital stays, and early resumption of normal activities. Post-laparoscopic pain results from stretching of the intra-abdominal cavity, peritoneal inflammation, and diaphragmatic irritation caused by residual carbon-dioxide in the peritoneal cavity is very annoying to the patients.
Although the severity of pain after a laparoscopic procedure is less compared to laparotomy, but it is acute and can lead to increased analgesic requirements and prolonged hospital stays.
Several studies have evaluated post-laparoscopic pain relief methods such as intravenous analgesics analgesic patches, steroids, and intra-peritoneal instillation of local anaesthetics alone or with additives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine with dexamethasone | Active comparator | Combination Product: bupivacaine with dexamethasone40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline). |
| bupivacaine with dexmedetomidine | Active comparator | Combination Product: bupivacaine with dexmedetomidine40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients scheduled for laparoscopic cholecystectomy
- Age 18-60 years
- American Society of Anesthesiologists (ASA) physical status I-II
Key exclusion criteria (5 listed)
- Patients with diabetes mellitus
- Allergy to the study drugs
- Patients on steroids
- Pregnant females
- Patients with cardiac, pulmonary, hepatic or renal 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 |
|---|---|---|
| bupivacaine with dexamethasoneintra-peritoneal instillation of bupivacaine with dexamethasone (received 40 mL of 0.25% bupivacaine + 16 mg dexamethasone with 5 ml normal saline). | Combination product | bupivacaine with dexamethasone |
| bupivacaine with dexmedetomidineintra-peritoneal instillation of bupivacaine with dexmedetomidine (received 40 mL of 0.25% bupivacaine + dexmedetomidine 1 μg/kg with normal saline 5 ml). | Combination product | bupivacaine with dexmedetomidine |
Primary outcome
incidence and severity of postoperative pain for 24 hours
Time frame: severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale
using VAS pain score
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 11 Mar 2025.
- 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.
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 bupivacaine with dexamethasone and bupivacaine with dexmedetomidine in people with Postoperative Pain, run by Aswan University Hospital 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 11 Mar 2025. 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?
incidence and severity of postoperative pain for 24 hours (time frame: severity of postoperative pain measured at 1, 2, 4, 8, 16, and 24 hours. postoperatively, using Visual Analogue Scale). 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 11 Mar 2025.