Gallbladder InflammationPhase 4NCT01322061
Vitamin C Efficacy in Reducing Post Operative Pain
A Phase 4 study testing Ascorbic Acid in people with Gallbladder Inflammation, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Opioids are the corner stone in the treatment of post operative pain. Because of the several side effects of opiods, non-steroidal anti-inflammatory drugs are usually added postoperatively to decrease the total requirements of opioids. However, non steroidal anti-inflammatory drugs have side effects of their own. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Inflammation
- What is being tested?
- Ascorbic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteLebanon
- Study dates
- Nov 2010to Jul 2011
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both gender
- Between 18-75 years old
- ASA class I, II, or III
- Scheduled to undergo laparoscopic cholecystectomy
Who cannot join
- Intake of anti-inflammatory drug in the past 24 hr
- Allergy to morphine
- History of chemical dependence
- Chronic pain state
- Inability to use PCA pumps
- History of obstructive sleep apnea
Show all 9Show fewer
- History of severe asthma
- History of COPD
- History of gastroesophageal reflux disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of a Single Oral Dose (2g) of Vitamin C in Reducing Intensity of Pain and Opioids Consumption in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized, Double-blinded, Placebo-controlled Study
Opioids are the corner stone in the treatment of post operative pain. Because of the several side effects of opiods, non-steroidal anti-inflammatory drugs are usually added postoperatively to decrease the total requirements of opioids. However, non steroidal anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side effects when used on short-term basis, has been shown to have promising analgesic effects in chronic pain and acute pain relief following orthopedic surgeries.
The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C in reducing the intensity of pain and the consumption of opioids in patients undergoing laparoscopic cholecystectomy at AUB-MC.
Read more
All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in the study. Patients will be randomized into two groups to receive either single dose oral vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both the patients and the investigation team will be blinded to the type of intervention. Intraoperative anesthesia management will be similar for both groups. Postoperative pain control will be achieved with patient controlled analgesia via a patient controlled morphine pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C concentration will be determined for each patient.
Patients demographics will be obtained and compared between both groups. The differences in pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and patient satisfaction scales will be compared between the two groups with the Student-t test, the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak vitamin C plasma concentration will be correlated with the pain scores in each group using regression analysis.
This study will provide relevant information on whether a single dose (2g) of vitamin C can reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus eliminating their side effects in patients undergoing laparoscopic cholecystectomy.
- Conditions
- Gallbladder Inflammation
- Being tested
- Ascorbic Acid
- Keywords
- Gallbladder removal, acute cholecystitis, Laparoscopic cholecestectomy
- Medical subject headings
- Cholecystitis, Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ascorbic AcidDrug
Also called Redoxon, Vitamin C 1000mg, Bayer LSR912 MFD
Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Active comparator | Not described Receives: Drug: Ascorbic Acid |
| mirinda | Placebo comparator | Not described Receives: Drug: Ascorbic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
total morphine consumption
During their stay in the PACU (Post Anesthesia Care Unit), patients in both groups will be started on a morphine IV PCA pump that is programmed to deliver on patient's demand 1mg every 6 minutes with a total limit of 30mg every 4 hours for post operative relief.Patients will be followed up after discharge from PACU and morphine consumption will be recorded
Measured: total morphine consumption in 24 hours
Secondary outcomes (5)
sedation score on the Ramsey scale
Measured: Sedation score will be measured in PACU and up 24 hours upon discharge from PACU
incidence of nausea and vomiting
Nausea/Vomiting will be monitored using Verbal Rating Score (VRS). The number of vomiting episodes will be recorded. Episodes of vomiting occurring less than 5 min-apart will be considered as one episode.
Measured: Nausea and vomiting incidence will be monitored in PACU and up 24 hours upon discharge from PACU
Incidence of itching
Measured: Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU
patient satisfaction scale
Patient satisfaction scale measures the overall patient's satisfaction regarding the post-operative experience in terms of pain managment. The scale is divided into four main categories: Excellent, Good, Fair,Poor.
Measured: patient satisfaction scale will be measured in PACU and up 24 hours upon discharge from PACU
Pain score on the Visual Analog Scale
During their stay in the PACU, the incisional, visceral and shoulder pain intensity for each patient will be measured using Visual Analog Scale (VAS)and/or Verbal Rating Score.
Measured: Pain will be measured in PACU and up to 24 hours upon discharge from PACU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gallbladder InflammationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghassan Kanazi, American University of Beirut Medical Center
- Investigators
- Ghassan Kanazi, MD, Principal investigator, AUBMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322061
- Sponsor's protocol ID
- ANES.GK.06
- Other IDs
- AUBMC
- Status last verified
- Jan 2012
- First submitted
- 9 Mar 2011
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kanazi GE, El-Khatib MF, Yazbeck-Karam VG, Hanna JE, Masri B, Aouad MT. Effect of vitamin C on morphine use after laparoscopic cholecystectomy: a randomized controlled trial. Can J Anaesth. 2012 Jun;59(6):538-43. doi: 10.1007/s12630-012-9692-x. Epub 2012 Mar 9.
PubMed 22402954
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Single Oral Dose (2g) of Vitamin C in Reducing Intensity of Pain and Opioids Consumption in Patients Undergoing Laparoscopic Cholecystectomy. A Randomized, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01322061
- Acronym / sponsor ID
- ANES.GK.06
- Conditions
- Gallbladder Inflammation
- Keywords
- Gallbladder removal, acute cholecystitis, Laparoscopic cholecestectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 24 Mar 2011 (estimated)
- 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.
Opioids are the corner stone in the treatment of post operative pain. Because of the several side effects of opiods, non-steroidal anti-inflammatory drugs are usually added postoperatively to decrease the total requirements of opioids. However, non steroidal anti-inflammatory drugs have side effects of their own. Vitamin C, with virtually no side effects when used on short-term basis, has been shown to have promising analgesic effects in chronic pain and acute pain relief following orthopedic surgeries.
The investigators propose to assess the role of a prophylactic single dose (2g) of vitamin C in reducing the intensity of pain and the consumption of opioids in patients undergoing laparoscopic cholecystectomy at AUB-MC.
All eligible patients undergoing laparoscopic cholecystectomy at AUB-MC will be included in the study. Patients will be randomized into two groups to receive either single dose oral vitamin C (2g) (Study Group) or identically looking placebo capsules (Control Group). Both the patients and the investigation team will be blinded to the type of intervention. Intraoperative anesthesia management will be similar for both groups. Postoperative pain control will be achieved with patient controlled analgesia via a patient controlled morphine pump in both groups. At several time intervals and up to 24 hours postoperatively, the pain scores, morphine consumptions, nausea/vomiting scores, sedation scales, itching scales, and patient satisfaction scales will be obtained for all patients. Also, the peak vitamin C concentration will be determined for each patient.
Patients demographics will be obtained and compared between both groups. The differences in pain scores, morphine consumptions, nausea/vomiting scores, and sedation, itching, and patient satisfaction scales will be compared between the two groups with the Student-t test, the analysis of variance, the Fisher exact test, and the Kruskal-Wallis test. The peak vitamin C plasma concentration will be correlated with the pain scores in each group using regression analysis.
This study will provide relevant information on whether a single dose (2g) of vitamin C can reduce morphine requirements and non steroidal anti-inflammatory drugs need and thus eliminating their side effects in patients undergoing laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin C | Active comparator | Drug: Ascorbic Acid |
| mirinda | Placebo comparator | Drug: Ascorbic Acid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients of both gender
- Between 18-75 years old
- ASA class I, II, or III
- Scheduled to undergo laparoscopic cholecystectomy
Key exclusion criteria (9 listed)
- Intake of anti-inflammatory drug in the past 24 hr
- Allergy to morphine
- History of chemical dependence
- Chronic pain state
- Inability to use PCA pumps
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 |
|---|---|---|
| Ascorbic AcidAlso: Redoxon, Vitamin C 1000mg, Bayer LSR912 MFDEffervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery | Drug | Vitamin C, mirinda |
Primary outcome
total morphine consumption
Time frame: total morphine consumption in 24 hours
During their stay in the PACU (Post Anesthesia Care Unit), patients in both groups will be started on a morphine IV PCA pump that is programmed to deliver on patient's demand 1mg every 6 minutes with a total limit of 30mg every 4 hours for post operative relief.Patients will be followed up after discharge from PACU and morphine consumption will be recorded
5 secondary outcomes
sedation score on the Ramsey scale
Time frame: Sedation score will be measured in PACU and up 24 hours upon discharge from PACU
incidence of nausea and vomiting
Time frame: Nausea and vomiting incidence will be monitored in PACU and up 24 hours upon discharge from PACU
Incidence of itching
Time frame: Itching incidence will be measured in PACU and up 24 hours upon discharge from PACU
patient satisfaction scale
Time frame: patient satisfaction scale will be measured in PACU and up 24 hours upon discharge from PACU
Pain score on the Visual Analog Scale
Time frame: Pain will be measured in PACU and up to 24 hours upon discharge from PACU
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 9 Jan 2012.
- Derived from this study: PubMed 22402954Kanazi GE, El-Khatib MF, Yazbeck-Karam VG, Hanna JE, Masri B, Aouad MT. Effect of vitamin C on morphine use after laparoscopic cholecystectomy: a randomized controlled trial. Can J Anaesth. 2012 Jun;59(6):538-43. doi: 10.1007/s12630-012-9692-x. Epub 2012 Mar 9.
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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.
Ghassan Kanazi, MD principal investigator
AUBMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ascorbic Acid in people with Gallbladder Inflammation, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 4 inclusion and 9 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 9 Jan 2012. 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 Lebanon. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
total morphine consumption (time frame: total morphine consumption in 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01322061, which also lists 1 linked publication.
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 9 Jan 2012.