Laparoscopic CholecystectomyNCT00950625
Intraperitoneal Analgesia After Laparoscopic Cholecystectomy
A study testing lignocaine and bupevacaine in people with Laparoscopic Cholecystectomy, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- lignocaine and bupevacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- Aug 2009to Aug 2010
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy
- Elective surgical procedure
- American Society of Anesthesiologists class I and II
Who cannot join
- Patients refusing randomization
- Patients already on analgesics
- Patients with acute cholecystitis
- Patients requiring preoperative cholangiogram or common bile duct exploration
- Patients having bile or stone spillage during procedure
- Patients requiring conversion to open procedure
- Patients requiring re-exploration for any reason
- Patients with history of allergy to local anesthetic agents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. This postoperative pain is a major concern not only for the patients, but also healthcare workers; and it often contributes to overnight hospital stay after this minimally invasive surgical procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to control pain after laparoscopic cholecystectomy has been extensively studied in numerous randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two commonly used local anesthetic agents. In view of contradictory results from previous studies, it is not yet clear which of these two agents is superior to the other for pain control in this setting. To answer this question, we have designed a prospective randomized controlled trial and the specific aim of the study is to compare the analgesic efficacy of intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting after laparoscopic cholecystectomy.
If we can improve pain control after this minimally invasive procedure, it might result in decreased postoperative requirement of narcotic analgesia and its associated side-effects. It may also result in early recovery and the same day discharge of the patients with significant cost-containment for the patient and healthcare systems in future.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- lignocaine, bupevacaine
- Keywords
- intraperitoneal analgesia, laparoscopic cholecystectomy, lignocaine, bupevacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lignocaineDrug
200 mg of intraperitoneal lignocaine will be given once during surgery
bupevacaineDrug
100 mg of bupevacaine will be given once during laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| intraperitoneal lignocaine | Active comparator | Intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy Receives: Drug: lignocaine; Drug: bupevacaine |
| intraperitoneal bupevacaine | Active comparator | intraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy Receives: Drug: lignocaine; Drug: bupevacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Control after Laparoscopic Cholecystectomy
Measured: 24 hours after surgery
Secondary outcomes (1)
Requirement of Analgesia after laparoscopic cholecystectomy
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 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic CholecystectomyStudies 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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Investigators
- Muhammad R Khan, FRCS, Principal investigator, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950625
- Sponsor's protocol ID
- 091026SUR
- Status last verified
- Jul 2009
- First submitted
- 31 Jul 2009
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy of Intra-peritoneal Lignocaine With Bupivacaine After Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00950625
- Acronym / sponsor ID
- 091026SUR
- Conditions
- Laparoscopic Cholecystectomy
- Keywords
- intraperitoneal analgesia, laparoscopic cholecystectomy, lignocaine, bupevacaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Aug 2009 (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.
Although laparoscopic cholecystectomy is associated with less pain than contemporary open procedures; it is definitely not pain free and the magnitude of postoperative shoulder and abdominal pain in the early postoperative period is still quite significant. This postoperative pain is a major concern not only for the patients, but also healthcare workers; and it often contributes to overnight hospital stay after this minimally invasive surgical procedure. Intraperitoneal instillation of local anesthetics at the time of surgery to control pain after laparoscopic cholecystectomy has been extensively studied in numerous randomized trials and found to be extremely useful. Lignocaine and Bupivacaine are two commonly used local anesthetic agents. In view of contradictory results from previous studies, it is not yet clear which of these two agents is superior to the other for pain control in this setting. To answer this question, we have designed a prospective randomized controlled trial and the specific aim of the study is to compare the analgesic efficacy of intraperitoneal lignocaine with intraperitoneal Bupivacaine in the postoperative setting after laparoscopic cholecystectomy.
If we can improve pain control after this minimally invasive procedure, it might result in decreased postoperative requirement of narcotic analgesia and its associated side-effects. It may also result in early recovery and the same day discharge of the patients with significant cost-containment for the patient and healthcare systems in future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intraperitoneal lignocaine | Active comparator | Drug: lignocaine, Drug: bupevacaineIntraperitoneal lignocaine will be compared with intraperitoneal bupevacaine for pain control after laparoscopic cholecystectomy |
| intraperitoneal bupevacaine | Active comparator | Drug: lignocaine, Drug: bupevacaineintraperitoneal lignocaine will be compared with intraperitoneal bupevacaine after laparoscopic cholecystectomy |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of symptomatic gallstones requiring laparoscopic cholecystectomy
- Elective surgical procedure
- American Society of Anesthesiologists class I and II
Key exclusion criteria (8 listed)
- Patients refusing randomization
- Patients already on analgesics
- Patients with acute cholecystitis
- Patients requiring preoperative cholangiogram or common bile duct exploration
- Patients having bile or stone spillage during procedure
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 |
|---|---|---|
| lignocaine200 mg of intraperitoneal lignocaine will be given once during surgery | Drug | intraperitoneal bupevacaine, intraperitoneal lignocaine |
| bupevacaine100 mg of bupevacaine will be given once during laparoscopic cholecystectomy | Drug | intraperitoneal bupevacaine, intraperitoneal lignocaine |
Primary outcome
Pain Control after Laparoscopic Cholecystectomy
Time frame: 24 hours after surgery
1 secondary outcome
Requirement of Analgesia after laparoscopic cholecystectomy
Time frame: 24 hours after surgery
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 25 Jan 2011.
Related trials for Laparoscopic Cholecystectomy
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Comparison of Intertransverse Process and Erector Spinae Plane Blocks in Acute Postoperative Analgesia Management for Laparoscopic Cholecystectomy Patients
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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.
Muhammad R Khan, FRCS principal investigator
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lignocaine and bupevacaine in people with Laparoscopic Cholecystectomy, run by Aga Khan University at 1 site in Pakistan.
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 8 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 25 Jan 2011. 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 Pakistan. 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?
Pain Control after Laparoscopic Cholecystectomy (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 25 Jan 2011.