RopivacainePhase 4NCT03265223
Ropivacaine Use Intraincisionally Versus Intraperitoneally for Post-Laparoscopic Cholecystectomy Pain
A Phase 4 study testing 0.2% ropivacaine in people with Ropivacaine and Laparoscopic Cholecystectomy, run by Jawaharlal Nehru Medical College.
Trial summary
Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic cholecystectomy. Almost all earlier studies done to compare the efficacy of local anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of drugs at the two locations, usually 10-20 ml. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Ropivacaine, Laparoscopic Cholecystectomy, Pain
- What is being tested?
- 0.2% ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 353 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2014to 15 Aug 2017
- 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 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients in the age group of 15-80 years
- Patients conferring to Grade I or II of American Society of Anesthesiologists (ASA) physical status classification system only
- Patients undergoing elective Laparoscopic Cholecystectomy
- Patients having symptomatic cholelithiasis only
- Patients operated by a single surgeon were included.
Who cannot join
- Patients with known allergic reactions to local anesthetics
- Cases that were converted to open cholecystectomy
- Patients with major intra-operative complications
- Patients suffering from acute cholecystitis, empyema or malignancy of gall bladder, having history of chronic pain or those taking frequent analgesics or opioids pre-operatively
- Patients with peptic ulceration, bleeding disorders, impaired renal and/or hepatic function, and sensitivity to NSAIDs or opioids.
- Patients in whom gall bladder (GB) stones are found incidentally on ultrasonography (USG) (asymptomatic cholelithiasis)
- Patients suffering from severe chronic medical diseases and morbid obesity
- Patients unable to comprehend instructions or having communication problems were excluded from the study.
About this study
Official title: Randomized Controlled Study of Intraincisional Infiltration Versus Intraperitoneal Instillation of Standardized Dose of Ropivacaine 0.2% in Post-laparoscopic Cholecystectomy Pain
Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic cholecystectomy. Almost all earlier studies done to compare the efficacy of local anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small space of intraincisional location as compared to similar amount of drug in large intraperitoneal space created an inadvertent bias in favor of patients receiving the drug intraincisionally so such patients naturally experienced less pain. The investigators decided to standardize the drug used at these two locations as 1ml/cm and conduct a new study comparing the effects of drugs in relieving pain when used at these two locations.
Read the detailed description
Aims \& Objectives: To conduct a randomized, triple-blind, placebo-controlled study by standardizing dose of local anesthetic, to compare the effectiveness of intraperitoneal against intraincisional use of ropivacaine 0.2% for post-laparoscopic cholecystectomy pain relief.
Materials \& Methods: American Society of Anesthesiologists (ASA) physical status I or II patients underwent elective 4 port laparoscopic cholecystectomy by a single surgeon. Anesthetic and surgical techniques were standardized. Patients were randomized using envelope method into 3 groups according to location of drug use. Triple blinding was ensured and envelopes were opened only at the completion of study. All patients received ~23 ml of solution, of which 20 ml was given intraperitoneally [1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and ~3 ml intraincisionally (1 ml/cm of length of incision). Controls (n=86) received ~23 ml normal saline (20 ml intraperitoneally and 1 ml/cm intraincisionally) while the intraperitoneal group (n=100) received 20 ml of intraperitoneal instillation of injection ropivacaine 0.2% and 1 ml/cm of normal saline intraincisionally at the end of procedure. Intraincisional group (n=108) received 20 ml normal saline intraperitoneally and 1 ml/cm of injection ropivacaine 0.2% infiltration at incisional site at the end of procedure. All patients received injection diclofenac sodium 75mg/1ml (aqueous) intravenously 12 hourly postoperatively. 5 different pain scales were used for assessment of overall pain. Pain scores were assessed at 5 points of time, that is, at 0.5, 4, 8, 12 and 24 hours postoperatively. Shoulder pain and extra dose of analgesic required (rescue analgesia) were also recorded.
- Conditions
- Ropivacaine, Laparoscopic Cholecystectomy, Pain
- Being tested
- 0.2% ropivacaine
- Keywords
- Ropivacaine, local anesthesia, intraincisional infiltration, intraperitoneal instillation, post-laparoscopic cholecystectomy pain, shoulder pain, rescue analgesia, triple blinding
- Medical subject headings
- Pain, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.2% ropivacaineDrug
Also called Ropin, Naropin
Intraperitoneal instillation versus intraincisional infiltration
| Study group | Role | What they receive |
|---|---|---|
| Controls | No intervention | Received 1 ml/cm normal saline (23 ml) both at intraperitoneal (=20 ml) as well as intraincisional (=3 ml) location. |
| Intraperitoneal group | Active comparator | Received 20 ml of 0.2% ropivacaine intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml normal saline (1ml/cm of port site incision length) Receives: Drug: 0.2% ropivacaine |
| Intraincisional group | Active comparator | Received 20 ml of normal saline intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml 0.2% ropivacaine (1ml/cm of port site incision length) Receives: Drug: 0.2% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain
To study and assess the effect and impact of using the local anesthetic ropivacaine 0.2%, over controls, on the intensity of postoperative pain in patients undergoing laparoscopic cholecystectomy; and to compare and assess the optimal site i.e. intraincisional versus intraperitoneal of using local anesthetic (ropivacaine) for better post-laparoscopic cholecystectomy pain relief.
Measured: 36 months
Secondary outcomes (3)
Identify the component of pain which is dominant after undergoing laparoscopic cholecystectomy
To identify the component of pain (visceral versus incisional component) that is dominant after laparoscopic cholecystectomy; and after how much interval of time it assumes importance?
Measured: 36 months
Laparoscopic cholecystectomy as day-case using ropivacaine only
To strive for making laparoscopic cholecystectomy a truly day case procedure in the public setup of developing countries like India by using this cheap local anaesthetic alone
Measured: 36 months
Changing trends in epidemiology of cholelithiasis
To check for any changing trends in epidemiology of cholelithiasis in North India
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Apr 2014
- Primary completion31 Mar 2017
- Study completion15 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RopivacaineStudies 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
- Model description
- Three study groups: Controls received no drug, intraperitoneal group received drug along right hemidiaphragm and in gallbladder fossa while intraincisional group received drug by infiltration at trocar site
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jawaharlal Nehru Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kaushal Deep Singh, Jawaharlal Nehru Medical College
- Investigators
- Kaushal D Singh, MS Surgery, Principal investigator, Jawaharlal Nehru Medical College, Aligarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265223
- Sponsor's protocol ID
- JawaharlalNMC
- Status last verified
- Aug 2017
- First submitted
- 22 Aug 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data of those patients will be shared patients who will give consent for the same.
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Intraincisional Infiltration Versus Intraperitoneal Instillation of Standardized Dose of Ropivacaine 0.2% in Post-laparoscopic Cholecystectomy Pain
- ClinicalTrials.gov ID
- NCT03265223
- Acronym / sponsor ID
- JawaharlalNMC
- Conditions
- Ropivacaine, Laparoscopic Cholecystectomy, Pain
- Keywords
- Ropivacaine, local anesthesia, intraincisional infiltration, intraperitoneal instillation, post-laparoscopic cholecystectomy pain, shoulder pain, rescue analgesia, triple blinding
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Jawaharlal Nehru Medical CollegeUniversity, hospital or other
- Study start
- 1 Apr 2014 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 15 Aug 2017 (actual)
- First posted
- 29 Aug 2017 (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.
Pain still remains a limiting factor in early discharge of patients undergoing laparoscopic cholecystectomy. Almost all earlier studies done to compare the efficacy of local anaesthetics used intraperitoneally as compared to intraincisionally used equal amounts of drugs at the two locations, usually 10-20 ml. Using this large amount of drug in the small space of intraincisional location as compared to similar amount of drug in large intraperitoneal space created an inadvertent bias in favor of patients receiving the drug intraincisionally so such patients naturally experienced less pain. The investigators decided to standardize the drug used at these two locations as 1ml/cm and conduct a new study comparing the effects of drugs in relieving pain when used at these two locations.
Detailed description
Aims \& Objectives: To conduct a randomized, triple-blind, placebo-controlled study by standardizing dose of local anesthetic, to compare the effectiveness of intraperitoneal against intraincisional use of ropivacaine 0.2% for post-laparoscopic cholecystectomy pain relief.
Materials \& Methods: American Society of Anesthesiologists (ASA) physical status I or II patients underwent elective 4 port laparoscopic cholecystectomy by a single surgeon. Anesthetic and surgical techniques were standardized. Patients were randomized using envelope method into 3 groups according to location of drug use. Triple blinding was ensured and envelopes were opened only at the completion of study. All patients received ~23 ml of solution, of which 20 ml was given intraperitoneally [1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and ~3 ml intraincisionally (1 ml/cm of length of incision). Controls (n=86) received ~23 ml normal saline (20 ml intraperitoneally and 1 ml/cm intraincisionally) while the intraperitoneal group (n=100) received 20 ml of intraperitoneal instillation of injection ropivacaine 0.2% and 1 ml/cm of normal saline intraincisionally at the end of procedure. Intraincisional group (n=108) received 20 ml normal saline intraperitoneally and 1 ml/cm of injection ropivacaine 0.2% infiltration at incisional site at the end of procedure. All patients received injection diclofenac sodium 75mg/1ml (aqueous) intravenously 12 hourly postoperatively. 5 different pain scales were used for assessment of overall pain. Pain scores were assessed at 5 points of time, that is, at 0.5, 4, 8, 12 and 24 hours postoperatively. Shoulder pain and extra dose of analgesic required (rescue analgesia) were also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Three study groups: Controls received no drug, intraperitoneal group received drug along right hemidiaphragm and in gallbladder fossa while intraincisional group received drug by infiltration at trocar site
| Arm | Type | Receives |
|---|---|---|
| Controls | No intervention | –Received 1 ml/cm normal saline (23 ml) both at intraperitoneal (=20 ml) as well as intraincisional (=3 ml) location. |
| Intraperitoneal group | Active comparator | Drug: 0.2% ropivacaineReceived 20 ml of 0.2% ropivacaine intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml normal saline (1ml/cm of port site incision length) |
| Intraincisional group | Active comparator | Drug: 0.2% ropivacaineReceived 20 ml of normal saline intraperitoneally (1 ml/cm; 16 ml along right hemi-dome, approximately equal to length of right hemi-dome of diaphragm in an average adult and 4 ml in gall bladder fossa) and 3 ml 0.2% ropivacaine (1ml/cm of port site incision length) |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- All patients in the age group of 15-80 years
- Patients conferring to Grade I or II of American Society of Anesthesiologists (ASA) physical status classification system only
- Patients undergoing elective Laparoscopic Cholecystectomy
- Patients having symptomatic cholelithiasis only
- Patients operated by a single surgeon were included.
Key exclusion criteria (8 listed)
- Patients with known allergic reactions to local anesthetics
- Cases that were converted to open cholecystectomy
- Patients with major intra-operative complications
- Patients suffering from acute cholecystitis, empyema or malignancy of gall bladder, having history of chronic pain or those taking frequent analgesics or opioids pre-operatively
- Patients with peptic ulceration, bleeding disorders, impaired renal and/or hepatic function, and sensitivity to NSAIDs or opioids.
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 |
|---|---|---|
| 0.2% ropivacaineAlso: Ropin, NaropinIntraperitoneal instillation versus intraincisional infiltration | Drug | Intraincisional group, Intraperitoneal group |
Primary outcome
Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain
Time frame: 36 months
To study and assess the effect and impact of using the local anesthetic ropivacaine 0.2%, over controls, on the intensity of postoperative pain in patients undergoing laparoscopic cholecystectomy; and to compare and assess the optimal site i.e. intraincisional versus intraperitoneal of using local anesthetic (ropivacaine) for better post-laparoscopic cholecystectomy pain relief.
3 secondary outcomes
Identify the component of pain which is dominant after undergoing laparoscopic cholecystectomy
Time frame: 36 months
Laparoscopic cholecystectomy as day-case using ropivacaine only
Time frame: 36 months
Changing trends in epidemiology of cholelithiasis
Time frame: 36 months
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 30 Aug 2017.
- Individual participant dataSharing planned: Undecided. Data of those patients will be shared patients who will give consent for the same.
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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.
Kaushal D Singh, MS Surgery principal investigator
Jawaharlal Nehru Medical College, Aligarh
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.2% ropivacaine in people with Ropivacaine and Laparoscopic Cholecystectomy, run by Jawaharlal Nehru Medical College.
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 5 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 30 Aug 2017. 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. 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?
Effect of ropivacaine use intraincisionally versus intraperitoneally as compared to controls on post-laparoscopic cholecystectomy pain (time frame: 36 months). 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 30 Aug 2017.