Laparoscopic Colon ResectionPhase 4NCT03105193
Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections
A Phase 4 study testing IV Saline bolus and infusion, IP Saline bolus and infusion and IV lignocaine bolus and infusion in people with Laparoscopic Colon Resection and Perioperative Analgesia, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial summary
The aim of this study is to investigate the analgesic effects of intraperitoneal lignocaine (IPL) compared with intravenous lignocaine (IVL) after laparoscopic colon resections. We plan to run a 2 group randomized, double blind, clinical trial which will look into morphine consumption as the primary outcome. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Colon Resection, Perioperative Analgesia
- What is being tested?
- IV Saline bolus and infusion, IP Saline bolus and infusion and IV lignocaine bolus and infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNew Zealand
- Study dates
- 17 Aug 2018to 30 Dec 2019
- 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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- consecutive consenting patients undergoing elective laparoscopic colonic resections will be recruited from surgical outpatient clinics at Manukau Super Clinic.
Who cannot join
- under 16 years of age
- acute colonic resection
- those with ASA >= 4
- previous adverse reaction/allergy to local anaesthetic,
- surgery for rectal lesions which was defined as lesion within 15 cm of the anal verge
- preoperative systemic steroid dependence
Show all 9Show fewer
- hepatic dysfunction, opioid use greater than 6 months
- a diagnosis of Chronic Pain Syndrome
- inability to consent or complete data scores in the study questionnaires due to cognitive impairment and/or language barrier.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to investigate the analgesic effects of intraperitoneal lignocaine (IPL) compared with intravenous lignocaine (IVL) after laparoscopic colon resections. We plan to run a 2 group randomized, double blind, clinical trial which will look into morphine consumption as the primary outcome.
Group 1 (IV lignocaine)- IV bolus of lignocaine and a 3 day post operative IV lignocaine infusion. Intra peritoneal (IP) bolus of normal saline + 3 day post operative IP normal saline infusion
Group 2 (IP lignocaine)- IV bolus of normal saline and a 3 day post operative IV normal saline infusion. IP bolus of lignocaine + 3 day post operative IP lignocaine infusion
Read the detailed description
Over the last 20 years, laparoscopic colonic surgery has become an accepted first-line treatment for colon cancer. A population-based study showed that laparoscopic colonic resections can be performed with lower hospital costs up to 90 days after discharge when compared to open surgery. Laparoscopic colonic resections have also been associated with fewer postoperative complications and lower mortality.
New Zealand has one of the highest rates of bowel cancer in the world, and it is the second highest cause of cancer deaths in New Zealand. With the implementation of a bowel screening programme in New Zealand, the projected numbers of stage 1 bowel cancers are expected to increase. More avenues to improve perioperative care need to be explored to improve patient outcomes.
Controlling postoperative pain effectively has been shown to reduce the length of hospital stay and improve patient/clinical outcomes. Opioids work as μ-receptor agonists in the spinal cord and brain, and although opioids are excellent at reducing pain, they are associated with nausea, vomiting, dizziness, decreased blood pressure, and urinary retention. Epidurals have been incorporated into Enhanced Recovery After Surgery protocols for controlling post-operative pain. However, epidurals are an invasive procedure with significant side effects such as hypotension, urinary retention, respiratory depression, motor blockade and rarely epidural abscess and meningitis. It has also been shown that up to 30 percent of epidural catheters dislodge, block or leak. These complications have led to a movement towards other regional analgesia techniques which allow local anaesthetic (LA) to target the abdominal wound specifically.
Intraperitoneal local anaesthetic (IPLA) has shown promise in reducing pain after colonic surgery with a meta-analysis9, and a recent IPLA colorectal study conducted at Counties Manukau health showing that it reduces pain and opioid use over and above the effect of an epidural10, which is primarily aimed at the abdominal wound. After an IPLA bolus serum local anaesthetic levels are detectable within 2 minutes. Some studies show reduced early postoperative pain and opioid consumption with intravenous lignocaine infusion alone. The question remains however if there is a benefit from using intraperitoneal local anaesthetic compared to administering it intravenously as the IPLA should block both the intraabdominal wound, via a local action, and the skin wound via a systemic action.. This has been investigated in four studies, however none of these studies compared intravenous local anaesthetic (IVLA) and IPLA for colon resection.
The aim is that, by optimising analgesia regimes using local anaesthetic, we can improve patient experience of pain and recovery thereby achieving an earlier discharge and early recovery from surgery. This has significant economic benefits for all involved.
- Being tested
- IV Saline bolus and infusion, IP Saline bolus and infusion, IV lignocaine bolus and infusion, IP Lignocaine bolus and infusion
- Keywords
- Colon surgery, Lignocaine, Lidocaine, Analgesia, Local anaesthetic
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Saline bolus and infusionDrug
Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump
IP Saline bolus and infusionDrug
Also called Lidocaine
Intraperitoneal bolus of normal saline down first port site. 3 day post operative intraperitoneal infusion of normal saline via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump.
IV lignocaine bolus and infusionDrug
Also called Lidocaine
Intravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump
IP Lignocaine bolus and infusionDrug
Intraperitoneal bolus of lignocaine down first port site. 3 day post operative intraperitoneal infusion of lignocaine via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal Lignocaine | Experimental | IP Lignocaine Receives: Drug: IV Saline bolus and infusion; Drug: IP Lignocaine bolus and infusion |
| Intravenous lignocaine | Experimental | IV lignocaine Receives: Drug: IP Saline bolus and infusion; Drug: IV lignocaine bolus and infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
Total morphine consumption at day 3
Measured: 3 days
Secondary outcomes (7)
Pain scores
Pain scores using the visual analogue score (VAS)
Measured: 0, 6, 12 hours and Postoperative day (POD) 1, 2, 3, 4 and 7
Systemic Inflammatory Response (CRP and WBC)
Blood test
Measured: very morning post op starting day 1 until day 4 post op
Systemic Local Anesthetic Level
Blood test
Measured: every morning post op starting day 1 until day 4 post op
Length of stay
The day that the patient is discharged will be recorded
Measured: Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Return of bowel function
Time to flatus, first bowel motion
Measured: Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Readmissions complications
Readmissions complications will be recorded up to day 30 post op using the Clavien-Dindo Classification
Measured: 30 days post op
Surgical recovery scores (SRS)
SRS questionnaires will be administered at day 1 till discharge then POD 14, 30 and 60
Measured: Up to 60 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start17 Aug 2018
- Primary completion1 Dec 2019
- Study completion30 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Colon ResectionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew G Hill, MBChB, MD (Thesis), EdD, FACS, FRACS, University of Auckland, New Zealand
- Investigators
- Andrew G Hill, Principal investigator, The University of Auckland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105193
- Sponsor's protocol ID
- IPL/IVL
- Status last verified
- Nov 2020
- First submitted
- 23 Mar 2017
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous and Intraperitoneal Lignocaine for Perioperative Analgesia in Laparoscopic Colon Resections
- ClinicalTrials.gov ID
- NCT03105193
- Acronym / sponsor ID
- IPL/IVL
- Keywords
- Colon surgery, Lignocaine, Lidocaine, Analgesia, Local anaesthetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- 17 Aug 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 30 Dec 2019 (actual)
- First posted
- 7 Apr 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.
The aim of this study is to investigate the analgesic effects of intraperitoneal lignocaine (IPL) compared with intravenous lignocaine (IVL) after laparoscopic colon resections. We plan to run a 2 group randomized, double blind, clinical trial which will look into morphine consumption as the primary outcome.
Group 1 (IV lignocaine)- IV bolus of lignocaine and a 3 day post operative IV lignocaine infusion. Intra peritoneal (IP) bolus of normal saline + 3 day post operative IP normal saline infusion
Group 2 (IP lignocaine)- IV bolus of normal saline and a 3 day post operative IV normal saline infusion. IP bolus of lignocaine + 3 day post operative IP lignocaine infusion
Detailed description
Over the last 20 years, laparoscopic colonic surgery has become an accepted first-line treatment for colon cancer. A population-based study showed that laparoscopic colonic resections can be performed with lower hospital costs up to 90 days after discharge when compared to open surgery. Laparoscopic colonic resections have also been associated with fewer postoperative complications and lower mortality.
New Zealand has one of the highest rates of bowel cancer in the world, and it is the second highest cause of cancer deaths in New Zealand. With the implementation of a bowel screening programme in New Zealand, the projected numbers of stage 1 bowel cancers are expected to increase. More avenues to improve perioperative care need to be explored to improve patient outcomes.
Controlling postoperative pain effectively has been shown to reduce the length of hospital stay and improve patient/clinical outcomes. Opioids work as μ-receptor agonists in the spinal cord and brain, and although opioids are excellent at reducing pain, they are associated with nausea, vomiting, dizziness, decreased blood pressure, and urinary retention. Epidurals have been incorporated into Enhanced Recovery After Surgery protocols for controlling post-operative pain. However, epidurals are an invasive procedure with significant side effects such as hypotension, urinary retention, respiratory depression, motor blockade and rarely epidural abscess and meningitis. It has also been shown that up to 30 percent of epidural catheters dislodge, block or leak. These complications have led to a movement towards other regional analgesia techniques which allow local anaesthetic (LA) to target the abdominal wound specifically.
Intraperitoneal local anaesthetic (IPLA) has shown promise in reducing pain after colonic surgery with a meta-analysis9, and a recent IPLA colorectal study conducted at Counties Manukau health showing that it reduces pain and opioid use over and above the effect of an epidural10, which is primarily aimed at the abdominal wound. After an IPLA bolus serum local anaesthetic levels are detectable within 2 minutes. Some studies show reduced early postoperative pain and opioid consumption with intravenous lignocaine infusion alone. The question remains however if there is a benefit from using intraperitoneal local anaesthetic compared to administering it intravenously as the IPLA should block both the intraabdominal wound, via a local action, and the skin wound via a systemic action.. This has been investigated in four studies, however none of these studies compared intravenous local anaesthetic (IVLA) and IPLA for colon resection.
The aim is that, by optimising analgesia regimes using local anaesthetic, we can improve patient experience of pain and recovery thereby achieving an earlier discharge and early recovery from surgery. This has significant economic benefits for all involved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal Lignocaine | Experimental | Drug: IV Saline bolus and infusion, Drug: IP Lignocaine bolus and infusionIP Lignocaine |
| Intravenous lignocaine | Experimental | Drug: IP Saline bolus and infusion, Drug: IV lignocaine bolus and infusionIV lignocaine |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- consecutive consenting patients undergoing elective laparoscopic colonic resections will be recruited from surgical outpatient clinics at Manukau Super Clinic.
Key exclusion criteria (9 listed)
- under 16 years of age
- acute colonic resection
- those with ASA >= 4
- previous adverse reaction/allergy to local anaesthetic,
- surgery for rectal lesions which was defined as lesion within 15 cm of the anal verge
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 |
|---|---|---|
| IV Saline bolus and infusionIntravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump | Drug | Intraperitoneal Lignocaine |
| IP Saline bolus and infusionAlso: LidocaineIntraperitoneal bolus of normal saline down first port site. 3 day post operative intraperitoneal infusion of normal saline via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump. | Drug | Intravenous lignocaine |
| IV lignocaine bolus and infusionAlso: LidocaineIntravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump | Drug | Intravenous lignocaine |
| IP Lignocaine bolus and infusionIntraperitoneal bolus of lignocaine down first port site. 3 day post operative intraperitoneal infusion of lignocaine via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump. | Drug | Intraperitoneal Lignocaine |
Primary outcome
Morphine consumption
Time frame: 3 days
Total morphine consumption at day 3
7 secondary outcomes
Pain scores
Time frame: 0, 6, 12 hours and Postoperative day (POD) 1, 2, 3, 4 and 7
Systemic Inflammatory Response (CRP and WBC)
Time frame: very morning post op starting day 1 until day 4 post op
Systemic Local Anesthetic Level
Time frame: every morning post op starting day 1 until day 4 post op
Length of stay
Time frame: Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Return of bowel function
Time frame: Variable measure as it is dependent on the patients recovery after surgery. Cut off 3 weeks
Readmissions complications
Time frame: 30 days post op
Surgical recovery scores (SRS)
Time frame: Up to 60 days post op
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 3 Nov 2020.
- 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.
Andrew G Hill principal investigator
The University of Auckland
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 IV Saline bolus and infusion, IP Saline bolus and infusion and IV lignocaine bolus and infusion in people with Laparoscopic Colon Resection and Perioperative Analgesia, run by University of Auckland, New Zealand at 1 site in New Zealand.
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 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 3 Nov 2020. 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 New Zealand. 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.
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?
Morphine consumption (time frame: 3 days). 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 3 Nov 2020.