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Comparison of post-operative mobility recovery in participants undergoing keyhole colorectal surgery treated with intraperitoneal ropivacaine/placebo for post-op pain management.

A double-blinded randomised placebo-controlled clinical trial assessing postoperative recovery using intraperitoneal local anaesthetic in laparoscopic colorectal surgery.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000359437
Acronym
LAPLAP study
Enrollment
96
Registered
2016-03-21
Start date
2016-07-08
Completion date
2017-12-05
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Most colorectal surgery is now performed laparoscopically. Therefore most pain is deep inside the abdomen rather than the small incisions on the abdominal wall. This study would like to use a pain management technique that uses local anaesthetic infused via plastic catheters into the intraperitoneal space in the abdomen, close to the internal incisions. It is hoped that by doing this patients will need to use less opioid drugs and thereby avoid the side effects of these drugs and possibly recover more quickly from the surgical procedure with less pain. Currently there are many different pain management techniques used after surgery and include: -Intravenous pain medication with opioid drugs such as Morphine or Fentanyl. -Epidural (small plastic tube inserted near spinal cord where medication can be given) with a combination of local anaesthetic drugs +/- morphine-like drugs. -Local anaesthetic blocks via small plastic tubes placed between the abdominal muscles at the time of operation and allow for local anaesthetic to be given between these muscles. -Oral pain medication such as paracetamol and oxycodone. -A combination of any of the above techniques. These techniques can have side effects especially with the Morphine-like drugs that can be a problem in patients having surgery on the bowel and include: -Nausea and vomiting -Reduced bowel function (constipation or bowel temporarily stops working - ileus) -Drowsiness or sleepiness -Slowed respiratory rate and reduced cough -Reduced mobility leading to prolonged bedrest -Increased risk of blood clots due to immobility Because of these side effects the study is designed to see if the local anaesthetic infused intraperitoneally will result in improved pain relief, mobility, earlier return of gut function and less complications,

Interventions

Ropivacaine hydrochloride 0.2% continuous infusion of up to 4mls per hour (depending on patient weight, as prescribed by the treating Anaesthetist) via intraperitoneal catheter administered post-operatively up to 5 days as determined by the treating surgical team or pain team. Other anaesthetic agents for the operative procedure will be at the discretion of the treating Anaesthetist.

Sponsors

Hunter New England Local Health District
Lead SponsorGovernment body

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

All patients undergoing elective or semi-urgent booked laparoscopic colorectal resection

Exclusion criteria

Patients from the above group will be excluded if they: -are under 18 years of age, or -Refuse or are unable to give written informed consent to participate in the study, or -have severe renal impairment or -receive an epidural, spinal or other neuroaxial anaesthetic, or -receive an operation that involved extra incisions outside the abdominal wall (such as abdomino-perineal resections) or -have a known allergy or adverse drug reaction to local anaesthetic agents or morphine or fentanyl, or -have a history of arrhythmia or long QT syndrome associated with the drugs used in this trial, or -remain intubated post procedure -Pregnant or lactating females -Are taking regular opiate narcotics pre-operatively

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026