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Intravenous lidocaine in the prevention of postoperative ileus

A randomised double blind placebo controlled trial of intravenous lidocaine to reduce the duration of postoperative ileus in patients undergoing elective colorectal surgery

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000123246
Enrollment
140
Registered
2018-01-29
Start date
2018-02-01
Completion date
2018-09-28
Last updated
2018-02-05

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

Conditions

None listed

Brief summary

Postoperative ileus (POI) is a common sequelae of abdominal surgery and is characterised by a period of gastrointestinal dysmotility. Common symptoms include nausea, vomiting, inability to tolerate oral diet and inability to pass flatus or stool. Patients with POI commonly have abdominal distension, they may require nasogastric tube (NGT) insertion to relieve gastric distension. POI interferes with patient mobility post operatively and evidence suggests that more than 50% of patients who develop POI will also develop further complications, significantly increasing their postoperative length of stay and mortality. POI is a common condition, a recent series at Auckland City Hospital identified 26.9% of patients as having prolonged postoperative ileus. This is an issue which places a significant burden on healthcare resources and spending; a recent study estimates an annual economic burden of over $1.4 billion in the United States alone. The exact mechanism of POI is unclear, however important factors in its development include use of pharmacological agents (particularly opiates), neural mechanisms, and intestinal inflammation. Anti-inflammatory drugs such as COX-2 inhibitors have shown some effect in animal and human models in preventing and reducing the duration of POI. Lidocaine is a local anaesthetic medication. Similar local anaesthetic medications are routinely used in elective surgery for analgesia via epidural or local infiltration. There is evidence that epidural local anaesthetic is effective in the prevention of POI. It has recently been suggested that the clinical effect is due to systemic absorption of the local anaesthetic, studies have shown that intravenously administered local anaesthetic is effective at reducing rates of POI. The mechanism of action may be due to reduced opiate consumption post operatively due to the analgesic effect of lidocaine, however studies have shown a significant attenuation of the post-surgical inflammatory response following administration of parenteral lidocaine, and this may also contribute to its’ effect. This study aims to assess the duration of POI following the administration of parenteral lidocaine intraoperatively and up to 2 hours post operatively, compared to placebo. Primary end points will include, time to resolution of POI as defined by established criteria. Secondary end points will include pain scores, markers of systemic inflammation, complication rates and length of hospital stay.

Interventions

Patients in the intervention group undergoing colorectal surgery will be administered intravenous lidocaine. The dose of lidocaine will be 2mg/kg bolus at induction of anaesthesia with a 2mg/kg/hr infusion to a maximum of 150mg/hr, the infusion will continue until 2 hours post op

Sponsors

University of Otago, Christchurch
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

All patients undergoing elective colorectal surgery Able to give informed consent

Exclusion criteria

• Allergy to lidocaine • ASA 4 or greater • Active inflammatory bowel disease • Moderate to severe renal impairment (Creatinine clearance <50ml/min/1.73m2) • Severe hepatic impairment (Child-Pugh C) • Moderate to severe congestive cardiac failure (NHYA 3 or 4) • Pregnancy • Pre-existing gut dysmotility disorder including endocrine, metabolic or neurological cause • Pre-operative malnutrition requiring parenteral nutrition • Inability to give consent or participate in post-operative assessments • Primary, secondary or tertiary heart block • Shock • Drugs known to reduce lidocaine metabolism e.g. cimetidine

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026