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Randomised single blinded trial of surgically placed pre-peritoneal vs ultrasound placed rectus sheath catheters post laparotomy.

Randomised single blinded trial of surgically placed pre-peritoneal vs ultrasound placed rectus sheath catheters post laparotomy.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001448336
Enrollment
72
Registered
2017-10-12
Start date
2017-11-06
Completion date
2018-12-28
Last updated
2017-10-16

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

Conditions

None listed

Brief summary

This study aims to compare post-operative pain outcomes following the placement of rectus sheath catheters by surgeons and anaesthetist. A total of 72 patients will be included in this study, with 36 in each arm. One arm will receive rectus sheath catheters placed into the pre-peritoneal space intraoperatively by the operating surgeon, while the other arm will receive rectus sheath catheters placed under ultrasound guidance by an anaesthetist into the intrafasicular space. Both arms will then receive 20mL 0.2% Ropivacaine infusion through these catheters every 4 hrs for 3 days. The post-operative pain experience will be assessed by narcotic requirements which will be documented as IV morphine equivalents.

Interventions

1. All patients recruited (undergoing a laparotomy) will be randomised into two groups either receiving a rectus sheath catheter inserted by a General Surgeon intra-operatively into the pre-peritoneal space under direct visualisation or by an Anaesthetist into the intra-fascicular space via ultrasound guidance post-operatively. 2. Rectus sheath catheters placed by General Surgery will be on completion of the operation, prior to closure of the laparotomy wound. Anaesthetic placement of rectus

1. All patients recruited (undergoing a laparotomy) will be randomised into two groups either receiving a rectus sheath catheter inserted by a General Surgeon intra-operatively into the pre-peritoneal space under direct visualisation or by an Anaesthetist into the intra-fascicular space via ultrasound guidance post-operatively. 2. Rectus sheath catheters placed by General Surgery will be on completion of the operation, prior to closure of the laparotomy wound. Anaesthetic placement of rectus sheath catheters will be at the end of the entire operation, prior to waking the patient up from general anaesthetic. Devices by both arms are standardised to 16G 110mm Touhy Needle, 16G Epidural catheter (multiperforated with 3 lateral eyes), 16/17G LOCKIT PLUS regional anaesthesia catheter securement device, ALARIS PRODUCTS 0.2microm Line Filters, 20ml Luer-lock syringe, Opsite Flexigrid (10X12cm). In regards to adherence and standardisation of procedure, prior to commencement of this study, consultant general surgeons and anaesthetists performing rectus sheath catheter insertions will be given a information session on placement of these catheters, equipments to be used and dosage of local anaesthetic to be infused (0.2% : 10-20mg/hr for up to 72hrs). These educational sessions will be led by the director of surgery and anaesthetics.

Sponsors

Mackay Base Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

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

Inclusion criteria

All adult general surgical patients undergoing a midline laparotomy at Mackay base hospital

Exclusion criteria

- Local Anaesthetic allergy - Catheter plastic allergy - Multiple operations as defined as alteration of anatomy of the abdominal wall, preventing placement of catheters. - Chronic abdominal pain as defined as abdominal pain with opiate use for > 12 weeks - Abdomen left open - Patient under 18 years of age - Pregnant - Inability of surgical/anaesthetic staff to perform procedure - Patients with altered cognition (dementia or delirium) and therefore unable to respond to VAS. - Patients intubated & therefore unable to communicate

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026