Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone. (PROSP)

York Teaching Hospitals NHS Foundation Trust

Status: Completed

Conditions: Colorectal Cancer

Treatments: Drug: Diamorphine; Procedure: Continuous infusion of local anaesthetic; Device: 25G Whitacre needle; Procedure: Spinal and infusion of local anaesthetic; Drug: Bupivacaine; Device: A Painbuster® catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02210260

SNE 2190

Details and patient eligibility

About

Limiting surgical stress and managing postoperative pain are well understood to influence recovery and outcome from major surgery for colorectal cancer and both are fundamental aspects of enhanced recovery protocols.

Traditional approaches for dealing with these problems such as epidural or patient controlled intravenous opioid analgesia are associated with problems that may be detrimental to postoperative recovery and surgical outcome. As a result there is evidence in the literature of increasing interest in alternative techniques such as intrathecal anaesthesia or continuous wound infusion of local anaesthetic, however nobody has examined the effect of combining the techniques or their impact on the surgical stress response.

We intend to compare patients undergoing major resections for colorectal cancer receiving intrathecal anaesthesia in combination with a wound infusion of local anaesthetic with those receiving a continuous wound infusion alone. We will examine the surgical stress response and postoperative pain control in addition to objective measures of postoperative recovery.

We suggest that our approach will attenuate the surgical stress response and provide optimal pain control that will ultimately translate in improved recovery and outcome following surgery for colorectal cancer.

Full description

This is a pilot randomised controlled trial

Hypotheses -

Following colorectal surgery, spinal anaesthesia combined with a continuous infusion of local anaesthetic into the surgical wound provides

1. better pain relief
2. a reduced stress response

when compared to the use of continuous infusion of local anaesthetic into the surgical wound alone.

Patients undergoing surgical resection for colorectal cancer will be randomised to receive either

1. A single shot of spinal anaesthesia plus a continuous infusion of local anaesthetic into the surgical wound or
2. Continuous infusion of local anaesthetic into the surgical wound

Spinal Anaesthesia

The spinal anaesthetic (SA) with be placed after commencement of general anaesthesia this will ensure the patients remain blinded to the intervention. SA will be performed in the lateral position using a midline approach. L3/4 interspace will be identified using Tuffier's as the anatomical landmark. After confirmation of correct placement using a 25G Whitacre needle, 12.5 mg of hyperbaric Bupivacaine in a mixture with 500mcg Diamorphine will be injected intrathecally.

Infusion of local anaesthetic

The catheter through which the infusion of local anaesthetic will be given, will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine

General anaesthesia will be managed in the same way for both groups

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients who are undergoing either laparoscopic or open colorectal resections will be considered eligible for the study.

Exclusion criteria

• Patients under 18 years of age.
• Pregnant females.
• Patients undergoing an abdominoperineal resection.
• Patients who will not contemplate being randomized to receive a spinal anaesthetic.
• Patients with a history of failure to place an epidural / spinal anaesthetic.
• Hypersensitivity to local anaesthetics.
• Lack of capacity to give consent.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups

Continuous infusion of local anaesthetic

Active Comparator group

Description:

Continuous infusion of local anaesthetic into the surgical wound

Treatment:

Drug: Bupivacaine

Device: A Painbuster® catheter

Procedure: Continuous infusion of local anaesthetic

Spinal and infusion of local anaesthetic

Experimental group

Description:

A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound

Treatment:

Device: 25G Whitacre needle

Drug: Diamorphine

Procedure: Spinal and infusion of local anaesthetic

Drug: Bupivacaine

Device: A Painbuster® catheter