Clinical trial NCT02210260: Pain Relief After Colorectal Surgery: Spinal Combined With Painbuster® vs Painbuster® Alone.
Official title: Pain Relief After Colorectal Surgery: Single-shot Spinal Combined With Painbuster® vs Painbuster® Alone. A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Cancer
Colorectal
Pain relief
Lead sponsor: York Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2014-08-06
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Neuroendocrine response to surgery
timeFrame: 24 hours
Secondary outcomes:
measure: Length of hospital stay or fitness for discharge
timeFrame: Up to 12 days
measure: Postoperative complications
timeFrame: Up to 12 days
measure: Episodes of hypotension in the postoperative period
timeFrame: Up to 12 days
measure: Postoperative pain
timeFrame: Up to 72 hours after surgery
measure: Postoperative analgesic requirement
timeFrame: Up to 72 hours after surgery
measure: Amount of postoperative IV fluid administered
timeFrame: Up to 12 days
measure: Postoperative mobility
timeFrame: Up to 12 days
measure: Return of gut function
timeFrame: Up to 12 days
measure: Oxidative stress
timeFrame: For 24 hours
measure: Inflammatory pathway
timeFrame: Up to 24 hours after surgery
Other outcomes:
Locations:
city: Scarborough
country: United Kingdom
facility: Scarborough General Hospital
state: North Yorkshire
Study officials:
affiliation: York Teaching Hospital NHS Foundation Trust
name: Daniel Harper, MBChB, FRCA
role: PRINCIPAL_INVESTIGATOR
References: