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Completed

NCT Number: NCT02210260

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scarborough General Hospital

Scarborough, North Yorkshire, YO12 6QL, United Kingdom

About this study

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

  • better pain relief
  • 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

  • A single shot of spinal anaesthesia plus a continuous infusion of local anaesthetic into the surgical wound or
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinal and infusion of local anaesthetic

Procedure

Spinal anaesthetic 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.

PLUS

Painbuster® catheters 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.

Continuous infusion of local anaesthetic

Procedure

A Painbuster® catheter 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.

Bupivacaine

Drug

Diamorphine

Drug

500mcg

A Painbuster® catheter

Device

25G Whitacre needle

Device

Primary outcomes

  1. Neuroendocrine response to surgery

    Time frame: 24 hours

    Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for cortisol and noradrenaline.

Secondary outcomes

  1. Length of hospital stay or fitness for discharge

    Time frame: Up to 12 days

    Discharge criteria:

    • Good pain control with oral analgesia.
    • Tolerating solid food without nausea and vomiting.
    • No IV fluid or medication.
    • Independently mobile and self-caring or at the same level as prior to admission.
    • Stable observations and blood biochemistry.
    • No other concerns or complications preventing discharge.

  2. Postoperative complications

    Time frame: Up to 12 days

    All complications in the postoperative period will be recorded. Particular emphasis will be given to:

    Wound infection

    Cardiac failure:

    Complications related to spinal anaesthesia.

    Adequacy of deep vein thrombosis prophylaxis.

  3. Episodes of hypotension in the postoperative period

    Time frame: Up to 12 days

    This will be defined as a sustained systolic blood pressure of less than 90 mm/Hg.

  4. Postoperative pain

    Time frame: Up to 72 hours after surgery

    This will be assessed using a visual analogue scale . Measurements will be taken in recovery then once a day for 72 hours postoperatively. Pain scores will be measured at rest and on coughing.

  5. Postoperative analgesic requirement

    Time frame: Up to 72 hours after surgery

    The total quantity and type (opiate or non-opiate) of all analgesics administered for 72 hours postoperatively.

  6. Amount of postoperative IV fluid administered

    Time frame: Up to 12 days

    Total amount of IV fluid given in postoperative period

  7. Postoperative mobility

    Time frame: Up to 12 days

    Postoperative mobility will be assessed as

    time until able to stand aided and unaided,

    duration of time spent out of bed on each postoperative day

    maximum walking distance with assistance on a daily basis.

  8. Return of gut function

    Time frame: Up to 12 days

    4.2.8 Time to return of gut function This is defined by the oral/enteral tolerance of > 80% of nutritional requirement.

    These requirements will be assessed individually for each patient in the study by an appropriately trained dietician

  9. Oxidative stress

    Time frame: For 24 hours

    Peripheral blood samples will be taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively and analysed for heat shock proteins 37 and 32.

  10. Inflammatory pathway

    Time frame: Up to 24 hours after surgery

    Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for IL1.

    Peritoneal biopsies taken prior to closure of surgical wound and analysed for IL1.

Sponsors and collaborators

Lead sponsor

York Teaching Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Pain Relief After Colorectal Surgery: Single-shot Spinal Combined With Painbuster® vs Painbuster® Alone. A Pilot Randomised Controlled Trial

Acronym: PROSP

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2014
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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