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

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

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: Bupivacaine; Procedure: Continuous infusion of local anaesthetic; Device: A Painbuster® catheter; Procedure: Spinal and infusion of local anaesthetic; Drug: Diamorphine; Device: 25G Whitacre needle

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

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • North Yorkshire
    • Scarborough, North Yorkshire, United Kingdom, YO12 6QL
      • Scarborough General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continuous infusion of local anaesthetic; Continuous infusion of local anaesthetic into the surgical wound	Drug: Bupivacaine; Procedure: Continuous infusion of local anaesthetic; 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.; Device: A Painbuster® catheter
Experimental: Spinal and infusion of local anaesthetic; A one off spinal anaesthetic plus a continuous infusion of local anaesthetic into the surgical wound	Drug: Bupivacaine; Device: A Painbuster® catheter; Procedure: Spinal and infusion of local anaesthetic; 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.; Drug: Diamorphine; 500mcg; Device: 25G Whitacre needle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroendocrine response to surgery	Peripheral blood samples taken at baseline, 60 minutes after surgical incision and 24 hours postoperatively will be analysed for cortisol and noradrenaline.	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay or fitness for discharge	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.	Up to 12 days
Postoperative complications	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.	Up to 12 days
Episodes of hypotension in the postoperative period	This will be defined as a sustained systolic blood pressure of less than 90 mm/Hg.	Up to 12 days
Postoperative pain	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.	Up to 72 hours after surgery
Postoperative analgesic requirement	The total quantity and type (opiate or non-opiate) of all analgesics administered for 72 hours postoperatively.	Up to 72 hours after surgery
Amount of postoperative IV fluid administered	Total amount of IV fluid given in postoperative period	Up to 12 days
Postoperative mobility	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.	Up to 12 days
Return of gut function	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	Up to 12 days
Oxidative stress	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.	For 24 hours
Inflammatory pathway	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.	Up to 24 hours after surgery

Collaborators and Investigators

• Sponsor: York Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Daniel Harper, MBChB, FRCA, York Teaching Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: July 31, 2014
• First Submitted That Met QC Criteria: August 5, 2014
• First Posted (Estimate): August 6, 2014

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Cancer; Pain relief; Colorectal
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Anesthetics; Anesthetics, Local; Bupivacaine; Heroin
• Other Study ID Numbers: SNE 2190