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

Colorectal Cancer Clinical Trial

— PROSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02210260
• Other study ID #: SNE 2190
• Status: Completed
• Phase: N/A
• First received: July 31, 2014
• Last updated: September 13, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: September 2016
• Source: York Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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.
• 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.

Drug:
• Bupivacaine

• Diamorphine
500mcg

Device:
• A Painbuster® catheter

• 25G Whitacre needle

Locations

Country	Name	City	State
United Kingdom	Scarborough General Hospital	Scarborough	North Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
York Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Amount of postoperative IV fluid administered	Total amount of IV fluid given in postoperative period	Up to 12 days	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No