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

NCT02210260 | Completed

• 1 other identifier: SNE 2190
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Cancer; Colorectal; Pain relief

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Length of hospital stay or fitness for discharge

  Up to 12 days

• Postoperative complications

  Up to 12 days

• Episodes of hypotension in the postoperative period

  Up to 12 days

• Postoperative pain

  Up to 72 hours after surgery

• Postoperative analgesic requirement

  Up to 72 hours after surgery

Study Arms (2)

Continuous infusion of local anaesthetic

ACTIVE COMPARATOR

Continuous infusion of local anaesthetic into the surgical wound

Procedure: Continuous infusion of local anaesthetic; Drug: Bupivacaine; Device: A Painbuster® catheter

Spinal and infusion of local anaesthetic

EXPERIMENTAL

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

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

Interventions

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.

Spinal and infusion of local anaesthetic

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.

Continuous infusion of local anaesthetic

Bupivacaine DRUG

Continuous infusion of local anaesthetic; Spinal and infusion of local anaesthetic

Diamorphine DRUG

500mcg

Spinal and infusion of local anaesthetic

A Painbuster® catheter DEVICE

Continuous infusion of local anaesthetic; Spinal and infusion of local anaesthetic

25G Whitacre needle DEVICE

Spinal and infusion of local anaesthetic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• York Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Scarborough General Hospital

Scarborough, North Yorkshire, YO12 6QL, United Kingdom

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Neoplasms

Interventions

Bupivacaine; Heroin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Daniel Harper, MBChB, FRCA

  York Teaching Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 6, 2014
• Study Start: September 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

GB (1)