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

NCT ID: NCT02210260

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-02-29

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

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Continuous infusion of local anaesthetic

Continuous infusion of local anaesthetic into the surgical wound

Group Type: ACTIVE_COMPARATOR

Continuous infusion of local anaesthetic

Intervention Type: 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

Intervention Type: DRUG

A Painbuster® catheter

Intervention Type: DEVICE

Spinal and infusion of local anaesthetic

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

Group Type: EXPERIMENTAL

Spinal and infusion of local anaesthetic

Intervention Type: 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.

Bupivacaine

Intervention Type: DRUG

Diamorphine

Intervention Type: DRUG

500mcg

A Painbuster® catheter

Intervention Type: DEVICE

25G Whitacre needle

Intervention Type: DEVICE

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Bupivacaine

Intervention Type: DRUG

Diamorphine

500mcg

Intervention Type: DRUG

A Painbuster® catheter

Intervention Type: DEVICE

25G Whitacre needle

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

York Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Harper, MBChB, FRCA

Role: PRINCIPAL_INVESTIGATOR

York Teaching Hospital NHS Foundation Trust

Locations

Scarborough General Hospital

Scarborough, North Yorkshire, United Kingdom

Countries

United Kingdom

Other Identifiers

SNE 2190

Identifier Type: -

Identifier Source: org_study_id