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20/22 Rectus sheath blockade in emergency laparotomy

 

Contents

Introduction

The aim of the HTA Programme is to ensure that high quality research information on the effectiveness, costs and broader impact of health technology is produced in the most efficient way for those who use, manage, provide care in or develop policy for the NHS. Topics for research are identified and prioritised to meet the needs of the NHS. Health technology assessment forms a substantial portfolio of work within the National Institute for Health Research and each year about fifty new studies are commissioned to help answer questions of direct importance to the NHS. The studies include both primary research and evidence synthesis.

Research Question:

What is the clinical and cost-effectiveness of rectus sheath blockade in emergency laparotomy? 

  1. Intervention: Rectus sheath blockade with catheter plus treatment as usual. 
  2. Patient group: Adults undergoing emergency laparotomy - to be defined and justified by applicants.
    Applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity in this field.
  3. Setting: Hospital.
  4. Comparator: Treatment as usual i.e. patient-controlled analgesia using systemic opioids e.g. morphine. 
  5. Study design: A randomised controlled trial with an internal pilot phase to test the ability to recruit and randomise. Clear stop/go criteria should be provided to inform progression from pilot to full trial.
  6. Important outcomes: To be defined and justified by applicants that should include a trade-off between potential benefits and harms. For example post-operative pain; time to mobilisation; adverse effects including complications associated with catheters and post-operative pulmonary complications; return of bowel function.
    Other outcomes: Mortality at 30 days; opioid use; health related quality of life; cost-effectiveness; length of post-operative hospital stay; patient acceptability.
    Where established Core Outcomes exist, they should be included amongst the list of outcomes unless there is good reason to do otherwise.
  7. Minimum duration of follow-up: 30 days. 

Rationale:

In the UK, tens of thousands of patients each year undergo a major surgical operation called an emergency laparotomy to treat an acute life-threatening problem within the abdomen. During the procedure, a large, vertical incision is made into the abdomen to allow the surgeon to diagnose and treat many serious conditions including internal bleeding, sepsis or a blockage to the bowel. Whilst the vertical (also known as midline) incision provides quick and easy access to the abdominal cavity, it transects the nerves crossing the abdominal wall, increasing post-operative pain, hindering early recovery and discharge.

Intravenous, morphine-based, patient-controlled analgesia is used to treat post-operative pain following emergency laparotomy. It involves administration of a programmed dose of analgesics, while also allowing patients to receive additional, need-based doses at a particular time when pain is likely to increase. Morphine has many side effects, including nausea, constipation and respiratory depression, which are associated with slower recovery and discharge times.

To overcome the side effects associated with morphine use, an alternative for post-operative pain relief, known as a rectus sheath block, is increasingly being used in practice, which works by blocking the nerves in the abdomen using local anaesthetic. A catheter is inserted into the rectus sheath, which is made up of fibres from the three abdominal muscles, allowing local anaesthetic to be continuously infused, providing long-lasting analgesia.

Despite the increased use of rectus sheath blocks in the NHS there is only limited prospective clinical trial data. The evidence to date comes from small, biased studies that commonly focus on both elective and emergency laparotomies. Findings from these studies are promising and suggest that rectus sheath block analgesia may provide effective post-laparotomy pain relief and reduce opioid use, thereby reducing recovery and discharge time. However, there is clinical uncertainty over whether rectus sheath catheters can lead to complications such as wound infections and sepsis, and whether they inhibit the time to mobilisation post-surgery. An adequately powered, unbiased RCT is required.

An NIHR funded study containing information of some relevance to this call has completed but is as yet unpublished. If you are applying to this call you may request a confidential version of the Research for Patient Benefit report (PB-PG-0212-27122) by contacting htafunding@nihr.ac.uk

Additional commissioning brief background information

A background document is available that provides further information to support applicants for this call. It is intended to summarise what prompted the call and the existing evidence base, including relevant work from the HTA and wider NIHR research portfolio. It was researched and written on the basis of information from a search of relevant sources and databases, and in consultation with a number of experts in the field. If you would like a copy please email htaresearchers@nihr.ac.uk.

Making an application

If you wish to submit a Stage 1 application for this call, the online application form can be found on the Funding opportunities page. To select this call, use the filters on the right of the screen or search using the call name and/or number.

Your application must be submitted on-line no later than 1pm on the 2nd December 2020. Applications will be considered by the HTA Funding Committee at its meeting in January 2021.

Guidance notes and supporting information for HTA Programme applications are available by clicking the links.

IMPORTANT: Shortlisted Stage 1 applicants will be given eight weeks to submit a Stage 2 application. The Stage 2 application will be considered at the Funding Committee in May 2021.

Applications received electronically after 1300 hours on the due date will not be considered.

Should you have any queries please contact us:

Email:

htacommissioning@nihr.ac.uk

Telephone:

Commissioning Funding Committee 02380 595510