CAMELOT - Continuous rectus sheath Analgesia in eMErgency LaparOTomy

Plain English Summary

Background and study aims
In the UK around 30,000 patients, a year undergo an operation called an emergency laparotomy to treat life-threatening conditions. A large vertical cut is made in the abdomen when patients are asleep under general anesthesia. Good pain relief after surgery will help patients feel better and recover quicker. Because of the high level of pain experienced by many patients, opioid-based painkillers such as morphine are often given, using patient-controlled analgesia (PCA) pumps. However, morphine can cause serious side effects such as breathing problems, nausea and vomiting, and delayed bowel movement, which can slow patient recovery. Rectus sheath catheters (RSCs) are a newer way of providing pain relief, where two thin tubes (catheters) are inserted on either side of the wound during the operation. Local anesthetic is injected slowly into the catheters to numb the nerves and reduce pain for about three days. Small studies suggest that RSCs may provide effective pain relief, reduce the use of morphine, and help patient recovery. Potential disadvantages are that RSCs take time to insert and are expensive. More work is needed to understand whether there are any unwanted effects with RSCs.

This study will find out whether adding a RSCs to standard patient-controlled analgesia provides better pain relief, fewer side effects and complications, and greater satisfaction for patients undergoing emergency laparotomy compared to a control group who will receive a sham catheter with no infusion of analgesia. Our study will also aim to determine whether RSCs are safe and cost-effective.

Who can participate?
Adults who are due to undergo emergency laparotomy surgery.

What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin). An active Rectus Sheath Catheter (RSC) with a constant infusion of local anesthesia for 72 h from the end of surgery will be given to one group of participants. The other group will receive a sham rectus sheath catheter with an inactive infusion device in place for 72 h from the end of surgery. Participants and researchers will not have a choice in which of the two treatments will be given to each participant and will not know which treatment participants have received during the study.

What are the possible benefits and risks of participating?
The benefits of the CAMELOT study are that we hope that patients will have less pain after their operation and that their recovery/discharge time may be quicker.

The risks for participating in the CAMELOT study are associated with the ‘active’ rectus sheath catheter and are extremely rare. Particpiants will be actively monitored throughout the study for any possible side effects. Some of the rare risks are described below:
1. Disconnection. Occasionally the RSCs may become accidentally disconnected from the pump. If this happens, we will remove the RSCs to prevent infection, and you will be able to have other forms of pain relief.
2. Infection. This will be actively monitored by the participant’s clinician who will treat accordingly and remove the RSC.
3. Bleeding. This will be actively monitored by the participant’s clinician who will treat accordingly and remove the RSC.

Where is the study run from?
University Hospital Southampton NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
From January 2022 to October 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) Health Technology Assessment (HTA) programme (UK)

Who is the main contact?
Jonathan Evans, camelot-trial@bristol.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

University Hospital Southampton NHS Foundation Trust
Hospital/treatment centre

R&D Department
University Hospital Southampton NHS Foundation Trust
Level E, Laboratory & Pathology Block
SCBR - Mailpoint 138
Tremona Road
Southampton
SO16 6YD
England
United Kingdom

Phone	+44 (0)2381205146
Email	sharon.davies-dear@uhs.nhs.uk
Website	http://www.uhs.nhs.uk/home.aspx
"ROR"	https://ror.org/0485axj58

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN15475290 CAMELOT_Protocol_v1.0_01July2022.pdf

ISRCTN15475290_Protocol_v2.0_12April2023.pdf

Editorial Notes

04/09/2023: The following changes were made:
1. The public contact was changed.
2. Medway NHS Foundation Trust was added as a study participating centre.
22/06/2023: The study participating centre 'Heartlands Hospital' was added.
03/05/2023: Uploaded protocol (not peer reviewed)
24/02/2023: The following changes have been made:
1. Ethics approval added.
2. The participant exclusion criteria have been changed.
3. The recruitment start date has been changed from 01/11/2022 to 25/01/2023.
22/12/2022: The following changes have been made:
1. Uploaded protocol (not peer reviewed)
2. The public contact has been changed and the plain English summary updated accordingly.
29/09/2022: The recruitment start date was changed from 01/09/2022 to 01/11/2022.
05/09/2022: Internal review.
04/08/2022: Trial’s existence confirmed by the National Institute for Health and Care Research.