PROTECT-AEGIS
Research type
Research Study
Full title
Analgesia with ibuprofen for patients undergoing elective major Gastro-Intestinal Surgery
IRAS ID
1011239
Contact name
Tom Abbott
Contact email
Sponsor organisation
Queen Mary University of London
ISRCTN Number
ISRCTN18046426
Research summary
After the participant's operation, they will receive one of two study treatments, either ibuprofen and standard pain control or only standard pain control. Standard pain control usually involves morphine-like medicines, and local anaesthetic which can be placed straight into the surgical wound, or given through an epidural. Paracetamol is also widely used. This decision will be made at random and neither the participant nor their doctor will be able to decide which study treatment they receive. If participants are in the ibuprofen group, they will be given ibuprofen along with standard pain control and all their usual medications for five days after surgery. In the standard care group, participants will receive the standard pain management for their hospital without ibuprofen. If participants are in the ibuprofen arm, they will also receive medication to prevent stomach ulcers. All of their other treatments will be the same regardless of which study treatment they get. Their doctors at the hospital will be aware that they are in this study and will be closely monitored throughout their hospital stay. If necessary, adjustments to their treatment will be made to make sure they are safe. The GP will also be informed of their participation in the study so they are aware the patient might have received ibuprofen during their hospital stay. Participants will also be asked some questions about their health before and after their operation, which will be online or by telephone if at home, and face to face if they still in hospital. We will record information about any pain they experience on the first five days after surgery, which will take about two minutes each day. If participants have a carer or proxy, they would be welcome to help answer these questions. The last time we contact participants will be 30 days after their operation.
REC name
London - South East Research Ethics Committee
REC reference
24/LO/0885
Date of REC Opinion
3 Feb 2025
REC opinion
Further Information Favourable Opinion