The morphine-sparing effect of continuous intra-articular infusion of bupivacaine following knee arthroplasty - a randomised double-blind placebo-controlled trial

ISRCTN	ISRCTN62584127
DOI	https://doi.org/10.1186/ISRCTN62584127
Protocol serial number	N0009109897
Sponsor	Department of Health (UK)
Funder	Gateshead Health NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Philip Mathew
Scientific

Anaesthetic Department
Gateshead Health NHS Trust
Queen Elizabeth Hospital
Sheriff Hill
Gateshead
NE9 6SX
United Kingdom

Phone	+44 (0)191 403 2046

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	The continuous infusion of bupivacaine intraarticularly will decrease the postoperative morphine requirement following knee arthroplasty surgery.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Pain
Intervention	60 patients scheduled to undergo primary knee replacement will be divided into two groups of 30 each. All of them will receive spinal anaesthesia for the surgical procedure and at the end of the procedure, a 18 G epidural catheter will be inserted into the joint aseptically. Both the groups will receive a continuous infusion of either 0.25% bupicacaine or normal saline respectively into the joint for 48 h in the postoperative period. All of them will receive morphine PCA postoperatively for analgesia along with non-steroidal anti-inflamatory agents as per protocol. The prospective pain relief, morphine and other analgesic requirements will be assessed. The side effects, if any, will be noted. The results will be analysed statistically.
Intervention type	Other
Primary outcome measure(s)	Pain score, sedation score, PCA morphine consumption and co-analgesic consumption will be noted postoperatively at regular intervals.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/07/2003

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	The study population will consist of patients admitted by the Department of Orthopaedics, QEH, for unilateral primary knee arthroplasty who are willing to take part in the study
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/09/2001
Date of final enrolment	31/07/2003

Anaesthetic Department

Gateshead
NE9 6SX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes