Post operative pain control after abdominal gynaecological surgery using pump-releasing local anaesthetic for 24 hours continuously

ISRCTN	ISRCTN28558391
DOI	https://doi.org/10.1186/ISRCTN28558391
Protocol serial number	N0021108740
Sponsor	Department of Health
Funder	Heatherwood and Wexham Park Hospitals NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 04/04/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

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

Contact information

Mr Philip Reginald
Scientific

Heatherwood and Wexham Park Hospitals NHS Trust
Department of Obstetrics & Gynaecology
Wexham Park Hospital
Slough
SL2 4HL
United Kingdom

Phone	+44 (0)1753 634509
Email	philip.reginald@hwph-tr.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Post operative pain control after abdominal gynaecological surgery using pump-releasing local anaesthetic for 24 hours continuously: a prospective, double-blind, randomised, placebo-controlled study
Study objectives	To evaluate whether administering local anaesthetic to the wound area using an infiltration catheter, with a pump releasing system, for 24 hours following surgery will reduce the amount of post operative pain experienced by patients, their opioid consumption and subsequent delayed gastric emptying.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Pain
Intervention	The surgery will be performed under general anaesthetic induced with fentanyl and propofol. Vecuronium will be administered to facilitate tracheal intubation and for neuromuscular block during surgery. Diclofenac 100 mg will be administered per rectum at the end of the operation. Before the wound is closed a single infiltration catheter which is 1.2 mm in diameter with 90 side holes will be placed between the rectus sheath and subcutaneous layer along the transverse incision. Following the operation patients will be randomised into either an experimental or placebo controlled group using computer generated random numbers. Those in the experimental group will receive marcain 0.5% every 4 hours for 24 hours through the catheter. The placebo controlled group will receive Na-Saline in the same regime. Post-operatively, if patients complain of pain or ask for analgesics morphine will be administered and recorded using a PCA (patient controlled analgesia) device. The patients' pain will be assessed 4, 8, 12, 24, 36, 48 and 72 hours post operatively, at rest during coughing and when mobilising from supine to sitting position in bed. Gastric emptying will also be monitored. Any complication including wound infection will be recorded.
Intervention type	Other
Primary outcome measure(s)	1. Post operative pain at 4, 8, 12, 24, 36, 48 and 72 hours while at rest, coughing and mobilising from supine to sitting position in bed, assessed using a 10 point visual analogue scale. 2. Gastric emptying will be recorded on a trial sheet. 3. Opioid consumption will be recorded using the Patient Controlled Analgesia device and included on the trial sheet for 3 days post op.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/05/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	80
Key inclusion criteria	80 women aged 30 to 70 years undergoing elective gynaecological surgery performed through a transverse incision in the lower abdomen.
Key exclusion criteria	1. Patients with a known allergy to morphine, fentanyl, propofol, vecuronium, diclofenac or marcain. 2. Regular medication with opioids for the last 6 months. 3. Body mass index (BMI) greater or equal to 32. 4. Previous major surgery during the last 6 months.
Date of first enrolment	01/03/2002
Date of final enrolment	01/05/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Heatherwood and Wexham Park Hospitals NHS Trust

Slough
SL2 4HL
United Kingdom

Results and Publications

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

Study outputs

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

Editorial Notes

04/04/2016: No publications found, verifying study status with principal investigator