Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
04/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Philip Reginald

ORCID ID

Contact details

Heatherwood and Wexham Park Hospitals NHS Trust
Department of Obstetrics & Gynaecology
Wexham Park Hospital
Slough
SL2 4HL
United Kingdom
+44 (0)1753 634509
philip.reginald@hwph-tr.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0021108740

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2002

Overall trial end date

01/05/2003

Reason abandoned

Eligibility

Participant inclusion criteria

80 women aged 30 to 70 years undergoing elective gynaecological surgery performed through a transverse incision in the lower abdomen.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

80

Participant 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.

Recruitment start date

01/03/2002

Recruitment end date

01/05/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Heatherwood and Wexham Park Hospitals NHS Trust
Slough
SL2 4HL
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Heatherwood and Wexham Park Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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