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 |
| Secondary identifying numbers | N0021108740 |
- 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
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 |
|---|---|
| philip.reginald@hwph-tr.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/03/2002 |
| Completion date | 01/05/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Heatherwood and Wexham Park Hospitals NHS Trust
Slough
SL2 4HL
United Kingdom
SL2 4HL
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Heatherwood and Wexham Park Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
04/04/2016: No publications found, verifying study status with principal investigator
