Prospective randomized trial to assess the efficacy of 0.5% Marcaine subserosal injection in the gall bladder fossa to reduce the post operative pain from laparoscopic cholecystectomy
| ISRCTN | ISRCTN68753145 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN68753145 |
| Protocol serial number | N0008171900 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | Frimley Park Hospital NHS Foundation Trust (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 06/09/2016
- 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 Amir Nisar
Scientific
Scientific
Portsmouth Road
Camberley
Camberley
GU16 7UJ
United Kingdom
| Phone | +44 (0)7859888713 |
|---|---|
| dranisar@yahoo.co.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 | Prospective randomized trial to assess the efficacy of 0.5% Marcaine subserosal injection in the gall bladder fossa to reduce the post operative pain from laparoscopic cholecystectomy |
| Study objectives | Pain after Laparoscopic Cholecystectomy (key hole removal of gall bladder) is much lower than an open operation for the removal of gall bladder. However one can still expect mild to moderate pain after the key hole operation. Can we reduce the post operative pain after the key hole operation by injecting local anaesthetic in the gall bladder bed? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Pain |
| Intervention | We will recruit every suitable patient who undergoes a Laparoscopic Cholecystectomy under either of the Upper Gastrointestinal Surgeons at Frimley Park Hospital. They will be given information leaflet about Laparoscopic cholecystectomy, and also given a leaflet with a diagram showing the site of injection. An informed consent will be taken for the study in addition to the standard consent form for the procedure. The surgeon will be unaware of the nature of the solution that he will inject into the gall bladder fossa (saline and bupivicaine injection will be shown to him pre op to check their details). A member of the team will draw an envelope to randomize the patients in either arm and will brief the nurse about the injection without the surgeon becoming aware of this Solution will be carefully injected with a 0.2 mm epidural needle connected to a syringe percutaneously in the subserosal area taking great care not to inject intravascularly. The rest of the operation will be performed as normal. Pain levels will be assessed at various periods after the operation and the results will be compared. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Marcaine |
| Primary outcome measure(s) |
Post operative pain scores |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 50 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/08/2005 |
| Date of final enrolment | 01/01/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Portsmouth Road
Camberley
GU16 7UJ
United Kingdom
GU16 7UJ
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
06/09/2016: No publications found, verifying study status with principal investigator.
