Phase 3
N=80
Clinical Trial of the Use of Intraperitoneal Local Anaesthetic
Pain, Postoperative
Bottom Line
View on ClinicalTrials.gov: NCT00180687 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcome: Primary: Reduction in Postoperative Pain — 9.2; 10; 3.3; 9.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Nebulised Bupivacaine intraperitoneally (Drug); Normal Saline (Drug); Injected Bupivacaine intraperitoneally (Drug); No Intraperitoneal Therapeutics (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Sep 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Postoperative Pain |
9.2; 10; 3.3; 9.3; 8.2; 8.1 | — |
| SECONDARY Number of Vomiting / Nausea Episodes |
7.1; 7.1; 2; 6.8 | — |
| SECONDARY Hours Needed for Safe Mobilization |
6.7; 6.5; 3; 6.4 | — |
| SECONDARY Postoperative Morphine Use |
25.9; 26.3; 1; 16.7 | — |
Summary
Patients undergoing keyhole gall bladder removal will be divided into 3 groups, one control, one will have local anaesthetic and the third will have normal saline nebulised into their abdomen before closure of the wounds to reduce postoperative pain. These medications will be given on top of the standard pain management protocol.
Eligibility Criteria
Inclusion Criteria
- All they patients undergoing laparoscopic cholecystectomy will be included.
Exclusion Criteria
- Patients with local anaesthetic allergy, patients on chronic opiate medication or those with neurological diseases that make pain evaluation unreliable will be excluded.
Data sourced from ClinicalTrials.gov (NCT00180687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.