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NCT01090882
Efficacy of Intraperitoneal Local Anaesthetic Techniques During Laparoscopic Cholecystectomy: A Double Blind Randomized Controlled Trial
NA trial testing Bupivocaine in Gall Stones in 128 participants. Completed in 1 October 2009.
1 October 2009
Quick facts
| Lead sponsor | University Hospitals Coventry and Warwickshire NHS Trust |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | factorial |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 1 July 2009 |
| Primary completion | 1 October 2009 |
| Estimated completion | 1 October 2009 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Bupivocaine — full drug profile →
- 0.9% normal saline solution
Conditions studied
- Gall Stones — all drugs for Gall Stones →
Sponsor
University Hospitals Coventry and Warwickshire NHS Trust
Who can join
18 and older, any sex, with Gall Stones. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
VAS pain score
Time frame: 1, 4, 8 hours after operation and at discharge
Sponsor's own description
Pain following laparoscopic cholecystectomy (LC) results in morbidity and is a barrier to same day discharge. In several trials local anaesthetic (LA) washed over the liver and gall bladder decreases pain. In many patients pain has a strong component attributable to diaphragmatic origin. A wash of LA over the liver and gall bladder is unlikely to provide high levels of analgesia to pain fibres from the diaphragm. The investigators hypothesise that LA injected to the right hemidiaphragm during LC would be more effective than wash. Methods Double blind randomised controlled trial of 128 consecutive subjects undergoing elective LC. Control -sham injection of diaphragm and sham wash over liver/GB with saline; Test treatment 'subperitoneal LA' - bupivocaine injection/sham wash; Internal control 'topical LA' - sham injection/bupivocaine wash. Primary outcome: pain scores in theatre recovery and the ward. Secondary outcomes: analgesic use, physiological observations, time to eating and mobilising, day case surgery.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01090882
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01090882 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospitals Coventry and Warwickshire NHS Trust
- Last refreshed: 17 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01090882.
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