Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

NCT ID: NCT00209885

Last Updated: 2005-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Brief Summary

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To test the current standard of care (SOC) treatment for laparoscopic cholecystectomy with a group receiving SOC + additional perioperative analgesics in terms of postoperative abilities, PONV, pain and discharge time from the PACU

Detailed Description

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Aim of the study: to compare postoperative complaints (PONV, pain, etc) and PACU discharge time between two groups:

* A: standard of care (SOC)receiving intraoperative dexamethasone, ondansetron, ketorolac, and general anaesthesia with propofol, remifentanil and cisatracurium
* B: SOC + preoperative gabapentin, intraoperative lidocain infusion, s-ketamin and droperidol.

Primary endpoints:

* postoperative abilities over time
* discharge time from PACU according to fixed criteria
* consumption of analgesics and antiemetics in the PACU

Secondary endpoints:

* degree of nursing requirements at the PACU
* General tolerability of the regimes

Conditions

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Cholecystolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Gabapentin

Intervention Type DRUG

S-ketamine

Intervention Type DRUG

Lidocaine

Intervention Type DRUG

Droperidol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Elective laparoscopic cholecystectomy
* Age above 18 years
* Written informed consent
* ASA class I-III

Exclusion Criteria

* Planned abdominal cholecystectomy
* Intraoperative conversion of laparoscopic to laparotomic cholecystectomy
* Allergy to part of the treatment regimens
* Previous reactions to opioids (nausea, cognition)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Kenneth Jensen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Dept of Anaesthesia, Acute Pain Service, Hvidovre Hospital, Copenhagen, Denmark

Claus Lund, dr.med.sci

Role: STUDY_CHAIR

Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark

Locations

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Dept of Anaesthesia, Hvidovre Hospital

Copenhagen, Hvidovre, Denmark

Site Status

Countries

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Denmark

Central Contacts

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Kenneth Jensen, M.D.

Role: CONTACT

Phone: +45 36 32 62 90

Email: [email protected]

Facility Contacts

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Kenneth Jensen, M.D.

Role: primary

Related Links

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http://www.postoppain.org

URL looking into anaesthesia and surgery for cholecystectomy

Other Identifiers

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OMA-LC01

Identifier Type: -

Identifier Source: org_study_id