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Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

Primary Purpose

Cholecystolithiasis

Status

Unknown status

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

Gabapentin

S-ketamine

Lidocaine

Droperidol

About this trial

This is an interventional treatment trial for Cholecystolithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Dept of Anaesthesia, Hvidovre Hospital

Outcomes

Primary Outcome Measures

1. postoperative abilities over time in PACU

2. discharge time from PACU according to fixed criteria

3. consumption of analgesics and antiemetics in the PACU

Secondary Outcome Measures

1. Degree of nursing requirements in the PACU

2. General tolerability of the regimens

Full Information

NCT ID

NCT00209885

First Posted

September 14, 2005

Last Updated

September 14, 2005

Sponsor

Hvidovre University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00209885

Brief Title

Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2005

Overall Recruitment Status

Unknown status

Study Start Date

October 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hvidovre University Hospital

4. Oversight

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cholecystolithiasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

60 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Gabapentin

Intervention Type

Drug

Intervention Name(s)

S-ketamine

Intervention Type

Drug

Intervention Name(s)

Lidocaine

Intervention Type

Drug

Intervention Name(s)

Droperidol

Primary Outcome Measure Information:

Title

1. postoperative abilities over time in PACU

Title

2. discharge time from PACU according to fixed criteria

Title

3. consumption of analgesics and antiemetics in the PACU

Secondary Outcome Measure Information:

Title

1. Degree of nursing requirements in the PACU

Title

2. General tolerability of the regimens

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kenneth Jensen, M.D.

Phone

+45 36 32 62 90

kenneth.jensen@hh.hosp.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kenneth Jensen, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Claus Lund, dr.med.sci

Organizational Affiliation

Dept of Anaesthesia, Hvidovre Hospital, Copenhagen, Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Dept of Anaesthesia, Hvidovre Hospital

City

Copenhagen

State/Province

Hvidovre

ZIP/Postal Code

2650

Country

Denmark

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kenneth Jensen, M.D.

Phone

+45 36 32 62 90

kenneth.jensen@hh.hosp.dk

First Name & Middle Initial & Last Name & Degree

Kenneth Jensen, M.D.

12. IPD Sharing Statement

Links:

URL

http://www.postoppain.org

Description

URL looking into anaesthesia and surgery for cholecystectomy

Learn more about this trial

Optimal Multimodal Analgesia in Laparoscopic Cholecystectomy

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