Which is the best analgesic method after an open cholecystectomy - a spinal or intercostal block?

Phase 1

• Conditions: Analgesia after open cholecystectomy.; MedDRA version: 14.1Level: PTClassification code 10008611Term: CholecystectomySystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2010-018548-15-SE
• Lead Sponsor: Anestesicentrum, Sundsvalls Sjukhus, Landstinget Västernorrland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-22
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1 Scheduled for open cholecystectomy at the study hospital.
2 Men and women >= 18 y.
3 ASA-classification I-III
4 Signed and dated informed consent.
5 The investigator anticipate that the patient are capable to conduct the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years)
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1 Childbearing or nursing women.
2 Allergies to drugs included in the study.
3 Contraindication for spinal blockade ( i e coagulopathy)
4 Contraindication for intercostalblock
5 Other reasons that the investigator find out is relevant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of the study is to evaluate differences in postoperative painrelief between general anestesia + spinalblock VS general anestesia + intercostal block for patients undergoing open cholecystectomy.;Secondary Objective: Secondary objectives are side effects to the analgesia as nausea, vomiting and time to discharge from the hospital.;Primary end point(s): Accumulated opioid consumption (total amout of morphine) at 1, 4, 12, 18, 24, 48 and 72 hours postoperatively.;Timepoint(s) of evaluation of this end point: Timepoints as stated in E5.1.<br><br>Time 0 is defined when the patient arrives at the recovery unit.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Painscores in rest and at cough.<br><br>Nausea since the previous timepoint?<br><br>Vomiting since the previos timepoint?<br><br>Time to ready to be discharged from the hospital as time after surgery.<br><br>Registrations for the above at the same timepoint as the primary endpoint.<br>;Timepoint(s) of evaluation of this end point: Timepoints as stated in E5.1.<br><br>Time 0 is defined when the patient arrives at the recovery unit.