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

Spinal vs intercostal block for analgesia after open cholecystectomy - differences in postoperative pain? - Analgesia after open cholecystectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018548-15-SE

Enrollment

Registered

2010-03-22

Start date

2012-03-23

Completion date

Unknown

Last updated

2020-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia after open cholecystectomy. MedDRA version: 14.1 Level: PT Classification code 10008611 Term: Cholecystectomy System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Marcain Spinal 5 mg/ml Product Name: Marcain Spinal Product Code: - Pharmaceutical Form: Injection INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE CAS Number: 18010-40-7 Current Sponsor co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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. Time 0 is defined when the patient arrives at the recovery unit.	—

Measure

Time frame

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. Time 0 is defined when the patient arrives at the recovery unit.

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Secondary

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

Measure

Time frame

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

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Countries

Sweden

Contacts

Public ContactJakob Wallden

Anestesicentrum, Sundsvalls Sjukhus

jakob.wallden@lvn.se+46703644392

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026