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Postoperative Analgesia After Total Hip Replacement

R

Rijnstate Hospital

Status and phase

Completed
Phase 3

Conditions

Total Hip Replacement

Treatments

Drug: intrathecal morphine AND patient controlled analgesia with iv morphine
Drug: Patient Controlled Analgesia with iv morphine and placebo
Drug: Intrathecal morphine at surgery, 0.1mg and placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00219921
LTC-349-030905

Details and patient eligibility

About

There are several treatments for postoperative pain after Hip Replacement Surgery. However, some require an intravenous line which may interfere with rehabilitation after surgery. This study aims to evaluate which method of pain treatment is best after Hip Replacement Surgery. Patients will either receive pain treatment at surgery, continuous intravenous pain treatment, or both. In the first two days after surgery, patients will frequently be asked to rate their pain, and use of other pain medication will be monitored.

Full description

This is a three-group randomized placebo-controlled double blind trial to assess which postoperative analgesia is best after total hip replacement. The conventional analgesia includes both intrathecal morphine at surgery and Patient Controlled Analgesia (PCA) with morphine in the first 48 hours after surgery. This will be compared with two experimental groups which will receive either intrathecal morphine and PCA with placebo or intrathecal placebo and PCA with morphine. Escape medication with intramuscular morphine is available in all groups. A total of 120 patients will be randomized.

VAS- score at rest and with movement will be recorded every three hours for the first 48 hours after surgery, as well as PCA-bolussum and Morphine IM.

Sex

All

Ages

30 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients accepted for fast-track total hip replacement, i.e.ASA 3 or lower

Exclusion criteria

  • Not able to speak dutch
  • communication problems
  • dementia
  • mental retardation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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