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Completed

NCT Number: NCT00219921

Postoperative Analgesia After Total Hip Replacement

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.

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Key information

Conditions

Total Hip Replacement Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

30 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intrathecal morphine at surgery, 0.1mg and placebo

Drug

Patient Controlled Analgesia with iv morphine and placebo

Drug

intrathecal morphine AND patient controlled analgesia with iv morphine

Drug

Primary outcomes

  1. VAS-score for pain at movement and at rest every three hours

  2. PCA-bolus-sum every three-hour period

  3. Morphine-IM rescue dose every three-hour period

Secondary outcomes

  1. patient satisfaction each 24 hours

  2. iv-morphine dose needed to attain VAS-score under 40 mm

  3. PONV every three hours

  4. urine retention every three hours

  5. itching every three hours

  6. decrease in saturation every three hours

  7. quality of physical training

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Sep 22, 2005
Registry last updated
Mar 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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