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Completed

NCT Number: NCT01764048

To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand

Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request).

The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses).

The protocols will be used for the first 48 hours following surgery.

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Key information

Conditions

Pain Management Agnosia Cesarean Section Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Departement of obstetric and gynecology, HaEmek medical center

Afula, 18101, Israel

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • women that underwent cesarean section

Exclusion criteria

  • Women suffering from chronic pain
  • Women using chronic pain medications
  • Allergy to any drug used in the study
  • Women underwent general anesthesia during the surgery
  • women with elevated liver enzymes

Treatment and study plan

Fix protocol

Drug

Please see arm description

medications following demand protocol

Drug

Please see arm description

Primary outcomes

  1. The efficacy of pain management

    Time frame: during 48 hours from surgery

    Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain

Secondary outcomes

  1. adverse effect of the medications given in each protocol

    Time frame: during 48 hours following surgery

  2. to compare the amount of breastfeeding between 2 groups

    Time frame: following the week after surgery

  3. The number of times that pain medications were given in each study group

    Time frame: during 48 hours following surgery

  4. The necessity of additional medications (rescue doses)

    Time frame: During 48 hours after surgery

  5. Patient satisfaction

    Time frame: 48 hours after surgery

    Each patient will fill in a satisfaction questioner which is given 48 hours after surgery

Sponsors and collaborators

Lead sponsor

HaEmek Medical Center, Israel

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2013
Registry last updated
Jan 8, 2016

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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