Comparison of Epidural Fentanyl and Clonidine for Breakthrough Pain
Condition: Labor Pain
MeSH terms: Labor Pain; Breakthrough Pain
Intervention: Clonidine; Fentanyl
Intervention description: Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.; Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
Intervention MeSH terms: Clonidine; Fentanyl
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will randomly receive either a mixture of 100 mcg of clonidine and 12.5 mg of bupivacaine for a total volume of 10 ml ("CLON" group) and the other group will receive 100 mcg of fentanyl and 12.5 mg of bupivacaine for a total volume of 10 ml ("FENT" group). If the treatment is declared a failure, the patient will receive the alternative of the initial treatment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Group assignment will be performed by opening a previously prepared numbered opaque envelope containing the assignment "CLO" or "FENT". The investigator preparing the study drug will not reveal the group assignment. The investigator administering the drug (different from the investigator preparing the drug) and assessing the outcomes will be blinded to the group assignment. The participant will also be blinded to the group assignment.
Enrollment: 101.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Analgesia; Epidural; Pregnancy; Labor; Clonidine; Fentanyl; Bupivacaine; Childbirth

Summary:

      Epidural analgesia has proven to be an effective method for severe pain relief associated
      with labor and delivery. During labor, a low dose continuous infusion of local anesthetic and
      narcotic will be administered through an epidural catheter. As labor progresses and the
      baby's head makes it way through the pelvis, breakthrough pain may emerge and often needs
      further treatment. The investigators provide pain relief by administering analgesics through
      the epidural catheter. The patients will be randomly assigned to receive one of two
      medication mixtures believed to be successful in treating this type of pain associated with
      advanced labor. After this initial treatment, if pain relief is not attained, the patient may
      receive the other medication as well. The medications used in this study have been used at
      this institution for some time and have been found to be safe for mother and baby. The opioid
      (fentanyl) dose is small and only a small fraction will be transmitted to the baby. The other
      medication (clonidine) better known as a blood pressure medication has also been used for
      pain relief. Studies and clinical experience have shown that clonidine when given epidurally
      in the doses used in this study has minimal, if any effect, on the blood pressure of the
      mother or of the baby. The investigators will record medical and obstetric history and labor
      progress relevant to the patient. The patient will be asked questions regarding labor pain
      and side effects before and after the analgesic is administered. The primary objective is to
      determine which treatment regimen is more successful in abolishing breakthrough pain in
      advanced labor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  women in labor at term pregnancy

          -  healthy

          -  epidural analgesia in place

          -  breakthrough pain in advanced labor

        Exclusion Criteria:

          -  chronic pain syndrome

          -  receiving systemic opioids within 4 hours

          -  receiving chronic antidepressants, clonidine, opioids