Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation

Overview

Constipation following elective Caesarean sections (CS) is a common problem experienced by up to 50% of patients (1). The causes for this are multifactorial and include manipulation of the bowel during surgery, immobilisation and opiate based anaesthetic and analgesic techniques. To try to alleviate the problem of postoperative constipation, some anaesthetists prescribe postoperative lactulose in addition to postoperative analgesia, although no data exists that shows whether this has any beneficial effect on postoperative constipation. 1. Short term morbidity associated with Caesarean delivery. Hillan EM. Birth. 19 (4): 190-4).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2012

Interventions

  • Drug: Lactulose
    • Lactulose liquid. 15mls twice daily

Arms, Groups and Cohorts

  • Experimental: Lactulose group
    • Group receives 48 hours of lactulose post Caesarean section.
  • No Intervention: Non-lactulose group
    • Group receives no lactulose post Caesarean section.

Clinical Trial Outcome Measures

Primary Measures

  • Time in hours to passage of first stool post Caesarean Section.
    • Time Frame: First 5 days post Caesarean section.
    • Time (hours) to first bowel motion post elective LSCS betwwen Lactulose and non-Lactulose groups.

Secondary Measures

  • Frequency of abdominal pain between lactulose and non-lactulose groups.
    • Time Frame: First 5 days post Caesarean section.
    • Frequency of abdominal pain between lactulose and non-lactulose groups post Caesarean Section.
  • Frequency of nausea and vomiting between lactulose and non-lactulose groups
    • Time Frame: First 5 days post-Caesarean
    • Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.

Participating in This Clinical Trial

Inclusion Criteria

  • All patients aged 16 years or older able to give informed consent undergoing their first or second elective CS Exclusion Criteria:

  • Unable to give informed consent – A basic level of literacy sufficient to complete postoperative form. – History of constipation – Regular opiate use – Previous bowel surgery or bowel adhesions – Lactose intolerant – Diabetic – Any patient unable to have spinal Anaesthesia – Allergies/intolerant to bupivacaine, diamorphine, diclofenac, cocodamol, lactulose – Patients receiving injury to bowel intraoperatively – Patients receiving additional opiates perioperatively

Gender Eligibility: Female

Minimum Age: 16 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NHS Fife
  • Provider of Information About this Clinical Study
    • Dr Anthony Davis Consultant Anaesthetist, NHS Fife
  • Overall Official(s)
    • Anthony Davis, MBCHB, Principal Investigator, NHS Fife
  • Overall Contact(s)
    • Anthony Davis, MBCHB, anthonydavis@nhs.net

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