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

Not Applicable

• Conditions: Constipation; Abdominal Pain; Nausea; Vomiting
• Interventions: Drug: Lactulose

• Registration Number: NCT01295138
• Lead Sponsor: NHS Fife

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-12
• Study First Submitted: 2010-12-30
• Study Start: 2011-02
• Study First Submitted QC: 2011-02-11
• Study First Posted: 2011-02-14
• Last Update Submitted: 2011-02-22
• Last Update Posted: 2011-02-23
• Primary Completion: 2012-02
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactulose group	Lactulose	Group receives 48 hours of lactulose post Caesarean section.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Frequency of abdominal pain between lactulose and non-lactulose groups.	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	First 5 days post-Caesarean	Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.

Trial Locations

Locations (1)

Forth Park Hospital; 🇬🇧 Kirkcaldy, Fife, United Kingdom