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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01295138
• Other study ID #: FIFEANAES1
• Status: Not yet recruiting
• Phase: N/A
• First received: December 30, 2010
• Last updated: February 22, 2011
• Start date: February 2011
• Est. completion date: July 2012

Study information

• Verified date: December 2010
• Source: NHS Fife
• Contact: Anthony Davis, MBCHB
• Email: anthonydavis[@]nhs.net
• Is FDA regulated: No
• Health authority: United Kingdom: Department of HealthUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Pain
• Constipation
• Nausea
• Vomiting

Intervention

Drug:
• Lactulose
Lactulose liquid. 15mls twice daily

Locations

Country	Name	City	State
United Kingdom	Forth Park Hospital	Kirkcaldy	Fife

Sponsors (1)

Lead Sponsor	Collaborator
NHS Fife

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in hours to passage of first stool post Caesarean Section.	Time (hours) to first bowel motion post elective LSCS betwwen Lactulose and non-Lactulose groups.	First 5 days post Caesarean section.	No
Secondary	Frequency of abdominal pain between lactulose and non-lactulose groups.	Frequency of abdominal pain between lactulose and non-lactulose groups post Caesarean Section.	First 5 days post Caesarean section.	No
Secondary	Frequency of nausea and vomiting between lactulose and non-lactulose groups	Frequency of nausea and vomiting between lactulose and non-lactulose groups post Caesarean Section.	First 5 days post-Caesarean	No