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

NCT01295138 | Unknown

• 1 other identifier: FIFEANAES1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Constipation; Abdominal Pain; Nausea; Vomiting

Keywords

Constipation; Caesarean section; Abdominal Pain; Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (2)

• Frequency of abdominal pain between lactulose and non-lactulose groups.

  First 5 days post Caesarean section.

• Frequency of nausea and vomiting between lactulose and non-lactulose groups

  First 5 days post-Caesarean

Study Arms (2)

Lactulose group

EXPERIMENTAL

Group receives 48 hours of lactulose post Caesarean section.

Drug: Lactulose

Non-lactulose group

NO INTERVENTION

Group receives no lactulose post Caesarean section.

Interventions

Lactulose DRUG

Lactulose liquid. 15mls twice daily

Also known as: Lactugal, Rectulose, Lactulose (non proprietry)

Lactulose group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• NHS Fife: lead

Study Sites (1)

Forth Park Hospital

Kirkcaldy, Fife, EH4 1QH, United Kingdom

Location

MeSH Terms

Conditions

Constipation; Abdominal Pain; Nausea; Vomiting

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Anthony Davis, MBCHB

  NHS Fife

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anthony Davis, MBCHB

CONTACT

anthonydavis@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: February 14, 2011
• Study Start: February 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: July 1, 2012
• Last Updated: February 23, 2011

Record last verified: 2010-12

Locations

GB (1)