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

NHS Fife

Status: Unknown

Conditions: Vomiting; Nausea; Constipation; Abdominal Pain

Treatments: Drug: Lactulose

Study type: Interventional

Funder types: Other

Identifiers

NCT01295138

FIFEANAES1

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Lactulose group

Experimental group

Description:

Group receives 48 hours of lactulose post Caesarean section.

Treatment:

Drug: Lactulose

Non-lactulose group

No Intervention group

Description:

Group receives no lactulose post Caesarean section.