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

Study Overview
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Brief Summary
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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).

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

Conditions
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Constipation, Abdominal Pain, Nausea, Vomiting

Intervention / Treatment
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* Drug: Lactulose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactulose group<br>Group receives 48 hours of lactulose post Caesarean section. | Drug: Lactulose<br>* Lactulose liquid. 15mls twice daily<br>* Other names: Lactugal, Rectulose, Lactulose (non proprietry);|
| No Intervention: Non-lactulose group<br>Group receives no lactulose post Caesarean section. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Caesarean section, Abdominal Pain, Nausea, Vomiting