Post-operative Emesis and Pain Outcomes After Cesarean Delivery (EPOC)

KK Women's and Children's Hospital

Status: Active, not recruiting

Conditions: Cesarean Section; Vomiting, Postoperative; Pain, Postoperative; Nausea, Postoperative

Treatments: Other: Questionnaires; Other: Preoperative pain assessment; Other: Headspace; Procedure: Mechanical Temporal Summation assessment

Study type: Observational

Funder types: Other

Identifiers

NCT03645239

ANAESPRG18/02

Details and patient eligibility

About

Approximately 20% women who undergo cesarean delivery would suffer from severe post-operative pain, which may further increase their risks from developing postpartum depression. Predictive factors such as pre-operative pain, age and anxiety could significantly contribute to post-operative nausea and vomiting (PONV) and pain in general surgery, however little information is available with regards to cesarean delivery. The investigators would investigate the risk factors of causing post-operative emesis after cesarean delivery, and to reaffirm that there is a positive correlation between pain on local anesthetic injection, presence of mechanical temporal summation (MTS) and post-Cesarean pain scores.

Full description

Previous studies demonstrated that pain scores upon local anesthetic injection is positively correlated to post-cesarean pain scores. Anxiety, anticipated post-operative pain score and anticipated medication need are also found to be promising risk factors to post-cesarean pain management.

The investigators would investigate the risk factors of causing post-cesarean emesis, and to reaffirm that there is a positive correlation between pain on local anesthetic injection, presence of mechanical temporal summation (MTS) and post-Cesarean pain scores. 470 parturients undergoing cesarean delivery and requiring regional anaesthesia will be recruited. Pain and anxiety assessment will be conducted via visual analogue scoring (VAS), MTS assessment and a series of questionnaires. After delivery, patients will be given appropriate analgesia, and pain score at movement will be recorded. Secondary outcomes include pain scores at rest, analgesia consumption, time-to-first-rescue analgesia, opioid-related side effects, patient satisfaction and postpartum depression. A separate 125 patients will be recruited to evaluate the feasibility and patient acceptability of the use of Headspace, a mindfulness mobile application during the pre- and postnatal period to improve the maternal outcomes (emesis, pain, anxiety, depression).

Enrollment: 595 estimated patients

Sex: Female

Ages: 21 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant and going to have caesarean delivery (36 weeks gestation or more; nulliparous and multiparous);
• Healthy or have mild medical problems that are well-controlled (American Society of Anesthesiologists physical status 1-2).

Exclusion criteria

• History of intravenous drug or opioid abuse;
• Previous history of chronic pain syndrome;
• Emergency cesarean section;
• Undergo general anaesthesia during cesarean delivery;
• Non-English speaking.

Trial design

595 participants in 4 patient groups

Control

Description:

Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Patients will be assigned to this group when they have a pain score of less than 3 (out of 10) at 6-10 post-delivery online/phone survey.

Treatment:

Procedure: Mechanical Temporal Summation assessment

Other: Preoperative pain assessment

Other: Questionnaires

Postoperative pain

Description:

Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Patients will be assigned to this group when they have a pain score of equal or more than 3 (out of 10) at 6-10 post-delivery online/phone survey.

Treatment:

Procedure: Mechanical Temporal Summation assessment

Other: Preoperative pain assessment

Other: Questionnaires

Control (non-Headspace)

Description:

Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Twenty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.

Treatment:

Procedure: Mechanical Temporal Summation assessment

Other: Preoperative pain assessment

Other: Questionnaires

Experimental (Headspace)

Description:

Questionnaires, Mechanical Temporal Summation assessment and preoperative pain assessment will be assigned to patient. Fifty five patients will be assigned to this group when they agree to participate in a sub-study on the use of a mindfulness exercise mobile app (Headspace). Patients will have a follow-up online/phone call survey at day 7-20 and 4-8 weeks after delivery.

Treatment:

Other: Headspace

Procedure: Mechanical Temporal Summation assessment

Other: Preoperative pain assessment

Other: Questionnaires