Post-operative Emesis and Pain Outcomes After Cesarean Delivery (EPOC)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain, Postoperative
- Sponsor
- KK Women's and Children's Hospital
- Enrollment
- 595
- Locations
- 1
- Primary Endpoint
- Postsurgical pain scores in both groups: Numeric Rating Scale
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed 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).
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Postsurgical pain scores in both groups: Numeric Rating Scale
Time Frame: 6 -10 weeks after delivery
Pain scores (Numeric Rating Scale 0-10) at 6-10 weeks follow-up evaluations. Zero being no pain, and 10 being the worst pain possible.
Secondary Outcomes
- Pain vulnerability in both groups: Pain Catastrophizing Scale(7 weeks (Upon recruitment until 5-14 days after delivery))
- Mechanical Temporal Summation as measured by von Frey filament in both groups(1 day (10 minutes))
- Edinburgh Postnatal Depression Scale (EPDS) before and after delivery(6 -10 weeks after delivery)