Post-operative Emesis and Pain Outcomes After Cesarean Delivery

Pain, Postoperative Clinical Trial

— EPOC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03645239
• Other study ID #: ANAESPRG18/02
• Status: Active, not recruiting
• Start date: May 24, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 595
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Section
• Nausea
• Nausea, Postoperative
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting
• Vomiting, Postoperative

Intervention

Procedure:
• Mechanical Temporal Summation assessment
A 180 gram von Frey filament is applied on the subject's forearm. Patient will then be asked to rate the pinprick pain score on a verbal rating scale, 0-100. Following this, 10 consecutive touches at random locations are applied with a 1 second interstimulus interval and within a 1 cm diameter circle. The patient will then be asked to rate the 10th pain score (0-100). The Mechanical Temporal Summation Score is obtained by the difference between the 11th pain score and the 1st pain score. If the score is greater than zero, the patient is implied to have presence of Mechanical Temporal Summation.

Other:
• Preoperative pain assessment
Patients will be asked to rate, using a 0-10mm visual analog scale (VAS), their surgical anxiety level ("On a scale of 0-100, with 0 being not anxious at all to 100 being extremely anxious, how anxious are you about your upcoming surgery?"), their anticipated pain (On a scale of 0-10, with 0 being no pain at all and 10 being pain as bad as you can imagine, how much pain do you anticipate experiencing after your upcoming surgery?"), and using a categorical scale, their anticipated pain medication need ("On a scale of 0 to 5, with 0 being none at all, 1 being much less than average, 2 being less than average, 3 being average, 4 being more than average, and 5 being much more than average, how much pain medication do you anticipate needing after your upcoming surgery?").
• Questionnaires
Questionnaires including Hospital Anxiety and Depression Scale (HADS), EQ-5D-3L, Edinburgh Postnatal Depression Scale (EPDS), Pain Catastrophizing Scale (PCS), Central Sensitisation Inventory (CSI), pain survey and breastfeeding questionnaire will be administered to the patient.
• Headspace
The mindfulness exercise mobile application, Headspace, will be downloaded into the patients' mobile devices. Patients will be asked to experience a mindfulness exercise for 10-30 minutes before delivery. HADS and pain score will be asked after the intervention.

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postsurgical pain scores in both groups: Numeric Rating Scale	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.	6 -10 weeks after delivery
Secondary	Pain vulnerability in both groups: Pain Catastrophizing Scale	Assessment will be done via Pain Catastrophizing Scale (PCS) questionnaire before surgery. Pain catastrophizing refers to the negative thought processes patients have when they are exposed to pain or painful experiences. The PCS is a 13-item scale, with each item rated on a 5-point scale: 0 (Not at all) to 4 (all the time). It is broken into three subscales being magnification (0-12), rumination (0-16), and helplessness (0-24). A higher value in each subscale indicates a higher tendency to that subscale (worse outcome).	7 weeks (Upon recruitment until 5-14 days after delivery)
Secondary	Mechanical Temporal Summation as measured by von Frey filament in both groups	Assessment will be done via Mechanical Temporal Summation assessment before surgery. A 180 gram von Frey filament is applied on the subject's forearm. Patient will then be asked to rate the pinprick pain score on a verbal rating scale, 0-100. Following this, 10 consecutive touches at random locations are applied with a 1 second interstimulus interval and within a 1 cm diameter circle. The patient will then be asked to rate the 10th pain score (0-100). The Mechanical Temporal Summation Score is obtained by the difference between the 11th pain score and the 1st pain score. If the score is greater than zero, the patient is implied to have presence of Mechanical Temporal Summation.	1 day (10 minutes)
Secondary	Edinburgh Postnatal Depression Scale (EPDS) before and after delivery	Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self reporting scale to evaluate the postnatal depression. Participants are asked to respond according to how they have felt in the past seven days. Each item is measured on a 4-point scale (0-3), with a total score in the range of 0 to 30. A higher total score indicates a greater degree of depressive symptoms. A score of 10 and above indicates clinically significant depressive symptoms.	6 -10 weeks after delivery