Pain, PostoperativeEPOCNCT03645239
Post-operative Emesis and Pain Outcomes After Cesarean Delivery
An observational study of Pain, Postoperative and Cesarean Section, run by KK Women's and Children's Hospital at 1 site in Singapore.
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)… Read more about this study
- Who is it for?
- Ages 21 to 50 years, women only
- Conditions the study is for
- Pain, Postoperative, Cesarean Section, Nausea, Postoperative
- What is being tested?
- Mechanical Temporal Summation assessment, Preoperative pain assessment and Questionnaires
- Type of treatment
- Surgery or procedure
- How many people
- 595 participants
- Where
- 1 siteSingapore
- Study dates
- 24 May 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- Women only
- Adult
Study population: Pregnant females undergoing cesarean delivery.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Post-operative Emesis and Pain Outcomes After Cesarean Delivery (EPOC)
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.
Read the 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).
- Being tested
- Mechanical Temporal Summation assessment, Preoperative pain assessment, Questionnaires, Headspace
- Keywords
- Postoperative pain, Cesarean delivery, Postoperative nausea and vomiting
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical Temporal Summation assessmentProcedure or surgery
Also called MTS
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.
Preoperative pain assessmentOther
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?").
QuestionnairesOther
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.
HeadspaceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | 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. Receives: Procedure: Mechanical Temporal Summation assessment; Other: Preoperative pain assessment; Other: Questionnaires | |
| Postoperative pain | 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. Receives: Procedure: Mechanical Temporal Summation assessment; Other: Preoperative pain assessment; Other: Questionnaires | |
| Control (non-Headspace) | 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. Receives: Procedure: Mechanical Temporal Summation assessment; Other: Preoperative pain assessment; Other: Questionnaires | |
| Experimental (Headspace) | 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. Receives: Procedure: Mechanical Temporal Summation assessment; Other: Preoperative pain assessment; Other: Questionnaires; Other: Headspace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 -10 weeks after delivery
Secondary outcomes (3)
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).
Measured: 7 weeks (Upon recruitment until 5-14 days after delivery)
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.
Measured: 1 day (10 minutes)
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.
Measured: 6 -10 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start24 May 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 595 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Sng Ban Leong, KK Women's and Children's Hospital
- Investigators
- Farida Ithnin, MB BCh BAO, Principal investigator, KK Women's and Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645239
- Sponsor's protocol ID
- ANAESPRG18/02
- Acronym
- EPOC
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2018
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tan HS, Tan CW, Sultana R, Lim CH, Chan JJI, Habib AS, Sng BL. Factors associated with postoperative nausea or vomiting in parturients undergoing caesarean delivery under spinal anaesthesia with intrathecal morphine: A prospective cohort study. Eur J Anaesthesiol. 2022 Jan 1;39(1):75-77. doi: 10.1097/EJA.0000000000001427. No abstract available.
PubMed 34857684
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Emesis and Pain Outcomes After Cesarean Delivery (EPOC)
- ClinicalTrials.gov ID
- NCT03645239
- Acronym / sponsor ID
- EPOC / ANAESPRG18/02
- Keywords
- Postoperative pain, Cesarean delivery, Postoperative nausea and vomiting
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 595 participants (estimated)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- 24 May 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | – | Procedure: Mechanical Temporal Summation assessment, Other: Preoperative pain assessment, Other: QuestionnairesQuestionnaires, 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. |
| Postoperative pain | – | Procedure: Mechanical Temporal Summation assessment, Other: Preoperative pain assessment, Other: QuestionnairesQuestionnaires, 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. |
| Control (non-Headspace) | – | Procedure: Mechanical Temporal Summation assessment, Other: Preoperative pain assessment, Other: QuestionnairesQuestionnaires, 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. |
| Experimental (Headspace) | – | Procedure: Mechanical Temporal Summation assessment, Other: Preoperative pain assessment, Other: Questionnaires, Other: HeadspaceQuestionnaires, 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant females undergoing cesarean delivery.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical Temporal Summation assessmentAlso: MTSA 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. | Procedure or surgery | Control, Control (non-Headspace), Experimental (Headspace), Postoperative pain |
| Preoperative pain assessmentPatients 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?"). | Other | Control, Control (non-Headspace), Experimental (Headspace), Postoperative pain |
| QuestionnairesQuestionnaires 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. | Other | Control, Control (non-Headspace), Experimental (Headspace), Postoperative pain |
| HeadspaceThe 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. | Other | Experimental (Headspace) |
Primary outcome
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.
3 secondary outcomes
Pain vulnerability in both groups: Pain Catastrophizing Scale
Time frame: 7 weeks (Upon recruitment until 5-14 days after delivery)
Mechanical Temporal Summation as measured by von Frey filament in both groups
Time frame: 1 day (10 minutes)
Edinburgh Postnatal Depression Scale (EPDS) before and after delivery
Time frame: 6 -10 weeks after delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Derived from this study: PubMed 34857684Tan HS, Tan CW, Sultana R, Lim CH, Chan JJI, Habib AS, Sng BL. Factors associated with postoperative nausea or vomiting in parturients undergoing caesarean delivery under spinal anaesthesia with intrathecal morphine: A prospective cohort study. Eur J Anaesthesiol. 2022 Jan 1;39(1):75-77. doi: 10.1097/EJA.0000000000001427. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Farida Ithnin, MB BCh BAO principal investigator
KK Women's and Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Cesarean Section, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postsurgical pain scores in both groups: Numeric Rating Scale (time frame: 6 -10 weeks after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.