Post-operative Emesis and Pain Outcomes After Cesarean Delivery

NCT03645239 | Active Not Recruiting

• 1 other identifier: ANAESPRG18/02
• Study Type: observational
• Target: 595
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Postoperative pain; Cesarean delivery; Postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (4)

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.

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.

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.

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.

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

Interventions

Mechanical Temporal Summation assessment PROCEDURE

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.

Also known as: MTS

Control; Control (non-Headspace); Experimental (Headspace); Postoperative pain

Preoperative pain assessment OTHER

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?").

Control; Control (non-Headspace); Experimental (Headspace); Postoperative pain

Questionnaires OTHER

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.

Control; Control (non-Headspace); Experimental (Headspace); Postoperative pain

Headspace OTHER

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.

Experimental (Headspace)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Gender Eligibility Details: Only female undergoing cesarean delivery in the institution will be recruited.
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant females undergoing cesarean delivery.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (1)

• 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.

  PMID: 34857684 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Farida Ithnin, MB BCh BAO

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2018
• First Posted: August 24, 2018
• Study Start: May 24, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)