Clinical trial NCT03645239: Post-operative Emesis and Pain Outcomes After Cesarean Delivery
Official title: Post-operative Emesis and Pain Outcomes After Cesarean Delivery (EPOC)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pain, Postoperative
Cesarean Section
Nausea, Postoperative
Vomiting, Postoperative
Keywords: Postoperative pain
Cesarean delivery
Postoperative nausea and vomiting
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2018-08-24
Enrollment: 595
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females undergoing cesarean delivery.

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).

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.

Primary outcomes:
measure: Postsurgical pain scores in both groups: Numeric Rating Scale
timeFrame: 6 -10 weeks after delivery
Secondary outcomes:
measure: Pain vulnerability in both groups: Pain Catastrophizing Scale
timeFrame: 7 weeks (Upon recruitment until 5-14 days after delivery)
measure: Mechanical Temporal Summation as measured by von Frey filament in both groups
timeFrame: 1 day (10 minutes)
measure: Edinburgh Postnatal Depression Scale (EPDS) before and after delivery
timeFrame: 6 -10 weeks after delivery
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Farida Ithnin, MB BCh BAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.