Pain After Cesarean Section - A Danish Multicenter Cohort Study.
Conditions: Pain, Cesarean Section, Recovery
Sponsor: Nordsjaellands Hospital

Pain after Cesarean section - A Danish 
multicenter cohort study. 
 
Document date: 11.8.23 
NCT ID: Not yet assigned 
 
Background  
Worldwide, more than 20 million children are born by cesarean sec6on each year (World Health 
Organiza6on 2021), making it one of the most commonly performed surgical procedures. Postopera6ve 
pain is typically moderate to severe in intensity (Sun and Pan 2019) and inadequate pain relief signiﬁcantly 
aﬀects the new mother's ability to mobilize and care for herself and her baby (Ciechanowicz et al. 2019) . 
Pain may also impact recovery and nega6vely aﬀect the early bonding between mother and child, as well as 
the establishment of breasLeeding (RooNhooN et al. 2021). Furthermore, there might be a correla6on 
between inadequately treated acute pain and the development of chronic pain aNer cesarean sec6on 
(Nikolajsen et al. 2004; Yimer and Woldie 2019). All these factors emphasize the necessity of eﬀec6ve pain 
management following cesarean sec6on. 
 
Only a few studies describe pain following cesarean sec6on in a Danish popula6on. Nikolajsen et al. 
(Nikolajsen et al. 2004) inves6gated the prevalence of chronic pain among 220 pa6ents interviewed one 
year aNer cesarean sec6on. A total of 46.8% recall to have experienced severe pain in the period shortly 
aNer the cesarean sec6on. In a Danish randomized placebo-controlled trial involving 72 pa6ents (Hansen et 
al. 2019) reported pain scores in pa6ents allocated to either a Transmuscular Quadratus Lumborum block 
(TQL) or placebo TQL following a cesarean sec6on. Both groups had access to intravenous morphine via 
pa6ent-controlled analgesia. The pa6ents scored their pain on a numeric ra6ng scale (NRS), ranging from 0 
to 10, where 0 is no pain and 10 is the most severe pain imaginable. ANer 6 hours, the TQL block group had 
an NRS (0-10) of 4 during movement, while the placebo group had an NRS of 5. At 12, 18 and 24 hours, both 
groups had similar NRS scores of 5, 4, and 3, respec6vely. The average 24-hour oral morphine equivalent 
consump6on was 65 mg for the TQL block group, compared to 94 mg for the group given placebo. 
 
That dosage is signiﬁcantly higher than recently described in a Danish uni-center quality study of 100 
pa6ents (Duch 2023). Among these pa6ents, 85 received the standard postopera6ve pain management for 
cesarean sec6on, which aligns with the pain treatment protocols employed in most hospitals across the 
country: A ﬁxed dose of paracetamol and NSAID, supplemented with oral morphine; nerve blocks or 
intrathecal morphine are not given rou6nely. The median 24-hour oral morphine equivalent dose given to 
the pa6ents by request to the nurses was 30 mg (IQR: 20-50). The rela6vely lower opioid dose 
may suggest an exis6ng underes6ma6on and subop6mal treatment of the pa6ents’ pain. At 6, 12, 18 and 
24 hours aNer the cesarean sec6on the reported average NRS (0-10) pain scores during movement were 7, 

6, 6, and 5 respec6vely, corresponding to moderate or severe pain, and further supports the possibility of 
underes6ma6on and undertreatment of post-cesarean pain.  
 
In a Danish mul6center survey conducted in 2020 to 2021 (Lindelof 2022), 861 cesarean sec6on pa6ents 
were asked 24-48 hours aNer surgery how much they agreed on having “experienced severe pain aNer the 
cesarean sec6on” In this assessment, 45% scored >= 8 (NRS 0-10). 
Overall, there is strong indications that currently a substantial number of women in Denmark experience 
severe pain in the first days after their cesarean section. To address this, we have established an obstetric-
anesthesiologic research cluster as part of the national perioperative research network, CEPRA (Nørskov et 
al. 2023) with an aim to optimize pain treatment for the approximately 12,700 Danish patients who 
undergo cesarean section every year. 
Objec&ve 
This study aims to map postoperative pain in Danish patients undergoing elective cesarean section. 
Specifically postoperative pain levels, impact on physical function, side effects from pain medication, and 
treatment approaches in the postoperative period. 
 
Furthermore, we aim to test the feasibility of repeated SMS-based ques6onnaires sent to the pa6ents in the 
postopera6ve period. Based on response rates and frequency of outcomes, data from this observa6onal 
study will also be used to inform a randomized controlled mul6center trial aiming to test bemer 
postopera6ve pain interven6ons for cesarean sec6on pa6ents.  
Method 
Study design 
Prospective Danish multicenter cohort study based on patient-reported outcomes (SMS-based 
questionnaires) and clinical data from electronic health records. 
 
Inclusion criteria  
Patients who undergo planned cesarean section under spinal anesthesia.  
Patients who speak and read Danish and can provide informed consent to participate. 
Patients who have a smartphone that can receive an SMS with a link to a questionnaire that can be 
accessed on an online website on the phone. 
 
Exclusion criteria  
Age < 18 years 
 
Number of par&cipants  
Minimum 400 patients, included from minimum 9 centers representing all 5 regions in Denmark. 
 

Outcomes  
Outcomes have been selected to align with the outcomes in a subsequent randomized controlled 
mul6center trial, where we will inves6gate whether the addi6on of intrathecal morphine provides bemer 
postopera6ve pain control. Therefore, opioid side eﬀects are given high priority in the outcome measures. 
The following abbrevia6ons are used in the sec6on outcome measures:  
Time intervals are specified as the time difference from the administration of the spinal anesthesia (t0), and 
outcomes are assessed either through patient questionnaires (P) or by reviewing medical records (J).  
 
Outcome measures 
 
Maternal outcomes 
Primary outcomes  
• 
Level of pain during the activity from lying to a seated position, after 24 hours. NRS 0-10 (P) 
 
• 
Morphine associated adverse events within 24 hours after CS, assessed as a binary 
outcome including nausea, vomiting, dizziness, itching, or urine-retention (P). Vomiting and urine-
retention, will be reported as yes/no. Nausea, dizziness and itching will be assessed as “none”, 
“little”, “moderate”, or “severe”, with patients reporting “moderate” or “severe” categorised as 
having a positive outcome.  
 
Secondary outcomes  
• 
Opioid consumption within the first 24 hours after caesarean section (oral morphine equivalents, 
mg) (J) 
• 
Insufficient spinal anesthesia related adverse events during the caesarean section, as binary 
composite outcome of the proportion of patients in need of conversion to general anesthesia, 
intraoperative opioids, sevoflurane, or nitrous oxide for intraoperative pain, or repeated neuraxial 
procedure (spinal or epidural placement following failed spinal). (J) 
• 
Level of pain during the activity from a lying to a seated position, after 6, 12, 18 hours. NRS 0-10 (P) 
• 
The ability to mobilize independently at 24 hours after surgery. Yes/No (P) 
• 
The ability to nurse infant independently at 24 hours after surgery. Yes/No (P) 
 
Exploratory outcomes 
• 
Level of pain at rest 6, 12, 18, 24, 48 hours, 7 days, and 30 days after surgery. NRS 0-10 (P) 
• 
Use of analgesic medication (Paracetamol (PCM), Non-Steroidal Anti-Inflammatory Drug (NSAID) 
and opioid) 6, 12, 18, 24, 48 hours, 7 days, and 30 days postoperatively. Yes/No. (P)  
• 
Level of pain during the activity from a lying to a seated position after 48 hours, 7 days and 30 days. 
NRS 0-10 (P) 
• 
Localization of pain: Abdomen, shoulder, head, back, other. 6, 12, 18, 24, 48 hours. (P) 

• 
Need for unplanned "rescue" ultrasound-guided truncal nerve block or epidural within 24 hours. 
Yes/No (J) 
• 
Maternal satisfaction with pain-treatment during the first 24 hours. Assessed after 24 hours. Likert 
scale of 0-4. Very dissatisfied, dissatisfied, neither satisfied nor dissatisfied, satisfied, very satisfied. 
(P) 
• 
Pain related self-efficacy and self-empowerment after surgery: The feeling of being in control 
during the first 24 hours, assessed after 24 hours, Likert scale (0-4). (P) 
• 
Composite outcome of rare maternal adverse events (J):    
o Clinically significant maternal respiratory depression within 24 hours defined as the need 
for airway intervention; oxygen therapy >3 L/min; administration of an opioid antagonist to 
counteract depressed respiration; or an intervention beyond verbal stimulus to rouse the 
patient from sedation reported the first 24h after surgery or 
o Maternal hospital readmission within 7 days, or  
o Maternal re-attendance or unplanned out-patient visit within 7 days. 
• 
The ability to handle own personal hygiene 24 hours after surgery. Yes/No (P) 
• 
Itching after 6, 12, 18, 48 hours, 4-point scale: None, mild, moderate, severe (P)  
• 
Dizziness after 6, 12, 18, 48 hours, 7 days, and 30 days, 4-point scale: None, mild, moderate, severe 
(P)  
• 
Nausea after 6, 12, 18, 48 hours, 7 days, and 30 days, 4-point scale: None, mild, moderate, severe 
(P) 
• 
The impact of pain on how often the patient has gotten out of bed in the last 6 hours. 6, 12, 18, 24, 
48 hours. 4-point scale: None, a little, moderate, a lot (P). 
• 
The impact of pain on how much the patient has breastfed or bottle-fed the infant in the last 6 
hours? 6, 12, 18, 24, 48 hours. 4-point scale: None, a little, moderate, a lot (P). 
• 
The impact of pain on the ability to resume regular daily activities. 7 and 30 days. 4-point scale: 
None, a little, moderate, a lot (P) 
• 
Obstetric Quality of Recovery score using Obs-QoR-10 (Pervez Sultan et al. 2020; P Sultan et al. 
2020)  
How much have you been bothered by this problem in the past 24 hours? 
1. Pain. 24 hours. None-worst imaginable 0-10. (P) 
2. Nausea or vomiting. 24 hours. None-worst imaginable 0-10. (P) 
3. Dizziness. 24 hours. None-worst imaginable 0-10. (P) 
4. Shivering. 24 hours. None-worst imaginable 0-10. (P) 
5. I have been comfortable. 24 hours. Not at all - all the time 0-10. (P) 
6. I am able to mobilize independently. 24 hours. Not at all - all the time 0-10. (P) 
7. I can hold my baby without assistance. 24 hours. Not at all - all the time 0-10. (P) 
8. I can feed/nurse my baby without assistance. 24 hours. Not at all - all the time 0-10. (P) 
9. I can look after my personal hygiene in the past 24 hours. 24 hours. Not at all - all the time 0-
10. (P) 
10. I feel in control in the past 24 hours. 24 hours. Not at all - all the time 0-10. (P) 

• 
Global Health Score (Euroqol 2023) 24 hours. Worst-best imaginable health state 0-100 (for 
validation of Obs-QoR-10) (P) 
• 
Response rates for questionnaires after 6,12,18,24,48 hours plus 7 and 30 days after the cesarean 
section. 
• 
Response time for questionnaires after 6,12,18,24,48 hours plus 7 and 30 days after the cesarean 
section. 
 
 
Neonatal outcomes  
Primary outcome 
• 
Need for neonatal admission within 24 hours (yes/no). (J) 
Secondary outcomes 
• 
Infants in need of respiratory support within 48 hours (continuous positive airway pressure 
treatment, positive pressure ventilation, HNF (nasal high flow), intubation or oxygen therapy). 
Yes/No and time (J) 
• 
Proportion with established breastfeeding at 30 days following delivery, if intended. (P) 
Exploratory outcomes 
• 
Apgar score at 5 minutes. (J) 
• 
Apgar score at 10 minutes. (J)  
• 
Proportion of infants with Apgar <7 at 5 minutes. (J)  
• 
Readmission within 24 hours after discharge. Yes/No. 
• 
Readmission within 7 days after discharge. Yes/No. 
 
 
Development and valida&on of ques&ons:  
The questions were developed with inspiration from international consensus regarding obstetric recovery, 
including the incorporation of the Obs-QoR-10 score (Pervez Sultan et al. 2020; P Sultan et al. 2020) and the 
use of NRS scores for pain assessment (Eisenach et al. 2008; Hansen et al. 2019). Additionally, we have 
drawn on experience and knowledge gained from the pilot study by Duch et al. (Duch 2023) preceding this 
national study, which involved the participation of 100 patients. Patients, maternity staff, anesthetists, and 
obstetricians was consulted to determine the key areas of focus during the first postoperative days after a 
cesarean section. The questions were developed and validated by using standardized methods for 
designing and conducting surveys (Eysenbach 2004; Burns et al. 2008). Subsequently, the questionnaires 
were created in the database: Research Electronic Datacapture (REDCap) (“RedCap” n.d.)  
 
Data collec&on  
All data is entered directly into the closed and secure system, REDCap (Harris et al. 2009), which is approved 
by all the regions in Denmark. Ques6onnaires are sent to the pa6ent aNer 6, 12, 18, 24, and 48 hours, as 
well as 7 and 30 days aNer spinal anesthesia for cesarean sec6on (t0). The ques6onnaires are delivered to 

the pa6ent's smartphone as an SMS with a link to a ques6onnaire in REDCap. Data from journal entries are 
also entered into REDCap. At all hospitals, there is a data manager who has access to REDCap and can 
retrieve data for the pa6ents included in the project. The primary inves6gator holds the overall 
responsibility. 
Ethics and approvals 
This study complies with the Helsinki declara6on. The protocol will be made available on the website 
clinicaltrials.gov prior to inclusion of pa6ents. Par6cipa6on is completely voluntary, and consent can be 
withdrawn at all 6mes. 
 
Data Protec6on Authority  
Approval for data collection, handling and storage has been granted by the data protection authority for 
the Capital Region (Region Hovedstaden) with case number P-2023-90. This includes approved data 
agreements between the Danish Regions, with a designated data manager from each participating hospital. 
(See Appendix 1) 
 
Research Ethics Commi;ee  
The Research Ethics Committee (VEK) and the regional research ethics committee for the Capital Region of 
Denmark (Region Hovedstaden) have been presented with the project description and protocol and have 
waivered the need approval due to Danish legislation. Case number F-23004686. (See Appendix 1) 
Informed consent  
Verbal informed consent is obtained during the inclusion process with each patient. The patient must 
consent to receive questionnaires on the mobile phone and to the data manager accessing the medical 
records related to the cesarean section for the patient and the baby. The patient is informed that 
participation is voluntary and that their data will be securely stored. Written description of the consent is 
electronically sent to the patient, including a description of how to withdraw consent. This is approved by 
the data protection authority for the Capital Region of Denmark (Region Hovedstaden) with case number P-
2023-90 
 
Data Processing and sta6s6cs 
All data will be handled in the secure REDCap database. Descriptive statistics will be used to analyze data. 
Continuous data will be summarized as median (interquartile range) or mean if the data is normally 
distributed. We plan to do a subgroup analysis on the groups where intrathecal morphine or TQL block has 
been administered. And categorical data as frequency (percentage). We will try to minimize missing data as 
much as possible, by sending questionnaires directly to the participants mobile phones. Number of missing 
data will be accounted for when describing data. Sample size is determined by convenience. The study is 
designed to be as large as possible, as all hospitals in Denmark, handling elective cesarean sections, will be 
invited to participate. Larger sites (>300 elective CS per year) commits to include 50 patients, medium scale 
sites (200-300 elective CS per year) commit to include 40 patients, and smaller sites (<200 elective CS per 
year) commits to include 30 patients. 
 

Collabora6on Agreement  
A collaboration agreement has been established between project leaders and site coordinators, outlining 
mutual obligations and rules for data usage. 
 
Inclusion Period  
01.09.2023-31.12.2024, 1-6 months depending on the rate of inclusion at different sites. 
 
Par&cipa&ng Departments 
Maternity units from all 5 Danish regions. The following hospitals have agreed to participate: 
Capital Region of Denmark (Region Hovedstaden): Hilleroed, Herlev, Hvidovre, Rigshospitalet 
Region Zealand (Region Sjaelland): Roskilde  
Region of Southern Denmark (Region Syd): Kolding, Odense  
Central Denmark Region (Region Midt): Aarhus  
North Denmark Region (Region Nord): Aalborg  
 
The study is open for all Danish hospitals, where elec6ve cesarean sec6ons are performed. If any addi6onal 
hospitals should wish to par6cipate in the study within the speciﬁed 6me period, they will be included. 
 
 
 

Data to be collected from the pa&ent’s medical record 
Patient characteristics 
• 
Pre-pregnancy BMI  
• 
Parity  
• 
Indication for cesarean section: Maternal request/Previous cesarean section as the only 
indication/Breech presentation/Maternal indication/Obstetric indication/Fetal indication/Other 
indication. 
• 
Previous number of cesarean sections: 0, 1, 2, 3, or ≥4  
• 
Previous abdominal surgeries: Yes/No. If yes: Laparoscopic or laparotomy  
• 
Chronic pain patient (receiving regular opioid or other pain treatment besides NSAIDs and PCM) 
within 0-2 months prior to cesarean section: Yes/No  
• 
Inflammatory bowel disease (Crohn's disease or ulcerative colitis): Yes/No 
• 
Pregnancy-related illness? No/Gestational hypertensive disorder (Preeclampsia including HELLP, 
Gestational hypertension)/Gestational diabetes, Other.  
 
Anesthesia information 
• 
Spinal anesthesia: Bupivacaine, sufentanil, fentanyl, morphine. Mg and ml.   
• 
Was the patient given an epidural-spinal? Yes/No  
• 
Was general anesthesia administered as the initial preference for the patient? Yes/No 
• 
Was the spinal anesthesia converted to epidural? Yes/No  
• 
Was the spinal anesthesia converted to general anesthesia? Yes/No  
• 
Was the spinal repeated following a failed spinal? Yes/No 
• 
Was it necessary to supplement the spinal anesthesia with opioids, nitrous oxide, or similar due to 
breakthrough pain during the operation? Yes/No  
• 
Did the patient have an epidural when going to the maternity ward after the recovery period? 
Yes/No. If yes: When was the epidural discontinued? Date and Time. 
 
Operation information  
• 
Operation time (minutes)  
• 
Intraoperative bleeding. ml.  
• 
Has the uterus been exteriorized during the operation? Yes/No/The information was not found in 
the medical record.  
• 
Postoperative bleeding within the first 48 hours requiring blood transfusion. Yes/No  
• 
Reoperation within the first 30 days: Yes/No. If yes: Abdominal bleeding/Vaginal 
bleeding/Suspected retained tissue or endometritis/Infection at the incision site/other reason 
 
Pain management  
• 
Nerve blockade within the first 24 hours after the cesarean section: Yes/No; Time; Block type, dose, 
medication, reason.  
• 
Placement of an epidural within the first 24 hours after the cesarean section: Yes/No; Time, reason  

• 
Opioid consumption within 0-24 hours, mg oral morphine equivalents  
• 
Opioid consumption within 25-48 hours, mg oral morphine equivalents  
• 
Administration of dexamethasone within the first 24 hours after cesarean section: Yes/No. Dose.  
• 
Administration of antihistamine as itch relief within the first 24 hours: Yes/No 
• 
Administration of naloxone as itch relief within the first 24 hours: Yes/No 
 
Maternal hospitalization 
• 
Duration of total hospital lengths of stay after cesarean section (number of days)  
• 
Maternal readmission or unplanned outpatient consultation within 7 days. Yes/No  
• 
Occurrence of clinically significant maternal respiratory depression within 24 hours, defined as the 
need for airway intervention; oxygen therapy >3 L/min; administration of an opioid antagonist to 
counteract depressed respiration; or an intervention beyond verbal stimulus to rouse the patient 
from sedation. Yes/No 
• 
Ogilvie's syndrome/ileus, that requires surgery or neostigmine within the first 7 days after cesarean 
section: Yes/No 
 
Infant 
• 
Apgar score at 5 minutes  
• 
Apgar score at 10 minutes  
• 
Neonatal hospitalization within 24 hours: Yes/No 
• 
Neonatal readmission within 24 hours: Yes/No 
• 
Neonatal readmission within 7 days: Yes/No 
• 
Neonatal need for respiratory support within 48 hours (CPAP, PPV, HNF, intubation, or oxygen 
supplementation): Yes/No; Time of initiation; Duration (hours < 24 or number of days > 1) 
 
 
 

Appendix 1a-f 
1a Project approval from the research lawyer at The Capital Region (Region Hovedstaden) Center for Data 
Notifications. Approval number P-2023-90.  
1b Ethical approval assessment, journal number F-23004686. 
1c-1f Data agreements for research projects between the regions.  
Appendix 2: Collaboration agreement. 
Appendix 3: Data extraction sheet for journal review. 
Appendix 4: Overview of the questions that are set up as questionnaires in REDCap and sent to the patient 
via a link in SMS. 
 
 
 

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