Postoperative Pain After Caesarian Section

Impact of Guideline Recommendations for Post-caesarean Analgesia on Pain, Nausea and Pruritus

To examine if perioperative pain/nausea/pruritus is altered when current standard analgesia for caesarian section (CS) is replaced with new guideline recommended analgesia.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Consumption; Pruritus; Nausea and Vomiting Following Administration of Anaesthetic Agent
• Intervention / Treatment: Drug: Bupivacaine-fentanyl elective group; Drug: Bupivacaine-fentanyl-morphine elective group; Drug: Bupivacaine-fentanyl emergency group

Detailed Description

Control group (current analgesia, elective CS) is compared to current analgesia for emergency CS, and guideline recommended analgesia.

Current analgesia for CS:

Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 10-15 ug. Postoperative: Paracetamol 1g x 4, ibuprofen 400 mg x 4 po, oxycodone 10 mg (<70 kg) or 20 mg (>70 kg) x 2 po, additional oxycodone 2,5 mg iv/5 mg po when needed.

Guideline recommended analgesia for CS:

Spinal hyperbaric bupivacaine 5 mg/ml, 9-11 mg. Spinal fentanyl 12,5 ug. Spinal morphine 0,05 mg. After delivery of baby: Dexamethasone 8 mg iv, paracetamol 1g iv, parecoxib 40 mg iv.

Postoperative: Paracetamol 1g x 4, ibuprofen 600 mg x 4 po, oxycodone 2,5 mg iv/5 mg po when needed.

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 4

Contacts and Locations

Study Locations

• Norway
  • Rogaland
    • Stavanger, Rogaland, Norway, 4068
      • Stavanger University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Healthy parturient, term pregnancy, undergoing caesarian section

Exclusion Criteria:

• Patient refusal
• Maternal heart or lung disease (not including mild asthma)
• Known or suspected obstructive sleep apnoea syndrome
• Pre-eclampsia
• Body mass index > 40
• Indulin-dependent diabetes mellitus
• Contraindications to ibuprofen, dexamethasone or morphine
• Chronic pain
• Neurological disease
• Drug abuse
• Age < 18 years
• American Society of Anesthesiologists (ASA) 3
• Patients receiving other forms of anaesthesia (epidural or general)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Elective CS patients receiving current analgesia.	Drug: Bupivacaine-fentanyl elective group; Current analgesia in elective caesarian section.
Experimental: Intervention group; Elective CS patients receiving guideline recommended analgesia.	Drug: Bupivacaine-fentanyl-morphine elective group; Guideline recommended analgesia in elective caesarian section.
Experimental: Emergency group; Emergency CS receiving current analgesia.	Drug: Bupivacaine-fentanyl emergency group; Current analgesia in emergency caesarian section.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain at postoperative care unit arrival	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	Immediately upon arrival at postoperative care unit
Postoperative pain at 30 minutes	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At postoperative care unit 30 minutes after arrival
Postoperative pain at 60 minutes	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At postoperative care unit 60 minutes after arrival
Postoperative pain at 90 minutes	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At postoperative care unit 90 minutes after arrival
Postoperative pain at 120 minutes	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At postoperative care unit 120 minutes after arrival
Postoperative pain at maternity ward arrival	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	Immediately upon arrival at maternity ward
Postoperative pain at maternity ward 4 hours after arrival	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At maternity ward 4 hours after arrival
Postoperative pain at maternity ward 8 hours after arrival	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At maternity ward 8 hours after arrival
Postoperative pain at maternity ward 12 hours after arrival	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At maternity ward 12 hours after arrival
Postoperative pain at maternity ward 16 hours after arrival	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At maternity ward 16 hours after arrival
Postoperative pain at maternity ward 20 hours after arrival	Postoperative pain during rest and movement measured by numeric rating scale (NRS).	At maternity ward 20 hours after arrival

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative nausea and vomiting at postoperative care unit	Present (yes/no) during stay at the postoperative care unit	During stay at postoperative care unit, estimated average 2 hours
Postoperative nausea and vomiting at maternity ward	Present (yes/no) during stay at the maternity ward	During stay at maternity ward, estimated average 22 hours
Postoperative pruritus at postoperative care unit	Present (yes/no) during stay at the postoperative care unit	During stay at postoperative care unit, estimated average 2 hours
Postoperative pruritus at maternity ward	Present (yes/no) during stay at the maternity ward	During stay at maternity ward, estimated average 22 hours
Postoperative additional oxycodone consumption at postoperative care unit	Number of mg of oxycodone administered as additional analgetics	During stay at postoperative care unit, estimated average 2 hours
Postoperative additional oxycodone consumption at maternity ward	Number of mg of oxycodone administered as additional analgetics	During stay at maternity ward, estimated average 22 hours

Collaborators and Investigators

• Sponsor: Conrad Arnfinn Bjørshol
• Investigators: Study Chair: Conrad A Bjørshol, PhD, MD, Helse Stavanger HF

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2020
• Primary Completion (Actual): November 5, 2021
• Study Completion (Actual): November 5, 2021

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Skin Manifestations; Pain, Postoperative; Nausea; Vomiting; Pruritus; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine; Morphine
• Other Study ID Numbers: 1399-2435

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No