Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery

Obstetric Pain Clinical Trial

— MoFe  

Official title:

Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery Adding Different Doses of Intrathecal Fentanyl to Spinal Anesthesia With Bupivacaine and Intrathecal Morphine. A Single Center, Randomized, Multiple Blinded, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06355271
• Other study ID #: 2024-00019
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: September 1, 2025

Study information

• Verified date: March 2024
• Source: Ente Ospedaliero Cantonale, Bellinzona
• Contact: Roberto Dossi
• Phone: 0918119341
• Email: roberto.dossi[@]eoc.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Based on randomization, patients will receive a mixture for spinal anesthesia and will be followed in the following hours for the various outcomes and for functional recovery

Description:

In the study intervention group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 %, morphine sulfate 100 mcg and an added randomized dose of 10 or 20 mcg IT fentanyl. The spinal anesthetic will be administered with a 27 gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. The fentanyl doses will be prepared by an anesthesiologist who will not be involved in the study or the patient's treatment. For 24 hours following surgery, each patient would receive intravenous patient-controlled morphine analgesia. In the control group every patient will receive a spinal anesthesia composed by hyperbaric bupivacaine 12 mg 0,5 % and morphine sulfate 100 mcg. The spinal anesthetic will be administered with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position. Sterile saline will be used to dilute the mixture to a final volume of 3.1 mL. The allocated treatment will be kept a secret from the patient, the anesthesiologist managing the patient, and the entire study team. For 24 hours following surgery, each patient would receive intravenous patient- controlled morphine analgesia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 63
• Est. completion date: September 1, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients over 18 year of age

• height over 160 cm

• American Society Anesthesiologists physical status I and II

• term singleton parturients

• scheduled for elective cesarean delivery during spinal anesthesia at Ospedale Regionale Bellinzona Valli

Exclusion Criteria:

• patients with inability to consent

• patient refusal

• contraindication to spinal anesthesia (eg, hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis)

• emergency cesarean delivery

• preeclampsia/eclampsia

• allergy to drugs used in the protocol

Related Conditions & MeSH terms

• Labor Pain
• Obstetric Pain

Intervention

Procedure:
• Fentanyl 1
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and no fentanyl
• Fentanyl2
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 10 mcg of of fentanyl
• Fentanyl 3
Spinal anesthesia with a 27- gauge Whitacre needle at the L2-3 or L3-4 intervertebral space with the patient in sitting position with hyperbaric bupivacaine 0,5 %12 mg, 100 mcg of morphine, and 20 mcg of fentanyl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Cantonale, Bellinzona

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Controlled Analgesia morphine consumption	Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours	Day 1 after cesarean section
Primary	obstetric quality of recovery score	obstetric quality of recovery score (ObsQoR-11)	Day 1 after cesarean section
Secondary	Visual Analogue Scale	pain scores after surgery (Visual Analogue Scale -VAS- where 0 is the minimum value and 10 is the maximum value. The higher is the score the worse is pain control) at 4, 12 e 24 h.	Day 1 after cesarean section
Secondary	pruritus	Intraoperative and postoperative pruritus (rating 0-10 The higher is the score the worse is pruritus)	Day 1 after cesarean section (and day 0 for intraoperative pruritus)
Secondary	nausea and vomiting; considering it as a dichotomous variable (yes or no), without evaluating its entity	intraoperative and postoperative nausea and vomiting	Day 1 after cesarean section (and day 0 for intraoperative nausea and vomiting)
Secondary	intraoperative hypotension	intraoperative hypotension	during the cesarean section
Secondary	intraoperative opioids	intraoperative opioids in morphine equivalents	during the cesarean section
Secondary	satisfaction rate	satisfaction rate (0-100, where 0 is the minimum value and 100 is the maximum value. The higher is the score the better is the satisfaction rate)	Day 1 after cesarean section
Secondary	intraoperative pain	intraoperative pain Visual Analogue Scale (Visual Analogue Scale -VAS- where 0 is the minimum value and 10 is the maximum value. The higher is the score the worse is pain control)	during the surgery