Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery (MoFe)

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Obstetric Pain
• Intervention / Treatment: Procedure: Fentanyl 1; Procedure: Fentanyl2; Procedure: Fentanyl 3

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 63
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roberto Dossi; Phone Number: 0918119341; Email: roberto.dossi@eoc.ch
• Study Contact Backup: Name: Alessandra Lauretta; Phone Number: 0918118182; Email: alessandra.lauretta@eoc.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Spinal anesthesia with no fentanyl	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
Experimental: Experimental 1; Spinal anesthesia with 10 mcg of fentanyl	Procedure: 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
Experimental: Experimental 2; Spinal anesthesia with 20 mcg of fentanyl	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Controlled Analgesia morphine consumption	Patient Controlled Analgesia morphine consumption in the first 24 postoperative hours	Day 1 after cesarean section
obstetric quality of recovery score	obstetric quality of recovery score (ObsQoR-11)	Day 1 after cesarean section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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)
intraoperative hypotension	intraoperative hypotension	during the cesarean section
intraoperative opioids	intraoperative opioids in morphine equivalents	during the cesarean section
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
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
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)

Collaborators and Investigators

• Sponsor: Ente Ospedaliero Cantonale, Bellinzona

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cesarean section; Fentanyl; Functional Recovery
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; 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; Fentanyl
• Other Study ID Numbers: 2024-00019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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