Fentanyl Versus Morphine in Spinal Anesthesia for Caesarian Section - Study on Analgesia, Side Effects and Patient 's Satisfaction

NCT05533229 | Completed

• 1 other identifier: 07FvM_Medical Study
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Intrathecal morphine and fentanyl are used for anesthesia and perioperative pain management in caesarian section. Despite the fact that spinal Fentanyl is better tolerated, might not be enough for postoperative pain control. Morphine offers an improved analgesia but might be not tolerated due to a higher incidence of side effects, especially nausea and vomiting. This is a prospective, randomized, double-blind, parallel study including 80 parturients scheduled for elective CS. Spinal anesthesia is consisting in bupivacaine (7.5 - 10 mg in relation to height) and either fentanyl 25 mcg (F group) either morphine 100 mcg (m group). It will be assessed intraoperative and postoperative pain scores, the incidence of sides effects, patient's satisfaction and systemic opioids consumption.

Conditions

Anesthesia

Keywords

spinal anesthesia, pain scores, spinal opioids side effects, patient's satisfaction

Outcome Measures

Primary Outcomes (2)

• to assess the perioperative analgesia using Numeric Pain Scale

  assessing pain scores (at surgical incision, end of surgery, at 4 h, 6 h, 12 h, 24 h, 48 h, 72 h - postoperative the pain scores were assessed at rest and on mobilization); AUE72h (sum pain intensity differences area over 72 hours) and SPID72h (time-weighted sum pain intensity differences over 72 hours); the pain scores according to the Numeric Pain Scale it will be rated between 0 and 10, meaning 0 - no pain and 10 - the worst pain imaginable

  6 months

• assessing the degree of patient's of satisfaction

  assessing the degree of satisfaction on a five point scale with the highest rate as being "completely satisfied", followed by "satisfied", "so so", "unsatisfied" and "completely usatisfied"

  6 months

Secondary Outcomes (2)

• to assess the incidence of and degree of pruritus as a side effect related to intrathecal opioids

  6 months

• to assess the incidence of other side effects related to intrathecal opioids

  6 months

Study Arms (1)

Pregnant patients scheduled for C section

Spinal anesthesia

Drug: Fentanyl; Drug: Morphine

Interventions

Fentanyl DRUG

The trial aims to study the quality of anesthesia and perioperative analgesia and patient's satisfaction provided by fentanyl and bupivacaine versus morphine and bupivacaine.

Also known as: plus Bupivacaine

Pregnant patients scheduled for C section

Morphine DRUG

The trial aims to study the quality of anesthesia, perioperative analgesia and patient's satisfaction provided by fentanyl and bupivacaine versus morphine and bupivacaine.

Also known as: plus Bupivacaine

Pregnant patients scheduled for C section

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: study's population is the pregnant woman
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The study population will be selected from the pregnant patients of Oradea Pelican Clinic Hospital.

You may qualify if:

• ASA I-II patients
• no medical past history
• not known allergies to the used medication
• no history of chronic pain ar regular use of analgesics
• no past history of anxiety or depression
• body weight ≥ 50 kg
• elective C section indication
• single fetus

You may not qualify if:

• conversion from a natural delivery with/without an epidural anesthesia started
• pregnant women with psychiatric disorder;
• history of drug addiction; diagnosis of acute or chronic fetal distress; contraindication of spinal anesthesia;
• patient refusal;
• preeclamptic patients, patients who developed allergic reaction after enrolling in the study;
• refusal of the pain killers or other protocol medication prescribed;
• the necessity of surgical reintervention in the next 72 h after C-section;
• previous administration of opioids and/or other central nervous system depressants.

Sponsors & Collaborators

• Dr. Mihai Octavian Botea: lead
• Oradea Pelican Clinic Hospital: collaborator

Study Sites (1)

University of Oradea, Pelican Clinic Hospital

Oradea, Bihor County, 410505, Romania

Location

Related Publications (9)

• Fonseca NM, Guimaraes GMN, Pontes JPJ, Azi LMTA, de Avila Oliveira R. Safety and effectiveness of adding fentanyl or sufentanil to spinal anesthesia: systematic review and meta-analysis of randomized controlled trials. Braz J Anesthesiol. 2023 Mar-Apr;73(2):198-216. doi: 10.1016/j.bjane.2021.10.010. Epub 2021 Dec 24.

  PMID: 34954261 RESULT

• Karaman S, Gunusen I, Uyar M, Biricik E, Firat V. The effects of morphine and fentanyl alone or in combination added to intrathecal bupivacaine in spinal anesthesia for cesarean section. Agri. 2011 Apr;23(2):57-63.

  PMID: 21644105 RESULT

• Weigl W, Bierylo A, Wielgus M, Krzemien-Wiczynska S, Kolacz M, Dabrowski MJ. Perioperative analgesia after intrathecal fentanyl and morphine or morphine alone for cesarean section: A randomized controlled study. Medicine (Baltimore). 2017 Dec;96(48):e8892. doi: 10.1097/MD.0000000000008892.

  PMID: 29310376 RESULT

• Seki H, Shiga T, Mihara T, Hoshijima H, Hosokawa Y, Hyuga S, Fujita T, Koshika K, Okada R, Kurose H, Ideno S, Ouchi T. Effects of intrathecal opioids on cesarean section: a systematic review and Bayesian network meta-analysis of randomized controlled trials. J Anesth. 2021 Dec;35(6):911-927. doi: 10.1007/s00540-021-02980-2. Epub 2021 Aug 2.

  PMID: 34338864 RESULT

• Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.

  PMID: 19565683 RESULT

• Overall JE, Shobaki G, Shivakumar C, Steele J. Adjusting sample size for anticipated dropouts in clinical trials. Psychopharmacol Bull. 1998;34(1):25-33.

  PMID: 9564195 RESULT

• Stewart WC, Jackson AL, Jenkins JN. Dropout rates for intent-to-treat and per protocol analyses. Am J Ophthalmol. 2004 Apr;137(4):639-45. doi: 10.1016/j.ajo.2003.11.028.

  PMID: 15059702 RESULT

• Girgin NK, Gurbet A, Turker G, Aksu H, Gulhan N. Intrathecal morphine in anesthesia for cesarean delivery: dose-response relationship for combinations of low-dose intrathecal morphine and spinal bupivacaine. J Clin Anesth. 2008 May;20(3):180-5. doi: 10.1016/j.jclinane.2007.07.010.

  PMID: 18502360 RESULT

• Mallick-Searle T, Fillman M. The pathophysiology, incidence, impact, and treatment of opioid-induced nausea and vomiting. J Am Assoc Nurse Pract. 2017 Nov;29(11):704-710. doi: 10.1002/2327-6924.12532.

  PMID: 29131554 RESULT

MeSH Terms

Interventions

Fentanyl; Bupivacaine; Morphine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Erika Bimbo-Szuhai, MD PhD

  Head of Anesthesia Department at Oradea Pelican Clinic Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Assistant professor

Study Record Dates

• First Submitted: July 10, 2022
• First Posted: September 8, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2023
• Study Completion: August 10, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

RO (1)