Clinical trial · Interventional
Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization
Hemodynamic Stability of Bupivacaine With and Without Adrenaline for Paracervical Block for Cervical Conization During General Anesthesia: A Randomized Controlled Double Blinded Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cervical conization is done for pre-cancer disease. The procedure is performed with local anesthesia and general anesthesia. Local anesthesia is given by paracervical block, and several different local anesthetics is being used including bupivacaine with and without adrenaline. Adrenaline might reduce local bleeding and reduce toxicity of bupivacaine by reducing absorption, but might affect cardiovascular function. This study will examine this effect.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adrenaline | Drug | — | UNRESOLVED |
| Bupivacaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Bupivacaine-adrenaline
- description
- Paracervical block. Bupivacaine 2,5 mg/ml Adrenaline 5 microg/ml; 20 ml
- interventionNames
- Drug: Bupivacaine
- Drug: Adrenaline
- type
- ACTIVE_COMPARATOR
- label
- Bupivacaine
- description
- Paracervical block. Bupivacaine 2,5 mg/ml; 20 ml
- interventionNames
- Drug: Bupivacaine
Primary outcomes (1)
- measure
- Changes in Cardiac Output as measured by LiDCOplus monitor.
- timeFrame
- 0-10 minutes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: • Clinical diagnosis of cervical pre-cancer Exclusion Criteria: * Pregnancy * Feeding mother * Bad nutritional state * Infection * Treatment for hypertension * Diabetes for many years or complications * Cardiovascular disease * Serious anemia * Cardial arrythmia * Serious liver-disease * Hypersensitivity to local anesthesia of amide-type
References
Publications (7)
- BACKGROUNDNesheim BI. Which local anesthetic is best suited for paracervical blocks? Acta Obstet Gynecol Scand. 1983;62(3):261-4. doi: 10.3109/00016348309155804. PMID 6353840
- BACKGROUNDPanda N, Verma RK, Panda NK. Efficacy and safety of high-concentration adrenaline wicks during functional endoscopic sinus surgery. J Otolaryngol Head Neck Surg. 2012 Apr;41(2):131-7. PMID 22569014
- BACKGROUNDZhao F, Wang Z, Yang J, Sun J, Wang Q, Xu J. Low-dosage adrenaline induces transient marked decrease of blood pressure during functional endoscopic sinus surgery. Am J Rhinol. 2006 Mar-Apr;20(2):182-5. PMID 16686385
- BACKGROUNDPalomaki O, Huhtala H, Kirkinen P. A comparative study of the safety of 0.25% levobupivacaine and 0.25% racemic bupivacaine for paracervical block in the first stage of labor. Acta Obstet Gynecol Scand. 2005 Oct;84(10):956-61. doi: 10.1111/j.0001-6349.2005.00709.x. PMID 16167911
- BACKGROUNDKerkkamp HE, Gielen MJ. Cardiovascular effects of epidural local anaesthetics. Comparison of 0.75% bupivacaine and 0.75% ropivacaine, both with adrenaline. Anaesthesia. 1991 May;46(5):361-5. doi: 10.1111/j.1365-2044.1991.tb09544.x. PMID 2035780
- BACKGROUNDde Leeuw MA, Slagt C, Hoeksema M, Zuurmond WW, Perez RS. Hemodynamic changes during a combined psoas compartment-sciatic nerve block for elective orthopedic surgery. Anesth Analg. 2011 Mar;112(3):719-24. doi: 10.1213/ANE.0b013e318206bc30. Epub 2010 Dec 14. PMID 21156977
- DERIVEDSjoeen GH, Falk RS, Hauge TH, Langesaeter E. Haemodynamic stability after paracervical block: A randomized, controlled, double-blind study comparing bupivacaine-adrenaline with bupivacaine. Acta Anaesthesiol Scand. 2019 Mar;63(3):373-380. doi: 10.1111/aas.13259. Epub 2018 Sep 10. PMID 30203440