Clinical trial · Interventional
Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
A Randomized Trial of Buffered vs Nonbuffered Lidocaine With Epinephrine for Cervical Loop Excision
NCT01405768CI-TRIAL-00015224completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Women undergoing a LEEP procedure who receive lidocaine buffered with sodium bicarbonate for their cervical block will experience less injection pain than women who receive plain lidocaine.
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 |
|---|---|---|---|
| Uterine Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Non-buffered lidocaine | Drug | — | UNRESOLVED |
| sodium bicarbonate buffered lidocaine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lidocaine Arm
- description
- Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
- interventionNames
- Drug: Non-buffered lidocaine
- type
- EXPERIMENTAL
- label
- Buffered Lidocaine
- description
- Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.
- interventionNames
- Drug: sodium bicarbonate buffered lidocaine
Primary outcomes (2)
- measure
- Injection Pain Score (Mean)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * antecedent biopsy read as * cervical intraepithelial neoplasia (CIN) grade 2 or 3 or microinvasive cancer * adenocarcinoma in situ * persistent CIN 1 * antecedent pap read as * high grade squamous intraepithelial lesion * atypical glandular cells * persistent low grade squamous intraepithelial lesion Exclusion Criteria: * anatomy unsuitable for safe office loop excision based on operator judgement * inability to tolerate procedure under local anesthesia * pregnancy * age less than 18 years * inability to understand spoken or written English * refusal of consent * prisoner * mental incapacity * anticoagulant or antiplatelet therapy, or known bleeding diathesis * use of analgesics other than over the counter medications(OTC meds include NSAIDS or Tylenol) within 7 days of scheduled LEEP
References
Publications (7)
- BACKGROUNDRuegg TA, Curran CR, Lamb T. Use of buffered lidocaine in bone marrow biopsies: a randomized, controlled trial. Oncol Nurs Forum. 2009 Jan;36(1):52-60. doi: 10.1188/09.ONF.52-60. PMID 19136338
- BACKGROUNDSharma T, Gopal L, Shanmugam MP, Bhende P, George J, Samanta TK, Mukesh BN. Comparison of pH-adjusted bupivacaine with a mixture of non-pH-adjusted bupivacaine and lignocaine in primary vitreoretinal surgery. Retina. 2002 Apr;22(2):202-7. doi: 10.1097/00006982-200204000-00011. PMID 11927854
- BACKGROUNDFitton AR, Ragbir M, Milling MA. The use of pH adjusted lignocaine in controlling operative pain in the day surgery unit: a prospective, randomised trial. Br J Plast Surg. 1996 Sep;49(6):404-8. doi: 10.1016/s0007-1226(96)90011-9. PMID 8881789
- BACKGROUNDBurns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043. PMID 16384767
- BACKGROUNDYounis I, Bhutiani RP. Taking the 'ouch' out - effect of buffering commercial xylocaine on infiltration and procedure pain - a prospective, randomised, double-blind, controlled trial. Ann R Coll Surg Engl. 2004 May;86(3):213-7. doi: 10.1308/003588404323043382. PMID 15140310
- BACKGROUNDMasters JE. Randomised control trial of pH buffered lignocaine with adrenaline in outpatient operations. Br J Plast Surg. 1998 Jul;51(5):385-7. doi: 10.1054/bjps.1997.0293. PMID 9771366
- BACKGROUNDOrlinsky M, Hudson C, Chan L, Deslauriers R. Pain comparison of unbuffered versus buffered lidocaine in local wound infiltration. J Emerg Med. 1992 Jul-Aug;10(4):411-5. doi: 10.1016/0736-4679(92)90269-y.