Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

NCT01405768 | Completed Phase 2 Results

• 1 other identifier: 201104269
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Uterine Cervical Dysplasia

Outcome Measures

Primary Outcomes (2)

• Injection Pain Score (Mean)

  A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block. Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability. Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.

  Within 30 minutes of completion of procedure

• Injection Pain Score (Median)

  A Likert visual analog scale will be used to document each study participant's level of pain experienced during injection of the cervical block. Within 30 minutes of completion of the procedure and after instruction by the investigators, women reported the intensity of their pain by marking single lines across 100-mm Likert visual analog scales. Scales did not include hashmarks or internal descriptors, as these have been shown to bias responses and diminish reliability. Patient marks on 100-mm Likert scale lines were measured, and a score was determined by the length marked off in millimeters. Patients who wrote "no pain" were considered to have marked 0 mm.

  Within 30 minutes of completion of the procedure

Secondary Outcomes (2)

• Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)

  Within 30 minutes of completion of procedure

• Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)

  Within 30 minutes of completion of procedure

Study Arms (2)

Lidocaine Arm

ACTIVE COMPARATOR

Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.

Drug: Non-buffered lidocaine

Buffered Lidocaine

EXPERIMENTAL

Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.

Drug: sodium bicarbonate buffered lidocaine

Interventions

sodium bicarbonate buffered lidocaine DRUG

8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.

Buffered Lidocaine

Non-buffered lidocaine DRUG

Lidocaine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• Ruegg 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 BACKGROUND

• Sharma 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 BACKGROUND

• Fitton 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 BACKGROUND

• Burns 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 BACKGROUND

• Younis 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 BACKGROUND

• Masters 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 BACKGROUND

• Orlinsky 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.

  PMID: 1430977 BACKGROUND

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

* Small sample - may have missed a significant difference when one really exists * Procedures performed by 2nd year residents vs. procedure performed by more skilled surgeon (less pain) * Used needle extenders/27-gauge needles vs. Potocki needles

Results Point of Contact

• Title: L. Stewart Massad, M.D.
• Organization: Washington University School of Medicine

massadl@wudosis.wustl.edu

314-362-3181

Study Officials

• L. Stewart Massad, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2011
• First Posted: July 29, 2011
• Study Start: July 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 28, 2014
• Results First Posted: July 28, 2014

Record last verified: 2014-06

Locations

US (1)