Clinical trial NCT01405768: Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)
Official title: A Randomized Trial of Buffered vs Nonbuffered Lidocaine With Epinephrine for Cervical Loop Excision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uterine Cervical Dysplasia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Specific aims:

1. To determine whether buffering the agent used for intracervical anesthetic at the time of cervical loop excision reduces injection-related pain. (Hypothesis: buffering significantly reduces injection-related pain.)
2. To determine whether other components of pain from LEEP (procedural pain, and cramping) can be reduced by buffering of intracervical anesthetic among women undergoing cervical loop excision. (Hypothesis: only injection pain will be reduced by buffering, as procedural pain will be reduced by lidocaine equally in both arms and cramping will not be reduced in either arm.)

Background:

Although cervical cancer rates have been dramatically reduced by Pap test screening and the eradication of precursors, more than 100,000 U.S. women develop premalignant cervical lesions each year that require treatment (1). The cervical loop electrosurgical excision procedure (LEEP) is the most common therapy for CIN among U.S. gynecologists. LEEP is performed using one or more 1-2 cm electrosurgical diathermy loops to excise involved and at-risk cervical epithelium including underlying stroma containing glands. Destroying this tissue eliminates cells infected with human papillomavirus, the proximate cause of cervical cancer, and radically reduces the risk of later developing cervical cancer (2, 3).

LEEP is usually performed as an outpatient procedure using intracervical anesthesia, most commonly combining lidocaine as an anesthetic agent with epinephrine as a hemostatic agent; final hemostasis is achieved using electrosurgical fulguration and topical hemostatic agents (4). Prior literature has suggested that pain from LEEP has 3 components: pain from injection of the anesthetic combination, pain from the excision, and cramping from reflex uterine contractions (5). While cramping can be controlled with oral nonsteroidal anti-inflammatory agents, injection and procedural pain are not. Most women categorize the pain of LEEP as 3-7 on a 0-10 Likert scale (5, 6).

Studies of dermal and ocular anesthesia and bone marrow biopsy have found that buffering of acidic local anesthetic agents reduces injection pain (7-14), with up to 66% reduction in pain and significant results in randomized trials involving 30-50 participants. However, the use of buffered lidocaine has not yet been tested for LEEPs. The principal investigator has used both forms of anesthesia and considers both acceptable forms of therapy; he is unaware of any evidence to support the superiority of either arm.

Eligibility criteria: 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

Primary outcomes:
measure: Injection Pain Score (Mean)
timeFrame: Within 30 minutes of completion of procedure
measure: Injection Pain Score (Median)
timeFrame: Within 30 minutes of completion of the procedure
Secondary outcomes:
measure: Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Mean)
timeFrame: Within 30 minutes of completion of procedure
measure: Overall LEEP Procedure Pain Including Procedural Pain and Cramping (Median)
timeFrame: Within 30 minutes of completion of procedure
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: L. Stewart Massad, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.