Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Uterine Cervical Dysplasia

Precancerous Conditions

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Cervical Intraepithelial Neoplasia

Anti-Arrhythmia Agents

Channel Blockers

Central Nervous System Depressants

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Lidocaine

Epinephrine

Racepinephrine

Epinephryl borate

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

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

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

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

sodium bicarbonate buffered lidocaine

Non-buffered lidocaine

L. Stewart Massad, M.D.

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.

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.

Buffered Lidocaine for Loop Electrosurgical Excision Procedures (LEEPs)

A Randomized Trial of Buffered vs Nonbuffered Lidocaine With Epinephrine for Cervical Loop Excision

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.

A Likert visual analog scale will be used to determine the overall pain experienced by each study participant including injection pain, procedural pain, and cramping.

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.

Washington University School of Medicine

Lidocaine Arm

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

sodium bicarbonate buffered lidocaine: 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

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

African American

White

Hispanic/Latina

Other

Race/Ethnicity, Customized

United States

Region of Enrollment

Parity indicates the number of \>20-week births (including viable and non-viable; i.e., stillbirths). Pregnancies consisting of multiples, such as twins or triplets, count as one birth for the purpose of this notation.

Parity

HSIL

CIN 2

CIN 3

Persistent CIN 1

HSIL = High grade squamous intraepithelial lesion

CIN 2 = Cervical squamous intraepithelial neoplasia 2

CIN 3 = Cervical squamous intraepithelial neoplasia 2

AIS = Adenocarcinoma in situ

Persistent CIN 1 = Persistent cervical squamous intraepithelial neoplasia 1

Indication

Ectocervix only

Ectocervix and endocervix

Procedure type

Number of passes

15 x 12

20 x 12

Ectocervical loop size (in mm)

10 x 10

10 x 8

8 patients in the Lidocaine arm had the endocervical loop used.

11 patients in the Buffered Lidocaine arm had the endocervical loop used.

Endocervical loop size (in mm)

0 mL

1-5 mL

6-10 mL

>10 mL

Estimated blood loss (in mL)

6-9 mL

10 mL

Anesthetic volume (in mL)

4 women from the lidocaine arm who did not complete the questionnaire correctly were excluded from analysis

* 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

Spots Global Cancer Trial Database for sodium bicarbonate buffered lidocaine