Laparoscopic Tubal Clip Sterilization Under Local Anesthesia*

Vol. 25, No.9, September 1974 Printed in U.S.A.

FERTILITY AND STERILITY Copyright @ 1974 The American Fertility Society

LAP AROSCOPIC TUBAL CLIP STERILIZATION UNDER LOCAL ANESTHESIA * JOHN I. FISHBURNE, JR.. M.D., KHAIRIA F. OMRAN, M.D., DR. PH., JAROSLAV F. HULKA, M.D., JACK P. MERCER, M.D., AND DAVID A. EDELMAN, PH.D. Departments of Obstetrics-Gynecology and Anesthesiology, The School of Medicine, University of North Carolina, Chapel Hill, North Carolina 27514

Clinical investigation of the laparoscopic spring clip sterilization technique was begun at the University of North Carolina at Chapel Hill in September 1972.1 Local anesthesia was selected because of the ease and rapidity with which the laparoscopic procedure could be done. It became apparent, however, that although adequate anesthesia could be obtained for production of nitrous oxide pneumoperitoneum and for trocar insertion, application of the clips was associated with sharp, though usually transient, pain. In an attempt to eliminate this pain, local anesthetic solution was sprayed or flowed onto the fallopian tubes via a needle through the anterior abdominal wall. Our clinical impression was that this approach largely eliminated the pain of clip application, and led us to modify the clip applying laparoscope so as to include a local anesthetic injection channel (Fig. 1). In order to evaluate the possible benefit of tubal application of a local anesthetic agent, the following study was undertaken.

study. A protocol (Fig. 2) was devised to collect data on drugs used and pain experienced by the patient. A pain scale of 0 (no pain) to 4 (extremely severe pain) was employed. The pain rating scale was explained to the patient before the start of the procedure, and she was asked to evaluate the severity of pain

MATERIALS AND METHODS

The first 149 women to participate in the outpatient laparoscopic clip sterilization program were the subjects for this Received October 24, 1973.

*Supported by the Agency for International Development through the International Fertil. ity Research Program.

FIG. 1. The clip-applying laparoscope with stopcock, Luer connection, and syringe for injection of local anesthetic solution.

762

Vol. 25, No.9

TUBAL CLIP STERILIZATION

763

LAPAROSCOPY LOCAL ANESTHESIA EVALUATION SHEET

NAME:

DATE:

HOSPITAL UNIT NUMBER:

AGE:

Circle one: Lap aros copy: clip Tube Sprayed: R Analgesia:

cautery L

clip + TA Gas Used: N20

(1)

VALIUM:

(2)

FENTANYL:

(3)

PARACERVICAL BLOCK:

ComElications:

(1) (2) (3)

(4)

10 mg

0.2 mg.

0.15 mg

yes

yes yes yes

diagnostic lap.

20 mg

15 mg

0.1 mg

NAUSEA: VOMITING: SYNCOPE: OTHER:

cautery + TA C02

no

no no no

Analgesia Evaluation:

•

Circle One:

single puncture

dual puncture

Explanation of numbers used in rating below:

no pain slight pain 2 = moderate pain severe pain 3 4 = extremely severe pain 0 1

Circle one number for each rating.

•

1.

Intravenous Insertion:

0

1

2

3

4

2.

Paracervical Block:

0

1

2

3

4

3.

Skin Elevation:

0

1

2

3

4

4.

Insuff lation:

0

1

2

3

4

5.

Trochar Insertion:

0

1

2

3

4

6.

Uterine Motion:

0

1

2

3

4

7.

Tube Pain Rating:

R= 0

1

2

3

4

L = 0

1

2

3

4

8.

Overall Pain Rating:

0

1

2

3

4

9.

Patient Acceptance:

0

1

2

3

4

Would you recommend this procedure to a friend?

yes

no

Comments:

FIG. 2. Protocol for collection of data on effectiveness of local anesthesia and systemic analgesia and/or sedation for outpatient laparoscopy.

FISHBURNE, ET AL

764

September 1974

experienced during insertion of the intravenous catheter. Subsequently during the operative procedure, pain ratings were obtained at each surgical step as described in the protocol. Data from the protocol sheets were later encoded on punch cards and analyzed. In order to assess the effects of a sedative and an analgesic drug, 10 mg of diazepam and 0.1 mg of fentanyl were withheld or administered intravenously, alone or together on a random basis. Following this premedication, 10 to 15 ml of 1% lidocaine was infiltrated into the skin of the inferior umbilical fold and the underlying fascia and peritoneum. A small incision was then made and the Verres needle was passed into the peritoneal cavity. After nitrous oxide pneumoperitoneum was produced, the laparoscope trocar and laparoscope were inserted and the pelvic organs were visualized. Two milliliters of 1% or 4% lidocaine solution were then applied to neither, one, or both fallopian tubes. Paracervical block (PCB) with 20 ml of 1% lidocaine was used for the first ten patients undergoing sterilization and in an additional 17 patients for which therapeutic abortion was also performed.

of patients. No lidocaine was applied to 147 tubes, while 151 received 1 or 2 ml of 1% or 4% lidocaine.

TABLE 1. Systemic Sedation and/or Analgesia

The distributions of pain ratings for unanesthetized and anesthetized tubes were significantly different (P
Drug

Diazepam Fentanyl Diazepam and fentanyl No drug Total

No. of patients

13 32 90 14 149

% of patients

8.7

21.5 60.4 9.4 100.0

Table 1 illustrates how patients were grouped with respect to drugs administered. When, in the opinion of the anesthetist, the patient required more sedation or analgesia, additional drug was given without regard to the protocol. Since pain ratings were obtained for clip application to each fallopian tube, the data were analyzed with respect to numbers of tubes, rather than numbers

RESULTS

To assess the effects of tubal anesthesia with or without the administration of diazepam and/or fentanyl on the patient's tubal pain ratings, the mean pain ratings were compared. The mean pain rating when 1% or 4% lidocaine was applied was independent (P>0.10) of the dose of diazepam and/or fentanyl administered (Table 2). However, for unanesthetized tubes the mean pain rating depended (P<0.10) on both the diazepam and fentanyl dose. The mean pain rating was higher when no drugs were administered (Table 3). For any dose of diazepam and/or fentanyl the mean pain ratings for 1% (0.27) and 4% (0.13) lidocaine were not significantly different (P>0.10). The mean pain rating of 0.21 for anesthetized tubes was significantly lower (p<0.01) than that for unanesthetized tubes when neither diazepam nor fentanyl was administered (1. 79) or when either or both of these drugs were administered (1.14) (Table 4).

For 102 (68.5%) of the patients only one tube was anesthetized, in which case the patient served as her own control. For 43 (42.1%) of these patients both tubes were rated equally, and for the remaining 59 patients the anesthetized tube received the lower rating. In no case did the unanesthetized tube receive a

I

Vol. 25, No.9

TUBAL CLIP STERILIZATION

765

TABLE 2. Mean Tubal Pain Ratings for Anesthetized Tubes at Various Doses of Diazepam and Fentanyl Fentanyla Dose Diazepam

(mg)

None 5-7.5 10-15

None

.05-.10

0.14 (14) 0.00 (2) 0.30 (10)

0.20 (25) 0.32 (31) 0.18 (50)

>.10

0.25 (4) 0.67 (3) 0.00 (12)

aNumbers in parentheses represent the number of tubes.

lower pain rating than the anesthetized one. PCB had no effect (p>0.10) on mean tubal pain rating, and this was independent of whether or not tubal anesthesia was employed (Table 5).

or pneumoperitoneum. Therefore, by reducing the pain of tubal manipulation, it has become possible to employ little systemic analgesia and/or sedation. Currently, 0.1 mg of fentanyl alone suffices for the entire laparoscopic procedure. Consequently, recovery is rapid; most patients are discharged within 2 hours.

DISCUSSION

After this study was initiated (September 1972), Alexander et a1 2 reported a similar approach to anesthesia of the fallopian tubes for laparoscopic sterilization by electrocautery. They waited 2 minutes for maximum anesthesia using dyclonine (Dyclone); however, we found anesthesia to occur almost immediately with 1% or 4% lidocaine. The anesthesia produced with lidocaine also seems to be of short duration. Following initial application of the anesthetic drug to both tubes, surgery must proceed rapidly lest anesthesia disappear from the second tube before surgery on the first has been completed. If this occurs the anesthetic drug should be reapplied before continuing with the second tube. With some consistency the highest pain ratings were recorded for clip application to unanesthetized tubes, as compared with the pain associated with intravenous catheter placement, uterine motion, trocar insertion, skin elevation,

Vasovagal reflex stimulation with resultant hypotension and bradycardia occurred in 3.4% of patients undergoing clip sterilization. It is of interest that none of the 27 patients who had paracervical block (PCB) in addition to local infiltration anesthesia experienced these symptoms. Presumably vagal stimulation arising from uterine motion and tubal compression is blocked by PCB. A tropine given prophylactically also blccks the vasovagal reflex, but the low frequency of this complication does not justify routine use of the drug. In this series, pain after recovery of local sensation o·ccurred independently of the sedative or analgesic drug employed (P>0.10). However, pain rates were slightly higher for patients not administered fentanyl (51.9% vs 32.0%). Vomiting during the early recovery period occurred in 4.1% of patients. This

TABLE 3. Mean Tubal Pain Ratings for Unanesthetized Tubes at Various Doses of Diazepam and Fentanyl Fentanyla Dose Diazepam

(mg)

None 5-7.5 10-15

None

.05-.10

>.10

1.79 (14)

0.96 (27) 1.44 (9) 1.19 (60)

1.00 (8) 2.00 (1) 1.43 (14)

-

(0)

0.86 (14)

aNumbers in parentheses represent the number of tubes.

FISHBURNE, ET AL

766

September 1974

TABLE 4. Mean Tubal Pain Ratings and Distribution for Anesthetized and Unanesthetized Tubes With or Without the Administration of Diazepam and Fentanyl Treahnent a T.A. (with or without D and/or F) No. %

Pain rating

NoT.A. (without D and/or F) No. %

NoT.A. (with D and/or F) No. %

NoT.A. (with or without D and/or F) No. %

0 1 2 3 4

125 20 6 0 0

82.8 13.2 4.0 0 0

4 1 5 2 2

28.6 7.1 35.7 14.3 14.3

43 45 30 13 2

32.3 33.8 22.6 9.8 1.5

47 46 35 15 4

32.0 31.3 23.8 10.2 2.7

Total

151

100.0

14

100.0

133

100.0

147

100.0

Mean pain rating

0.21

1.79

1.14

1.20

aT.A. = tubal anesthesia; D = diazepam; F = fentanyl.

complication was also unrelated to dose or drug employed. Follow-up data obtained on 139 patients indicated that 119 (85.4%) of these had resumed their usual activities within 3 days after the procedure. When questioned, 142 patients (95.3%) expressed their approval of the procedure by stating they would recommend it to a friend. In conclusion, direct tubal application of an anesthetic solution significantly diminished pain of the laparoscopic clip sterilization procedure. By reducing the amount of systemic analgesia and/or sedation required, this technique has led to decreased morbidity and rapid recovery from anesthesia. TABLE 5 Mean Tubal Pain Rating for Anesthetized and Unanesthetized Tubes With or Without Paracervical Block Tubal anesthesia a

PCBb NoPCBb

None

1 % or 4% lidocaine

1.21 (29) 1.20 (118)

0.28 (25) 0.20 (126)

aNumbers in parentheses represent the number of tubes. bPCB = paracervical block.

patient was asked to rate the pain associated with clip application on a scale of o to 4. Patients had 1% or 4% lidocaine solution applied to neither, one, or both fallopian tubes on a random basis. The data were analyzed by comparing the mean pain ratings for anesthetized tubes with those for unanesthetized tubes. When no topical lidocaine was employed, the mean pain rating was 1.20 on a 0 to 4 scale. Mean ratings of 0.27 and 0.13 were noted respectively when 1% and 4% lidocaine were applied. The difference between some topical lidocaine and none was significant at the P
SUMMARY

1.

This study was designed to evaluate the effectiveness of a topical local anesthetic solution sprayed on the fallopian tubes prior to laparoscopic application of tubal clips. One hundred forty-nine women participated in the study. Each

2.

REFERENCES Hulka JF, Fishburne Jr, Mercer JP, et al: Laparoscopic sterilization with a spring clip: a report of the first fifty cases. Am J Obstet Gynecol 116: 715, 1973 Alexander GD, Goldrath M, Brown EM, et al: Outpatient laparoscopic sterilization under local anesthesia. Am J Obstet Gynecol 116: 1065, 1973

~