Pain management for tubal sterilization by hysteroscopy

Abstract

Background: Tubal sterilization by hysteroscopy involves inserting a foreign body in both fallopian tubes. Over a three-month period, the tubal lumen is occluded by tissue growth stimulated by the insert. Tubal sterilization by hysteroscopy has advantages over laparoscopy or mini-laparotomy, including the avoidance of abdominal incisions and the convenience of performing the procedure in an office-based setting. Pain, an important determinant of procedure acceptability, can be a concern when tubal sterilization is performed in the office.

Objectives: To review all randomized controlled trials that evaluated interventions to decrease pain during tubal sterilization by hysteroscopy.

Search methods: From January to March 2011, we searched the computerized databases of MEDLINE, POPLINE, CENTRAL, EMBASE, LILACS, and CINAHL for relevant trials. We searched for current trials via Clinicaltrials.gov. We also examined the reference lists of pertinent articles and wrote to known investigators for information about other published or unpublished trials.

Selection criteria: We included all randomized controlled trials that evaluated pain management at the time of sterilization by hysteroscopy. The intervention could be compared to another intervention or placebo.

Data collection and analysis: Initial data were extracted by one review author. A second review author verified all extracted data. Whenever possible, the analysis was conducted with all women randomized and in the original assigned groups. Data were analyzed using RevMan software. Pain was measured using either a 10-cm or 100-point visual analog scale (VAS). When pain was measured at multiple points during the procedure, the overall pain score was considered the primary treatment effect. If this was not measured, a summation of all pain scores for the procedure was considered to be the primary treatment effect. For continuous variables, the mean difference with 95% confidence interval was computed.

Main results: Two trials met the inclusion criteria. The total number of participants was 167. Using a 10-cm VAS to measure pain, no significant difference emerged in overall pain for the entire procedure between women who received a paracervical block with lidocaine versus normal saline (mean difference -0.77; 95% CI -2.67 to 1.13). No significant difference in pain score was noted at the time of injection of study solution to the anterior lip of the cervix (mean difference -0.6; 95% CI -1.3 to 0.1), placement of the device in the tubal ostia (mean difference -0.60; 95% CI -1.8 to 0.7), and postprocedure pain (mean difference 0.2; 95% CI -0.8 to 1.2). Procedure time (mean difference -0.2 minutes; 95% CI -2.2 to 1.8 minutes) and successful bilateral placement (OR 1.0; 95% CI 0.19 to 5.28) was not significantly different between groups. During certain portions of the procedure, such as placement of the tenaculum (mean difference -2.03; 95% CI -2.88 to -1.18), administration of the paracervical block (mean difference -1.92; 95% CI -2.84 to -1.00), and passage of the hysteroscope through the external (mean difference -2.31; 95% CI -3.30 to -1.32) and internal os (mean difference -2.31; 95% CI -3.39 to -1.23), use of paracervical block with lidocaine resulted in lower pain scores.Using a 600-point scale calculated by adding 100-point VAS scores from six different portions of the procedure, no significant difference emerged in overall pain between women who received intravenous conscious sedation versus oral analgesia (mean difference -23.00; CI -62.02 to 16.02). Using a 100-point VAS, no significant difference emerged at the time of speculum insertion (mean difference 4.0; 95% CI -4.0 to 12.0), cervical injection of lidocaine (mean difference -1.8; 95% CI -10.0 to 6.4), insertion of the hysteroscope (mean difference -8.7; 95% CI -19.7 to 2.3), placement of the first device (mean difference -4.4; 95% CI -15.8 to 7.0), and removal of the hysteroscope (mean difference 0.9; 95% CI -3.9 to 5.7). Procedure time (mean difference -0.2 minutes; 95% CI -2.0 to 1.6 minutes) and time in the recovery area (mean difference 3.6 minutes; 95% CI -11.3 to 18.5 minutes) was not different between groups. However, women who received intravenous conscious sedation had lower pain scores at the time of insertion of the second tubal device compared to women who received oral analgesia (mean difference -12.60; CI -23.98 to -1.22).

Authors' conclusions: The available literature is insufficient to determine the appropriate analgesia or anesthesia for sterilization by hysteroscopy. Compared to paracervical block with normal saline, paracervical block with lidocaine reduced pain during some portions of the procedure. Intravenous sedation resulted in lower pain scores during insertion of the second tubal device. However, neither paracervical block with lidocaine nor conscious sedation significantly reduced overall pain scores for sterilization by hysteroscopy.

1.1. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 1 Self‐ reported overall pain.

1.2. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 2 Pain with placement injection to anterior lip of the cervix.

1.3. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 3 Pain with placement of tenaculum.

1.4. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 4 Pain with placement of the paracervical block at 4 o'clock and 8 o'clock.

1.5. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 5 Pain with passage of hysteroscope through external os.

1.6. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 6 Pain with passage of hysteroscope through internal os.

1.7. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 7 Pain with implant placement.

1.8. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 8 5‐minute postprocedure pain.

1.9. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 9 Procedure time (minutes).

1.10. Analysis

Comparison 1 Paracervical block with normal saline 11 mL versus 1% lidocaine 11 mL, Outcome 10 Placement of bilateral device.

2.1. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 1 Total pain score (scores for entire procedure combined).

2.2. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 2 Pain with speculum insertion.

2.3. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 3 Pain with cervical injection.

2.4. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 4 Pain with insertion of hysteroscope.

2.5. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 5 Pain with placement of first insert.

2.6. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 6 Pain with placement of second insert.

2.7. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 7 Pain with removal of hysteroscope.

2.8. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 8 Procedure time (minutes).

2.9. Analysis

Comparison 2 Conscious sedation versus oral analgesia, Outcome 9 Time in recovery area (minutes).