Laparoscopic Gynecologic Surgery, Paracervical Block, Postoperative Pain
Conditions
Keywords
Paracervical Block, Laparoscopic Surgery, Postoperative Pain, Bupivacaine, Hysterectomy, Myomectomy, Randomized Trial
Brief summary
The purpose of this study is to determine the effectiveness of placing numbing medication around the cervix prior to performing laparoscopic gynecologic surgery in decreasing pain after surgery. The study focuses on laparoscopic hysterectomies and robotic-assisted myomectomies. It will assess whether patients who receive the medication experience less pain and require less pain medication post operatively and if it helps reduce the number of patients who require hospitalization for pain control following surgery.
Detailed description
A variety of traditionally open surgical procedures have recently become minimally invasive through the use of laparoscopic technology. Gynecologic surgeries are no exception. However, some gynecologic laparoscopic procedures are associated with significant post-operative pain, necessitating prolonged hospitalization, use of post-operative opioids, and in some cases, the development of chronic post-operative pain. Prolonged hospitalization and use of opioids pose important patient safety concerns, such as increased risk of hospital borne illnesses and medication errors; in addition, opioids may cause respiratory depression and addiction. Given the rising cost of health care there is also an economic incentive to eliminate the need for hospital admission due to post-operative pain. Preemptive analgesia involves nerve blockade or administration of pain medication systemically prior to incision to reduce post-procedure pain. Paracervical blockade is a form of preemptive analgesia. Paracervical blocks have been demonstrated to be safe and effective for obstetrical procedures in reducing post-operative pain since the 1970s. Recently they have also been shown to be efficacious for reducing post-operative pain in vaginal hysterectomy (Long et al, Int Urogynecol J (2009) 20:5-10). For the present investigation, we intend to study the effectiveness of paracervical blockade for laparoscopic and robotic-assisted laparoscopic gynecological surgery. We hypothesize that paracervical blockade prior to surgical incision will lessen levels of post-operative pain, reduce use of opioids, and decrease the number of patients requiring hospitalization for pain control. We also hypothesize that the effects may be longer lasting than the immediate post-operative period and may decrease the amount of time to return to normal activity after surgery. Using anecdotal evidence from the primary investigator, Dr. Ascher-Walsh the rate of hospitalization for laparoscopic hysterectomy (laparoscopic-assisted vaginal hysterectomy, total laparoscopic hysterectomy, laparoscopic assisted supracervical hysterectomy) is approximately 67%. In this study, we wish to decrease hospitalization with the paracervical block by 50%, thus obtaining an overall post-operative hospitalization rate of 33%. For robotic-assisted laparoscopic myomectomy, the rate of hospitalization is 50%. We wish to decrease this by 50% as well. Overall we are aiming to achieve a rate of 30% for post-operative hospitalization for pain control for laparoscopic hysterectomies and robotic myomectomies combined.
Interventions
Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.
Sponsors
Study design
Eligibility
Inclusion criteria
* Female * Age 18 or older * Scheduled for robotic-assisted laparoscopic myomectomy or laparoscopic hysterectomy, including total and supracervical hysterectomy, laparoscopic-assisted vaginal hysterectomy * Surgery being performed for benign disease
Exclusion criteria
* Male * Women under 18 years old * Pregnancy * Suspected or known malignant disease * Immunocompromised
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospital Admission for Postoperative Pain Control | Four hours after conclusion of surgery | Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | 1and 2 hour postoperatively | Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. |
| Postoperative Day Pain Medication Use | Postoperative days 0-10 | Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively. |
Countries
United States
Participant flow
Recruitment details
Patients undergoing laparoscopic surgery for benign indications were enrolled between 2011 and 2013
Participants by arm
| Arm | Count |
|---|---|
| Bupivacaine Subjects received a 20mL paracervical injection of 0.25% bupivacaine with 1:200000 units epinephrine prior to surgical incision. | 68 |
| Saline Subjects injected paracervically with 10 ml of normal saline prior to surgical incision. | 64 |
| Total | 132 |
Baseline characteristics
| Characteristic | Total | Bupivacaine | Saline |
|---|---|---|---|
| Admission Planned | 6 admissions | 5 admissions | 1 admissions |
| Age, Continuous | 48.1 years STANDARD_DEVIATION 9.2 | 48.4 years STANDARD_DEVIATION 9.2 | 47.8 years STANDARD_DEVIATION 9.3 |
| Body Mass Index | 28.1 kg/m^2 STANDARD_DEVIATION 6.4 | 27.2 kg/m^2 STANDARD_DEVIATION 5.7 | 29.1 kg/m^2 STANDARD_DEVIATION 6.9 |
| Parity 0 | 59 Participants | 21 Participants | 38 Participants |
| Parity 1 | 20 Participants | 10 Participants | 10 Participants |
| Parity 2 | 41 Participants | 22 Participants | 19 Participants |
| Parity ≥3 | 26 Participants | 15 Participants | 11 Participants |
| Preoperative Hematocrit | 36.7 % of cells STANDARD_DEVIATION 4.1 | 36.8 % of cells STANDARD_DEVIATION 4 | 36.6 % of cells STANDARD_DEVIATION 4.2 |
| Race/Ethnicity, Customized Asian | 7 Participants | 4 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 32 Participants | 12 Participants | 20 Participants |
| Race/Ethnicity, Customized Hispanic | 23 Participants | 13 Participants | 10 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 64 Participants | 36 Participants | 28 Participants |
| Sex: Female, Male Female | 132 Participants | 68 Participants | 64 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Surgical Indication Bleeding | 3 Participants | 2 Participants | 1 Participants |
| Surgical Indication Bleeding & pain | 9 Participants | 4 Participants | 5 Participants |
| Surgical Indication Fibroids | 16 Participants | 7 Participants | 9 Participants |
| Surgical Indication Fibroids & bleeding | 33 Participants | 19 Participants | 14 Participants |
| Surgical Indication Fibroids, bleeding & pain | 41 Participants | 18 Participants | 23 Participants |
| Surgical Indication Other | 3 Participants | 0 Participants | 3 Participants |
| Surgical Indication Pain | 5 Participants | 4 Participants | 1 Participants |
| Surgical Indication Prolapse | 22 Participants | 14 Participants | 8 Participants |
| Uterine Size | 14.0 weeks STANDARD_DEVIATION 5.1 | 13.7 weeks STANDARD_DEVIATION 5.5 | 14.2 weeks STANDARD_DEVIATION 4.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 68 | 0 / 64 |
| other Total, other adverse events | 17 / 68 | 16 / 64 |
| serious Total, serious adverse events | 1 / 68 | 0 / 64 |
Outcome results
Number of Participants With Hospital Admission for Postoperative Pain Control
Unplanned hospital admissions and the hospital admissions at the request of the patients for pain management
Time frame: Four hours after conclusion of surgery
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupivacaine | Number of Participants With Hospital Admission for Postoperative Pain Control | Unplanned admission | 23 Participants |
| Bupivacaine | Number of Participants With Hospital Admission for Postoperative Pain Control | Unplanned admission for pain | 10 Participants |
| Saline | Number of Participants With Hospital Admission for Postoperative Pain Control | Unplanned admission | 17 Participants |
| Saline | Number of Participants With Hospital Admission for Postoperative Pain Control | Unplanned admission for pain | 11 Participants |
Postoperative Day Pain Medication Use
Numbers of Patients Using Pain Medication on Postoperative Days 1-10. The subjects recorded at home the type and amount of pain medication they use for 10 days postoperatively.
Time frame: Postoperative days 0-10
Population: missing data from 5 participants in Bupivacaine Arm and 4 in Saline Arm
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 7 | 5 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 5 | 13 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 3 | 28 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 10 | 3 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 4 | 19 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 8 | 3 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 6 | 12 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 9 | 2 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 1 | 52 participants |
| Bupivacaine | Postoperative Day Pain Medication Use | Postoperative Day 2 | 43 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 6 | 13 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 5 | 15 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 9 | 6 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 3 | 33 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 7 | 11 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 4 | 26 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 2 | 39 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 1 | 52 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 8 | 10 participants |
| Saline | Postoperative Day Pain Medication Use | Postoperative Day 10 | 7 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 2 | 24 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 6 | 15 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 7 | 16 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 8 | 12 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 9 | 9 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 1 | 17 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 3 | 29 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 4 | 28 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 5 | 19 participants |
| Saline Group | Postoperative Day Pain Medication Use | Postoperative Day 10 | 9 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 2 | 18 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 1 | 10 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 10 | 10 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 5 | 28 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 8 | 12 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 9 | 11 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 7 | 16 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 3 | 22 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 6 | 24 participants |
| Saline Discharged Participants | Postoperative Day Pain Medication Use | Postoperative Day 4 | 26 participants |
Postoperative Pain Score
Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff.
Time frame: 1and 2 hour postoperatively
Population: This doesn't include hospitalization for reasons other than pain management.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine | Postoperative Pain Score | 1 hour postoperative | 4.7 units on a scale | Standard Deviation 2.9 |
| Bupivacaine | Postoperative Pain Score | 2 hours postoperative | 4.3 units on a scale | Standard Deviation 2.5 |
| Saline | Postoperative Pain Score | 2 hours postoperative | 2.7 units on a scale | Standard Deviation 1.8 |
| Saline | Postoperative Pain Score | 1 hour postoperative | 3.9 units on a scale | Standard Deviation 2.2 |
| Saline Group | Postoperative Pain Score | 1 hour postoperative | 5.1 units on a scale | Standard Deviation 2 |
| Saline Group | Postoperative Pain Score | 2 hours postoperative | 4.5 units on a scale | Standard Deviation 2.4 |
| Saline Discharged Participants | Postoperative Pain Score | 1 hour postoperative | 4.5 units on a scale | Standard Deviation 2.4 |
| Saline Discharged Participants | Postoperative Pain Score | 2 hours postoperative | 3.8 units on a scale | Standard Deviation 2.3 |
Postoperative Pain Score
Postoperative pain levels assessed using the visual analogue pain scale. This scale pairs faces with numbers 1-10, with 1 being no pain and 10 being extreme pain. In the PACU pain assessed using this scale by the nursing staff. On postoperative days 1 and 2 the subjects self-reported their pain level.
Time frame: 1, 2, 4 hour postoperatively, Day 1 post operatively, Day 2 postoperative
Population: Only those subjects with pain analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupivacaine | Postoperative Pain Score | 2 hours postoperative | 3.37 units on a scale | Standard Deviation 2.19 |
| Bupivacaine | Postoperative Pain Score | Day 1 postoperative | 3.80 units on a scale | Standard Deviation 2.53 |
| Bupivacaine | Postoperative Pain Score | 4 hours postoperative | 3.83 units on a scale | Standard Deviation 2.57 |
| Bupivacaine | Postoperative Pain Score | Day 2 postoperative | 3.16 units on a scale | Standard Deviation 2.34 |
| Bupivacaine | Postoperative Pain Score | 1 hour postoperative | 4.30 units on a scale | Standard Deviation 2.55 |
| Saline | Postoperative Pain Score | Day 2 postoperative | 3.37 units on a scale | Standard Deviation 2.39 |
| Saline | Postoperative Pain Score | 1 hour postoperative | 4.69 units on a scale | Standard Deviation 2.29 |
| Saline | Postoperative Pain Score | 2 hours postoperative | 4.01 units on a scale | Standard Deviation 2.32 |
| Saline | Postoperative Pain Score | 4 hours postoperative | 4.35 units on a scale | Standard Deviation 2.43 |
| Saline | Postoperative Pain Score | Day 1 postoperative | 4.35 units on a scale | Standard Deviation 2.14 |