Hysterectomy
Conditions
Keywords
Laparoscopy, Superior hypogastric plexus block
Brief summary
The goal of this study is to assess the efficacy of a superior hypogastric plexus block (SHPB) for pain relief following a laparoscopic hysterectomy.
Detailed description
The objective of this study is to assess the efficacy of a SHPB for pain relief following laparoscopic hysterectomy. The superior hypogastric plexus lies in the presacral space and supplies autonomic innervation to the central pelvis. This plexus is suspected to play a role in postoperative pain following a hysterectomy. The investigators hypothesize that a SHPB using the anesthetic bupivacaine will reduce patients' pain scores and opioid consumption following a laparoscopic hysterectomy. Intraoperative and immediate postoperative opioid consumption will be collected from the Medication Administration Record by the nursing staff. The nursing staff will also be asked to complete a recovery worksheet that details the Visual Analog Scale pain score and opioid administration on admission to the recovery unit and every postoperative hour until six hours or the patient is discharged. Patients will also be asked to complete a daily diary for one week following the procedure, which details their pain level and daily opioid consumption. Patients will be followed for thirty days after surgery to assess for the occurrence of any postoperative complications. Detailed patient and procedure characteristics including age, race, body mass index, parity, surgical history, surgery indication, procedure type, and surgical approach will also be collected.
Interventions
10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
Sponsors
University of North Carolina
George Washington University
Jon I. Einarsson
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Patients will be blinded to the treatment arm; however, the surgeon will know if a patient has been randomized to receive the block during the hysterectomy.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Over age 18 * English Speaking * Able to provide informed consent * Undergoing laparoscopic hysterectomy for benign indications
Exclusion criteria
* Planned laparotomy incision * Planned procedure that requires dissection of the presacral space * Allergy to block medication (s) * Known or suspected malignancy * Non-English speaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Scores | Admission to recovery unit and every hour after for 2 hours | The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Opioid Use | Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery | Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption. |
| Postoperative Pain Scores | Discharge to 1 week after surgery, assessed up to 1 week after surgery | Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Superior Hypogastric Plexus Block Prior to the laparoscopic hysterectomy and any additional procedures, the SHPB will be performed on patients in the treatment arm. The block will contain 10 mL of 0.25% bupivacaine hydrochloride (Bupivacaine; 2.5 mg/mL = 25 mg). The anesthetic works by blocking nerve conduction and the steroid by reducing inflammation. The injection will be performed by tenting the presacral peritoneum, aspirating with a laparoscopic needle-tip syringe to ensure extravascular placement, and injecting the block.
Bupivacaine Hydrochloride 0.25% Injection Solution: 10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg) | 50 |
| No Block Patients in the control arm will undergo the hysterectomy with no intervention. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Superior Hypogastric Plexus Block | Total | No Block |
|---|---|---|---|
| Age, Continuous | 44 years | 45 years | 45 years |
| Body Mass Index (BMI) | 28.7 kg/m^2 | 29.5 kg/m^2 | 30.5 kg/m^2 |
| Gravidity | 2 Pregnancies | 2 Pregnancies | 2 Pregnancies |
| Indication for Surgery Abnormal Uterine Bleeding | 10 Participants | 23 Participants | 13 Participants |
| Indication for Surgery Fibroids | 25 Participants | 45 Participants | 20 Participants |
| Indication for Surgery Other | 3 Participants | 4 Participants | 1 Participants |
| Indication for Surgery Pelvic pain | 12 Participants | 28 Participants | 16 Participants |
| Parity | 2 Pregnancies | 2 Pregnancies | 2 Pregnancies |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black/African American | 8 Participants | 22 Participants | 14 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Hispanic | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 3 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White/Caucasian | 35 Participants | 64 Participants | 29 Participants |
| Region of Enrollment United States | 50 Participants | 100 Participants | 50 Participants |
| Sex: Female, Male Female | 50 Participants | 100 Participants | 50 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
Primary
Postoperative Pain Scores
The primary outcome will be immediate postoperative patient pain scores using the Visual Analog Scale (VAS) in the recovery unit. Postoperative pain scores will be collected every one hour, on a scale from 1 to 10. Higher score indicates greater pain intensity. The score reported here is the mean VAS score in the first 2 hours.
Time frame: Admission to recovery unit and every hour after for 2 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Superior Hypogastric Plexus Block | Postoperative Pain Scores | 3.9 score on a scale |
| No Block | Postoperative Pain Scores | 4.7 score on a scale |
Secondary
Postoperative Opioid Use
Patients will be asked to complete a daily diary for one week that records their daily postoperative opioid consumption.
Time frame: Admission to recovery unit to 1 week post op, assessed up to 1 week after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Superior Hypogastric Plexus Block | Postoperative Opioid Use | postoperative day 2 | 0 milligrams morphine equivalents |
| Superior Hypogastric Plexus Block | Postoperative Opioid Use | postoperative day 4 | 0 milligrams morphine equivalents |
| Superior Hypogastric Plexus Block | Postoperative Opioid Use | postoperative day 1 | 2.5 milligrams morphine equivalents |
| Superior Hypogastric Plexus Block | Postoperative Opioid Use | postoperative day 5 | 0 milligrams morphine equivalents |
| Superior Hypogastric Plexus Block | Postoperative Opioid Use | postoperative day 3 | 0 milligrams morphine equivalents |
| Superior Hypogastric Plexus Block | Postoperative Opioid Use | postoperative day 6 | 0 milligrams morphine equivalents |
| Superior Hypogastric Plexus Block | Postoperative Opioid Use | postoperative day 0 | 5 milligrams morphine equivalents |
| No Block | Postoperative Opioid Use | postoperative day 6 | 0 milligrams morphine equivalents |
| No Block | Postoperative Opioid Use | postoperative day 0 | 10.2 milligrams morphine equivalents |
| No Block | Postoperative Opioid Use | postoperative day 1 | 5 milligrams morphine equivalents |
| No Block | Postoperative Opioid Use | postoperative day 2 | 2.5 milligrams morphine equivalents |
| No Block | Postoperative Opioid Use | postoperative day 3 | 3.5 milligrams morphine equivalents |
| No Block | Postoperative Opioid Use | postoperative day 4 | 0 milligrams morphine equivalents |
| No Block | Postoperative Opioid Use | postoperative day 5 | 0 milligrams morphine equivalents |
Secondary
Postoperative Pain Scores
Patients will be asked to complete a daily diary for one week following the procedure, which details their pain level using VAS pain scores from the Brief Pain Inventory (BPI). Pain is reported on a scale of 1 to 10, and a higher score indicates greater pain intensity.
Time frame: Discharge to 1 week after surgery, assessed up to 1 week after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Superior Hypogastric Plexus Block | Postoperative Pain Scores | postoperative day 2 | 5.5 score on a scale |
| Superior Hypogastric Plexus Block | Postoperative Pain Scores | postoperative day 4 | 4 score on a scale |
| Superior Hypogastric Plexus Block | Postoperative Pain Scores | postoperative day 1 | 6.3 score on a scale |
| Superior Hypogastric Plexus Block | Postoperative Pain Scores | postoperative day 5 | 3 score on a scale |
| Superior Hypogastric Plexus Block | Postoperative Pain Scores | postoperative day 3 | 4.1 score on a scale |
| Superior Hypogastric Plexus Block | Postoperative Pain Scores | postoperative day 6 | 2.8 score on a scale |
| Superior Hypogastric Plexus Block | Postoperative Pain Scores | postoperative day 0 | 5 score on a scale |
| No Block | Postoperative Pain Scores | postoperative day 6 | 2.8 score on a scale |
| No Block | Postoperative Pain Scores | postoperative day 0 | 6 score on a scale |
| No Block | Postoperative Pain Scores | postoperative day 1 | 5.6 score on a scale |
| No Block | Postoperative Pain Scores | postoperative day 2 | 5 score on a scale |
| No Block | Postoperative Pain Scores | postoperative day 3 | 4 score on a scale |
| No Block | Postoperative Pain Scores | postoperative day 4 | 4 score on a scale |
| No Block | Postoperative Pain Scores | postoperative day 5 | 3.5 score on a scale |