Pain, Postoperative
Conditions
Keywords
Local, Anesthesia, Pain, Laparoscopic hysterectomy, Trocar site, Port site
Brief summary
The primary objective of this study is to assess if injection of local anesthetic to the laparoscopic trocar sites after a hysterectomy will make a difference in a patient's pain after surgery.
Detailed description
The growing interest in minimally invasive gynecologic surgeries have increased the number of patients undergoing laparoscopic hysterectomies. Although many patients are being discharged home the same day of surgery, majority of patients complain of immediate postoperative pain after a laparoscopic hysterectomy. Since postoperative pain is usually transient and improves over a short period of time, infiltration of local anesthetic to trocar insertion sites might alleviate the patient's discomfort during the recovery period. Immediate post-operative pain relief further facilitates early discharge and faster patient recovery. Published data regarding the effects of preemptive port site local anesthesia in gynecologic operative laparoscopy have been limited and controversial. Visceral pain control through afferent nerve block could minimize pain perception especially during the first postoperative hours. This study aims to assess the influence of infiltration of local anesthetic to trocar insertion sites after laparoscopic hysterectomy on postoperative pain.
Interventions
DRUGBupivacaine
Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are scheduled for a laparoscopic hysterectomy for benign indications at the Department of Obstetrics & Gynecology's Division of Minimally Invasive Surgery at Milton S. Hershey Medical Center will be included.
Exclusion criteria
* Patients who are scheduled for a hysterectomy through the vaginal or abdominal approach will be excluded. Patients with preoperative indications of endometriosis or chronic pelvic pain will also be excluded since these patients could potentially have higher thresholds of pain.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Score | 6 hours | Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move. |
| Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS) | 4 hours | Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgical Complications | From date of randomization up to 12 months | Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation. |
| Operating Time | start to end of patient's surgery | Operating time measured in minutes |
| Histopathologic Diagnosis | Histopathologic diagnosis will be measured on the day of surgery after completing the procedure. | Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other. |
| Length of Hospital Stay >= 24 Hours | from time surgery completed to time patient discharged | Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours. |
| Estimated Blood Loss > 200 mL | day of surgery after procedure completion | Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as \>200 mL vs. \<= 200 mL. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Primary Surgical Finding | Surgical findings will be measured on the day of surgery after completing the procedure. | The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other. |
Countries
United States
Participant flow
Recruitment details
Patients undergoing laparoscopic surgery at Penn State Milton S. Hershey Medical Center were recruited between 3/13 and 6/13. Allocated to CPP or no CPP based on usual clinical definitions.
Pre-assignment details
Patients in each group (Chronic Pelvic Pain and No Chronic Pelvic Pain) were randomized to receive either a bupivacaine block at each trocar site or no block. Standardization of amount of local block received was based on trocar size of 5mm or less vs. 8mm and or greater.
Participants by arm
| Arm | Count |
|---|---|
| No Treatment The No Treatment group includes patients undergoing laparoscopic hysterectomy without local infiltration of bupivacaine. | 67 |
| Bupivacaine The Bupivacaine Arm includes all patients who will receive bupivacaine injection on their trocar sites after the laparoscopic hysterectomy is completed. Bupivacaine (0.25%) will be injected through the closed incisions ensuring subcutaneous tissue, fascia, muscle and pre-peritoneal space of the trocar incision sites are infiltrated. All incisions 8 mm and greater are injected with 10 cc while all incisions 5 mm or less are infiltrated with 5 cc.
Bupivacaine: Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case. | 68 |
| Total | 135 |
Baseline characteristics
| Characteristic | No Treatment | Bupivacaine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 67 Participants | 68 Participants | 135 Participants |
| Age, Continuous | 38.3 years STANDARD_DEVIATION 8.4 | 38.6 years STANDARD_DEVIATION 10.5 | 38.5 years STANDARD_DEVIATION 9.5 |
| Chronic Pelvic Pain | 36 participants | 35 participants | 71 participants |
| Parity | 67 Participants | 68 Participants | 135 Participants |
| Region of Enrollment United States | 67 participants | 68 participants | 135 participants |
| Sex: Female, Male Female | 67 Participants | 68 Participants | 135 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 | — / — | — / — |
| other Total, other adverse events | 0 / 67 | 0 / 68 |
| serious Total, serious adverse events | 0 / 67 | 0 / 68 |
Outcome results
Primary
Postoperative Pain Score
Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 6 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move.
Time frame: 6 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Postoperative Pain Score | 4.7 units on a scale | Standard Deviation 2.3 |
| Bupivacaine | Postoperative Pain Score | 4.3 units on a scale | Standard Deviation 2.1 |
Primary
Postoperative Pain Score
Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 24 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Postoperative Pain Score | 3.5 units on a scale | Standard Deviation 2.4 |
| Bupivacaine | Postoperative Pain Score | 4.0 units on a scale | Standard Deviation 1.8 |
Primary
Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS)
Postoperative pain is measured on day of surgery after trocar incisions are closed and injected with local anesthetic. Postoperative pain is evaluated with the Numerical Rating Scale (NRS) at 4 hrs after the surgery. The Numerical Rating Scale is a scale from 0 to 10 that measures pain severity, where 0 equates to no pain and 10 equates to unable to move.
Time frame: 4 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS) | 4.1 units on a scale | Standard Deviation 2.4 |
| Bupivacaine | Postoperative Pain Score Evaluated by Numerical Rating Scale (NRS) | 3.4 units on a scale | Standard Deviation 2.6 |
Secondary
Estimated Blood Loss > 200 mL
Estimated blood loss will be measured in (mL) on the day of surgery after completing the procedure. Blood loss will be categorized as \>200 mL vs. \<= 200 mL.
Time frame: day of surgery after procedure completion
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Treatment | Estimated Blood Loss > 200 mL | 2 Participants |
| Bupivacaine | Estimated Blood Loss > 200 mL | 2 Participants |
Secondary
Histopathologic Diagnosis
Histopathologic diagnosis describes the findings seen on tissue pathology and microscopy and is defined as one of the following: endometriosis, leiomyoma, adenomyosis, or other.
Time frame: Histopathologic diagnosis will be measured on the day of surgery after completing the procedure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Treatment | Histopathologic Diagnosis | Endometriosis | 26 Participants |
| No Treatment | Histopathologic Diagnosis | Leiomyoma | 10 Participants |
| No Treatment | Histopathologic Diagnosis | Adenomyosis | 5 Participants |
| No Treatment | Histopathologic Diagnosis | Other | 26 Participants |
| Bupivacaine | Histopathologic Diagnosis | Other | 31 Participants |
| Bupivacaine | Histopathologic Diagnosis | Endometriosis | 21 Participants |
| Bupivacaine | Histopathologic Diagnosis | Adenomyosis | 3 Participants |
| Bupivacaine | Histopathologic Diagnosis | Leiomyoma | 12 Participants |
Secondary
Length of Hospital Stay >= 24 Hours
Length of hospital stay will be measured on the day of surgery after completing the procedure to when the patient is discharged from the hospital. Length of stay will be categorized as less than 24 hours vs. greater than or equal to 24 hours.
Time frame: from time surgery completed to time patient discharged
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Treatment | Length of Hospital Stay >= 24 Hours | 36 Participants |
| Bupivacaine | Length of Hospital Stay >= 24 Hours | 30 Participants |
Secondary
Operating Time
Operating time measured in minutes
Time frame: start to end of patient's surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| No Treatment | Operating Time | 73.3 minutes | Standard Deviation 33.9 |
| Bupivacaine | Operating Time | 63.8 minutes | Standard Deviation 24.5 |
Secondary
Surgical Complications
Intraoperative complications include injury to bowel, bladder, blood vessels, nerves and hemorrhage. Perioperative complications include urinary tract infections, urinary retention, ileus, myocardial infarction, atrial fibrillation, pulmonary edema, atelectasis, pneumonia, renal and cerebrovascular morbidity, thromboembolic complications (DVT and PE). Postoperative complications include pulmonary, renal, and cerebrovascular morbidity, wound and vaginal vault complications (infection, separation, and dehiscence), septicemia, thromboembolic events, and re-operation.
Time frame: From date of randomization up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| No Treatment | Surgical Complications | 0 Participants |
| Bupivacaine | Surgical Complications | 0 Participants |
Other Pre-specified
Primary Surgical Finding
The primary intra-operative finding found during surgery, defined as one of the following: endometriosis, pelvic adhesive disease, leiomyoma, or other.
Time frame: Surgical findings will be measured on the day of surgery after completing the procedure.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| No Treatment | Primary Surgical Finding | Endometriosis | 37 Participants |
| No Treatment | Primary Surgical Finding | Pelvic adhesive disease | 12 Participants |
| No Treatment | Primary Surgical Finding | Leiomyoma | 6 Participants |
| No Treatment | Primary Surgical Finding | Other | 12 Participants |
| Bupivacaine | Primary Surgical Finding | Other | 12 Participants |
| Bupivacaine | Primary Surgical Finding | Endometriosis | 41 Participants |
| Bupivacaine | Primary Surgical Finding | Leiomyoma | 9 Participants |
| Bupivacaine | Primary Surgical Finding | Pelvic adhesive disease | 5 Participants |