Pain, Postoperative
Conditions
Keywords
Hysterectomy
Brief summary
Hysterectomy is the most common major gynecologic surgery performed in the US and is performed for a variety of indications including malignancy, pelvic mass, endometriosis, leiomyoma, and pelvic organ prolapse. The traditional regimen for pain control post-operatively is opioid-based however in light of the opioid epidemic, a transition to non-opioid pain medication regimens is desired by both physicians and patients alike. The goal of this study is to develop a multimodal non-opioid pain medication regimen that minimizes postoperative opioid use after robotic assisted total laparoscopic hysterectomy. Historical controls from January, 2017 to January, 2020 will be compared to our treatment arm from November, 2020 to November, 2022. Included in our treatment protocol is paracervical block and local ropivacaine at abdominal incision sites at surgical start, gabapentin and acetaminophen preoperatively and postoperatively, and celecoxib postoperatively. Opioid use will be measured 0-3 h postop and 3-24h postop (as surrogate marker of time spent recovering in the Post Anesthesia Care Unit (PACU), and during the full length of hospital stay); pain scores will additionally be measured.
Detailed description
Material and Methods: This is a prospective cohort study with historical controls. Cases of those receiving a non-opioid multimodal pain regimen will be compared to historical controls of those receiving a traditional opioid pain regimen. All patients undergoing robotic total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy, with a uterine weight ≤325 grams will be included in this study. Multimodal pain regimen will include the following: Protocol: Pre-Op: - Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op area) * Acetaminophen 1000mg PO x1 prior to surgery (in pre-op area) Intra-Op: * Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL * Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL * Will operate at \<15mmHg intra-abdominal pressure with goal of \<12mmHg * At end of procedure during closure of fascia, give 30mg ketorolac IV x 1 Post-Op: * Gabapentin 300mg PO BID for 7 days * Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN * Celecoxib 200mg PO q 12h x 7d * Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 tabs x 5mg upon discharge (90MME) * if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge * Also include standard post-op medications such as zofran, reglan, mylicon… Our primary outcome is opioid pain medication needed after surgery. Our secondary outcomes include pain scores as rated subjectively by the patient, length of stay in hours and whether the patient returns to the clinic or emergency department due to post operative pain within a 2 week period.
Interventions
600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op
Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op
Celecoxib 200mg PO q 12h x 7d post op
30mg IV once at end of hysterectomy procedure
0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL
0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total
1mg IV PRN q3h, post op, while inpatient
To be discharged home with: 12 tabs of 5mg PRN q4h
Sponsors
Study design
Intervention model description
Prospective cohort with retrospective controls
Eligibility
Inclusion criteria
* Women undergoing robotic-assisted total laparoscopic hysterectomy, with or without bilateral salpingo-oophorectomy * Uterine weight ≤325 grams
Exclusion criteria
* contraindication to any study medications (h/o gastric bypass, gastric ulcers, CKD) * current opioid prescription
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) | 0-3 hours after surgery | Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME) |
| Total Opioid Pain Medications Required Through 3-24h Post op in MME | 3-24 hours after surgery | Total opioid pain medications required through 3-24h post op in MME |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period | 0-14 days | Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period |
| Pain Scores | 3-24 hours after surgery | Subjective, Score 0-10 with 0 being no pain and 10 being severe pain |
| Estimated Blood Loss | 0-300 minutes | milliliters (mL) |
| Operative Time | 0-300 minutes | minutes |
| Length of Stay in Hours | 0- 240 hours | Length of stay in hours |
Countries
United States
Participant flow
Recruitment details
For the intervention arm, patients were recruited from November 24, 2020 to May 24, 2022. Data for the retrospective controls who underwent their hysterectomy from 11/27/2018 to 12/12/2019, was obtained via chart review. This was a prospective cohort study with retrospective controls. To allow for adjustment to this new protocol, 11 months were allocated to the institution and staff, prior to enrolling patients in the intervention arm.
Pre-assignment details
49 patients were analyzed as 18 of 28 intervention arm participants did not receive the intervention or their care required deviation from the from study protocol (e.g., no minimally invasive hysterectomy due to laparotomy, no paracervical block due to indocyanine green injection for lymph node mapping, no postoperative protocol medications due to limited resources and logistical issues). One of the 40 control participants was excluded due to uterine weight exceeding the study protocol range.
Participants by arm
| Arm | Count |
|---|---|
| Prospective Cohort Pre-Op:
* Gabapentin 600mg PO PO x 1 prior to surgery (in pre-op)
* Acetaminophen 1000mg PO x1 prior to surgery (in pre-op)
Intra-Op:
* Paracervical block with local anesthetic (0.5% ropivacaine); 10 mL bilaterally (2 point) for total of 20mL
* Local anesthetic (0.5% ropivacaine) at all laparoscopic port sites; another 10mL
* Will operate at \<15mmHg intra-abdominal pressure, with goal of \<12mmHg
* At end of procedure during closure of fascia, give 30mg ketorolac IV x 1
Post-Op:
* Gabapentin 300mg PO BID for 7 days
* Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN
* Celecoxib 200mg PO q 12h x 7d
* Dilaudid 1mg IV PRN q3h while inpatient; oxycodone 12 x 5mg upon discharge (90MME) if patient did not use any opioids postoperatively while inpatient, will not prescribe opioid medication upon discharge | 10 |
| Historical Control Traditional post-operative opioid medication regimen: Dilaudid 1mg IV PRN q3h while inpatient; Percocets 12 x 5mg/325 (90MME) upon discharge
Hydromorphone: 1mg IV PRN q3h, post op, while inpatient | 39 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 18 | 1 |
Baseline characteristics
| Characteristic | Historical Control | Total | Prospective Cohort |
|---|---|---|---|
| Age, Continuous | 44.13 years | 44.37 years | 44.60 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 39 participants | 49 participants | 10 participants |
| Sex: Female, Male Female | 39 Participants | 49 Participants | 10 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 / 10 | 0 / 39 |
| other Total, other adverse events | 0 / 10 | 0 / 39 |
| serious Total, serious adverse events | 0 / 10 | 0 / 39 |
Outcome results
Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)
Total opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)
Time frame: 0-3 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prospective Cohort | Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) | 2.00 morphine milligram equivalents (MME) |
| Historical Control | Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME) | 5.32 morphine milligram equivalents (MME) |
Total Opioid Pain Medications Required Through 3-24h Post op in MME
Total opioid pain medications required through 3-24h post op in MME
Time frame: 3-24 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prospective Cohort | Total Opioid Pain Medications Required Through 3-24h Post op in MME | .20 morphine milligram equivalents (MME) |
| Historical Control | Total Opioid Pain Medications Required Through 3-24h Post op in MME | 12.27 morphine milligram equivalents (MME) |
Estimated Blood Loss
milliliters (mL)
Time frame: 0-300 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prospective Cohort | Estimated Blood Loss | 63.50 milliliters |
| Historical Control | Estimated Blood Loss | 58.46 milliliters |
Length of Stay in Hours
Length of stay in hours
Time frame: 0- 240 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prospective Cohort | Length of Stay in Hours | 12.05 hours |
| Historical Control | Length of Stay in Hours | 35.82 hours |
Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period
Number of patients with return to the clinic, emergency department due to post operative pain within a 2 week period
Time frame: 0-14 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prospective Cohort | Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period | 1 Participants |
| Historical Control | Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period | 3 Participants |
Operative Time
minutes
Time frame: 0-300 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prospective Cohort | Operative Time | 128.80 minutes |
| Historical Control | Operative Time | 139.69 minutes |
Pain Scores
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
Time frame: 0-3 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prospective Cohort | Pain Scores | 3.82 score on a scale |
| Historical Control | Pain Scores | 5.13 score on a scale |
Pain Scores
Subjective, Score 0-10 with 0 being no pain and 10 being severe pain
Time frame: 3-24 hours after surgery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prospective Cohort | Pain Scores | 1.75 score on a scale |
| Historical Control | Pain Scores | 5.43 score on a scale |