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Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

Multimodal Pain Management After Robotic-Assisted Total Laparoscopic Hysterectomy

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04429022
Acronym
RA-TLH
Enrollment
68
Registered
2020-06-11
Start date
2020-11-24
Completion date
2022-05-31
Last updated
2023-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

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

DRUGGabapentin

600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op

DRUGAcetaminophen

Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op

DRUGCelecoxib

Celecoxib 200mg PO q 12h x 7d post op

DRUGKetorolac

30mg IV once at end of hysterectomy procedure

PROCEDUREParacervical block with ropivacaine

0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL

PROCEDURELocal anesthetic injection with ropivacaine at abdominal laparoscopic port sites

0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total

DRUGHydromorphone

1mg IV PRN q3h, post op, while inpatient

DRUGOxycodone

To be discharged home with: 12 tabs of 5mg PRN q4h

Sponsors

State University of New York at Buffalo
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective cohort with retrospective controls

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 90 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Total Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)0-3 hours after surgeryTotal opioid pain medications required 0-3h post op in morphine milligram equivalents (MME)
Total Opioid Pain Medications Required Through 3-24h Post op in MME3-24 hours after surgeryTotal opioid pain medications required through 3-24h post op in MME

Secondary

MeasureTime frameDescription
Number of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period0-14 daysNumber of patients with return to the clinic, emergency department due to post operative pain within a 2 week period
Pain Scores3-24 hours after surgerySubjective, Score 0-10 with 0 being no pain and 10 being severe pain
Estimated Blood Loss0-300 minutesmilliliters (mL)
Operative Time0-300 minutesminutes
Length of Stay in Hours0- 240 hoursLength 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

ArmCount
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
Total49

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation181

Baseline characteristics

CharacteristicHistorical ControlTotalProspective Cohort
Age, Continuous44.13 years44.37 years44.60 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
39 participants49 participants10 participants
Sex: Female, Male
Female
39 Participants49 Participants10 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 100 / 39
other
Total, other adverse events
0 / 100 / 39
serious
Total, serious adverse events
0 / 100 / 39

Outcome results

Primary

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

ArmMeasureValue (MEAN)
Prospective CohortTotal Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)2.00 morphine milligram equivalents (MME)
Historical ControlTotal Opioid Pain Medications Required 0-3h Post op in Morphine Milligram Equivalents (MME)5.32 morphine milligram equivalents (MME)
Primary

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

ArmMeasureValue (MEAN)
Prospective CohortTotal Opioid Pain Medications Required Through 3-24h Post op in MME.20 morphine milligram equivalents (MME)
Historical ControlTotal Opioid Pain Medications Required Through 3-24h Post op in MME12.27 morphine milligram equivalents (MME)
Secondary

Estimated Blood Loss

milliliters (mL)

Time frame: 0-300 minutes

ArmMeasureValue (MEAN)
Prospective CohortEstimated Blood Loss63.50 milliliters
Historical ControlEstimated Blood Loss58.46 milliliters
Secondary

Length of Stay in Hours

Length of stay in hours

Time frame: 0- 240 hours

ArmMeasureValue (MEAN)
Prospective CohortLength of Stay in Hours12.05 hours
Historical ControlLength of Stay in Hours35.82 hours
Secondary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Prospective CohortNumber of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period1 Participants
Historical ControlNumber of Patients With Return to the Clinic, Emergency Department Due to Post Operative Pain Within a 2 Week Period3 Participants
Secondary

Operative Time

minutes

Time frame: 0-300 minutes

ArmMeasureValue (MEAN)
Prospective CohortOperative Time128.80 minutes
Historical ControlOperative Time139.69 minutes
Secondary

Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain

Time frame: 0-3 hours after surgery

ArmMeasureValue (MEAN)
Prospective CohortPain Scores3.82 score on a scale
Historical ControlPain Scores5.13 score on a scale
Secondary

Pain Scores

Subjective, Score 0-10 with 0 being no pain and 10 being severe pain

Time frame: 3-24 hours after surgery

ArmMeasureValue (MEAN)
Prospective CohortPain Scores1.75 score on a scale
Historical ControlPain Scores5.43 score on a scale

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026