Trial Outcomes & Findings for Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies (NCT NCT04258631)

NCT ID: NCT04258631

Last Updated: 2024-10-16

Results Overview

The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. The total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy. The median total OBAS score for each group is presented.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 105 participants
• Primary outcome timeframe: Up to 24 hours after surgery
• Results posted on: 2024-10-16

Participant Flow

Participant milestones

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Overall Study STARTED	59	46
Overall Study COMPLETED	59	46
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Liposomal Bupivacaine With or Without Hydromorphone for the Improvement of Pain Control After Laparotomy in Patients With Gynecological Malignancies

Baseline characteristics by cohort

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Total n=105 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants	24 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	28 Participants n=5 Participants	22 Participants n=7 Participants	50 Participants n=5 Participants
Age, Continuous	56 years n=5 Participants	56.5 years n=7 Participants	56 years n=5 Participants
Sex: Female, Male Female	59 Participants n=5 Participants	46 Participants n=7 Participants	105 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	46 Participants n=7 Participants	101 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	55 Participants n=5 Participants	46 Participants n=7 Participants	101 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants	46 participants n=7 Participants	105 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 24 hours after surgery

The Overall Benefit of Analgesia Score (OBAS) is a multi-dimensional survey that measures a patient's benefit from postoperative pain therapy. It assesses pain intensity, opioid-related adverse events, and patient satisfaction with analgesia. Each of 7 questions are scored on a scale from 0 to 4 where 0=minimal/not at all and 4=maximum/very much. The total score is a sum of the 7 item scores with question 7 scored as 4 minus the patient reported number. Total scores range from 0 to 28 with lower scores representing greater benefit from analgesic therapy. The median total OBAS score for each group is presented.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Overall Benefit of Analgesia Score (OBAS)	4 score on a scale Interval 2.0 to 7.0	4 score on a scale Interval 3.0 to 9.0

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Various narcotic medications are standardized and reported as Morphine Milligram Equivalents (MME).

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Cumulative 24-hour Narcotic Consumption	41.4 Morphine Milligram Equivalents (MME) Standard Deviation 31.9	17.5 Morphine Milligram Equivalents (MME) Standard Deviation 25.0

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Postoperative pain is scored on a scale of 0 - 10, with the lower score showing a better outcome.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Post-operative Pain Scores	4 score on a scale Interval 2.5 to 5.0	3 score on a scale Interval 1.0 to 5.0

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Population: Analyses were based on treatment received, not randomization arm.

Amount of time from leaving surgery to the first request for pain relief.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Time to First Analgesic Request	20.1 minutes Interval 2.5 to 35.0	25.0 minutes Interval 2.5 to 38.0

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Number of patients that used IV, patient controlled analgesia after surgery.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Use of Intravenous (IV) Patient-controlled Analgesia	3 Participants	5 Participants

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Number of patients that needed IV rescue opioids after surgery.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Use of Intravenous Rescue Opioids	42 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to 1 week after surgery

Length of associated hospitalization in days.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Length of Stay	3.8 days Interval 2.9 to 4.9	3.4 days Interval 2.1 to 4.9

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Number of patients requiring additional IV fluids after surgery.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Additional Fluid Requirement After 24 Hours of Surgery	27 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Population: Data not collected

Weight difference post- and pre-surgery.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Entire hospitalization, approximately 2-5 days

All medical costs occurring during hospitalization.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Total Cost of Care	30109 dollars Interval 25077.0 to 37696.0	27776 dollars Interval 21766.0 to 37890.0

SECONDARY outcome

Timeframe: Up to 24 hours after surgery

Reported as the number participants reporting one or more adverse events on each study arm.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Incidence of Adverse Events	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Approximately 8 hours

Length of time from when the patient entered the operating room to when they left.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Operating Room Time	6.2 hours Interval 4.7 to 7.5	5.8 hours Interval 4.3 to 7.6

SECONDARY outcome

Timeframe: Approximately 8 hours

Time from first incision to surgical site closure.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Surgical Time	4.5 hours Interval 3.3 to 6.0	4.4 hours Interval 2.9 to 5.8

SECONDARY outcome

Timeframe: Whole hospitalization, approximately 2-5 days

Pharmaceutical costs associated with pain management.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Pain Management	830 dollars Interval 692.0 to 1196.0	807 dollars Interval 630.0 to 1101.0

OTHER_PRE_SPECIFIED outcome

Timeframe: At 24 hours after surgery

The Quality of Recovery (QoR-15) questionnaire is a 15-item survey that patients rate to measure the quality of their recovery after surgery. Each item in the questionnaire is graded on an 11-point numeric rating scale with total scores ranging from 15 to 150. Higher scores indicate better recovery.

Outcome measures

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 Participants Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Quality of Recovery-15 (QoR-15) Total Score	95.5 score on a scale Interval 77.0 to 105.2	104.0 score on a scale Interval 84.2 to 113.0

Adverse Events

Arm I (Laparotomy, Liposomal Bupivacaine)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Laparotomy, Liposomal Bupivacaine) n=59 participants at risk Patients undergo standard of care laparotomy and then receive liposomal bupivacaine. Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies	Arm II (Laparotomy, Liposomal Bupivacaine, Hydromorphone) n=46 participants at risk Patients undergo standard of care laparotomy and then receive liposomal bupivacaine and hydromorphone IT. Hydromorphone: Given IT Laparotomy: Undergo laparotomy Liposomal Bupivacaine: Drug Questionnaire Administration: Ancillary studies
Nervous system disorders Spinal headache	0.00% 0/59 • Up to 24 hours after surgery	2.2% 1/46 • Number of events 1 • Up to 24 hours after surgery

Other adverse events

Adverse event data not reported

Additional Information

Sean C. Dowdy, M.D.

Mayo Clinic

Phone: 507-266-0225

Email: Dowdy.Sean@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place