Thoracic Epidural Analgesia Versus Rectus Sheath Block Versus Surgeon Infiltration With Liposomal Bupivacaine or Standard Bupivacaine for Post-Operative Pain Control After Cystectomy

Indiana University

Status and phase: Completed; Phase 3

Conditions: Cystectomy

Treatments: Drug: injectable saline; Drug: bupivacaine 0.5%; Drug: Liposomal bupivacaine; Drug: bupivacaine 0.125%; Drug: epidural bupivacaine 0.05%; Drug: /hydromorphone 0.05mg/ml

Study type: Interventional

Funder types: Other

Identifiers

NCT04300231

1905006917

Details and patient eligibility

About

The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder).

Full description

The purpose of this study is to compare the difference between four different pain control methods in patients who will be having a cystectomy surgery (surgical removal of the bladder). By collecting this data, we aim to show improved postoperative pain scores, decreased opioid needs, and decreased opioid side effects (feeling sick to your stomach, feeling drowsy/sleepy, blockage/lack of movement in the intestines, inability to completely empty the bladder, unusually slow or shallow breathing).

The specific aim of this study is to compare the difference between the pain control methods in achieving the following:

1. Decreased opioid requirements
2. Improved postoperative VAS pain scores
3. Decreased opioid side effects (Nausea, sedation, ileus, respiratory depression)
4. Decreased hospital length of stay (LOS)

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing cystectomy for bladder cancer
• ASA class 1, 2, 3 or 4
• Age 18 or older, male or female
• Desires Regional anesthesia for postoperative pain control

Exclusion criteria

• Any contraindication for thoracic epidural.
• History of substance abuse in the past 6 months.
• Patients on more than 30mg morphine equivalents of opioids daily.
• Any physical, mental or medical conditions which in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery.
• Known allergy or other contraindications to the study medications (Acetaminophen, Gabapentin, Bupivacaine, Hydromorphone).
• Postoperative intubation.
• Any patient with history of neuropathic bowel or bladder dysfunction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 4 patient groups

Thoracic epidural

Active Comparator group

Description:

1. Thoracic epidural- epidural bupivacaine 0.05%/hydromorphone 0.05mg/ml mix will be given throughout the duration of their epidural analgesia.

Treatment:

Drug: /hydromorphone 0.05mg/ml

Drug: epidural bupivacaine 0.05%

Rectus Sheath Block

Active Comparator group

Description:

2. Rectus Sheath Block - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected into 4 locations below the rectus abdominis muscle.

Treatment:

Drug: bupivacaine 0.125%

Drug: Liposomal bupivacaine

Drug: injectable saline

Surgeon Infiltration with Liposomal Bupivacaine (LB)

Active Comparator group

Description:

3. Surgeon infiltration with Liposomal Bupivacaine (LB) - 20 mL of Exparel® diluted with 40 mL of 0.125% bupivacaine and 40 ml of injectable saline for a total of 100 mL. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery, prior to abdominal wall closure.

Treatment:

Drug: bupivacaine 0.125%

Drug: Liposomal bupivacaine

Drug: injectable saline

Surgeon Infiltration

Active Comparator group

Description:

4. Surgeon infiltration with Standard Bupivacaine (SB) - 60ml of 0.25% bupivacaine will be diluted with 40ml of saline for a total of 100ml. The 100 mL will be injected throughout the incision site by the surgeon at the end of surgery.

Treatment:

Drug: bupivacaine 0.5%

Drug: injectable saline