ESP Block VS Intrathecal Opioid After Laparoscopic Colorectal Surgery

Study Overview
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Brief Summary
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This study is being done to compare 2 types of pain control methods and determine which is more effective postoperatively for laparoscopic colorectal surgery. Group 1 will receive an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid. Group 2 will receive an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back.

Official Title
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Randomized Prospective Study Comparison of Erector Spinae Plane Block and Intrathecal Opioid for Postoperative Analgesia After Laparoscopic Colorectal Surgery in an Enhanced Recovery Setting

Conditions
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Surgery

Intervention / Treatment
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* Drug: IT Injection
* Drug: ESP Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing an elective laparoscopic colorectal procedure at Indiana University Hospital or Methodist Hospital ASA Class 1, 2, 3 (American Society of Anesthesiologists physical status classification system) Age 18 to 80 years (male or female) BMI < 40kg/m2 Desires regional anesthesia for postoperative pain control Exclusion Criteria: Any contraindication for neuraxial analgesia or ESP block procedure Contraindications for neuraxial analgesia include: Elevated intracranial pressure (except in cases of pseudo-tumor cerebri), infection at the site of injection, lack of consent from the patient, patient refusal, true allergy to any drug used in the spine, and uncorrected hypovolemia. Contraindications for ESP block procedure include: Infection at the site of injection, patient refusal, true allergy to any of the drugs used in the block, and lack of patient consent. Any patient undergoing a laparoscopic abdominoperineal resection. Any physical, mental or medical conditions which, in the opinion of the investigators, may confound quantifying postoperative pain resulting from surgery. Known true allergy to the study medications (morphine, bupivacaine, decadron, Tylenol, Celebrex) Takes over 30 mg of oral morphine equivalents daily Any history of substance abuse in the past 6 months End stage liver disease, end stage renal disease Body weight of < 50 kg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IT Injection<br>an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid | Drug: IT Injection<br>* an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid<br>|
| Active Comparator: ESP Block<br>an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back. | Drug: ESP Block<br>* an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulated oral morphine equivalent (OME) | morphine consumption | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid consumption | opioid consumption in OME | 1 hour after surgery | 
| opioid consumption | opioid consumption in OME | 12 hours after surgery | 
| opioid consumption | opioid consumption in OME | 24 hours after surgery | 
| opioid consumption | opioid consumption in OME | 48 hours after surgery | 
| opioid consumption | opioid consumption in OME | 72 hours after surgery | 
| Visual Analog Scale pain scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 1 hour after surgery | 
| Visual Analog Scale pain scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 12 hours after surgery | 
| Visual Analog Scale pain scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 24 hours after surgery | 
| Visual Analog Scale pain scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 48 hours after surgery | 
| Visual Analog Scale pain scores | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) | 72 hours after surgery | 
| opioid side effects | incidence of opioid side effects (nausea, pruritus, urinary retention, respiratory depression, ileus) | duration of hospital stay up to 72 hours | 
| first ambulation | time to patient first ambulation | duration of hospital stay up to 72 hours | 
| first flatus | time to first flatus | duration of hospital stay up to 72 hours | 
| oral liquid | time to first oral liquid intake | duration of hospital stay up to 72 hours | 
| oral food | time to first oral food intake | duration of hospital stay up to 72 hours | 
| hospital stay | amount of time each subject spends in the hospital before discharge | duration of hospital stay up to 7 days | 
| patient's satisfaction scores | assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied) | 24 hours after surgery | 
| patient's satisfaction scores | assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied) | 48 hours after surgery |