Surgery
Conditions
Brief summary
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.
Detailed description
All laparoscopic colorectal cases were scheduled by colorectal surgeons at IU Health University or Methodist Hospital and were identified using medical records. The subjects were contacted face-to-face prior to surgery. They were informed about the study and questions were answered. The potential subjects were given a copy of the informed consent form and authorization form. The subjects were contacted face-to-face in Pre-Operative Care Unit on the day of surgery and if they decided to participate, written consent was taken. In the Intrathecal group, intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 18-75 years of age and duramorph 150 mcg with 7.5mg of hyperbaric bupivacaine was given for a patient 76- 80 years of age. In the ESP group, a patient was given a bilateral ESP block at thoracic vertebrae level 10 (T10). This was placed under ultrasound using 30 ml of 0.25% bupivacaine and 4 mg of Decadron. Randomization will be performed using Research Randomizer. The primary investigator informed the person doing the regional techniques as to what group the patients were randomized to. Neither the patients and the research staff doing assessments will be blinded to the randomization.
Interventions
DRUGIT Injection
an intrathecal (IT) injection in the back in which a small dose duramorph and bupivacaine will be placed into the spinal fluid
DRUGESP Block
an erector spinae plane (ESP) block in which bupivacaine and decadron are injected near the nerves under a muscle in the back
Sponsors
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 Hour Cumulated Oral Morphine Equivalent (OME) | 24 hours after surgery | 24 hour cumulated oral morphine consumption (OME) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oral Morphine Equivalents (OME) | 1 hour after surgery | Oral Morphine Equivalents consumed |
| Visual Analog Scale Pain Scores | 1 hour after surgery | pain scores using the Visual Analog Scale (0-10 with 0 being no pain and 10 being the worst pain) |
| First Ambulation | Duration of hospital stay up to 72 hours | Time to patient first ambulation |
| First Flatus | Duration of hospital stay up to 72 hours | Time to first flatus |
| Oral Liquid | Duration of hospital stay up to 72 hours | Time to first oral liquid intake |
| Oral Food | Duration of hospital stay up to 72 hours | Time to first oral food intake |
| Hospital Length of Stay | Duration of hospital stay up to 7 days | Amount of time each subject spends in the hospital before discharge |
| Patient's Satisfaction Scores | 24 hours after surgery | Assess patient's satisfaction with care (1-10 with 1 being the least satisfied and 10 being the most satisfied) |
| Number of Participants With Side Effects | Duration of hospital stay up to 72 hours | Incidence of urinary retention, ileus, spinal headache, pruritis, respiratory depression, injection site infection, nerve damage, hematoma, pneumothorax, lower extremity weakness. |
| Nausea | Duration of hospital stay up to 72 hours | point in time of which had nausea |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy McCutchan, MD
Indiana University School of Medicine
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 37 Participants |
| Age, Categorical Between 18 and 65 years | 70 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | 0 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 61 Participants |
| Sex: Female, Male Male | 22 Participants |
| weight | 80 kg STANDARD_DEVIATION 18 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 51 |
| other Total, other adverse events | 7 / 56 | 2 / 51 |
| serious Total, serious adverse events | 0 / 56 | 0 / 51 |
Outcome results
None listed