Randomized Prospective Study Comparison of Erector Spinae Plane Block and Intrathecal Opioid for Postoperative Analgesia After Laparoscopic Colorectal Surgery in an Enhanced Recovery Setting
Phase: PHASE1
Conditions: Surgery
Sponsor: Indiana University

 
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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   
 
Dr. Amy McCutchan 
Asst. Prof., Dept. of Anesthesiology,  
Indiana University School of Medicine 
Fesler Hall 204, 1120 South drive, 
Indianapolis, IN 46202-5115 
 
 
 

 
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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   
 
Dr. Amy McCutchan 
Asst. Prof., Dept. of Anesthesiology,  
Indiana University School of Medicine 
Fesler Hall 204, 1120 South drive, 
Indianapolis, IN 46202-5115 
 
Dr. Yar Yeap 
Associate. Prof., Dept. of Anesthesiology,  
Indiana University School of Medicine 
Fesler Hall 204, 1120 South drive, 
Indianapolis, IN 46202-5115 
 
Dr. Gulraj Chawla 
Asst. Prof., Dept. of Anesthesiology,  
Indiana University School of Medicine 
Fesler Hall 204, 1120 South drive, 
Indianapolis, IN 46202-5115 
 
Dr. Greg Jenkins  
Asst. Prof., Dept. of Anesthesiology,  
Indiana University School of Medicine 
Fesler Hall 204, 1120 South drive, 
Indianapolis, IN 46202-5115 
 
Dr. Matt Warner  
Asst. Prof., Dept. of Anesthesiology,  
Indiana University School of Medicine 
Fesler Hall 204, 1120 South drive, 
Indianapolis, IN 46202-5115 
 
Dr. Tejinder Soi  
Asst. Prof., Dept. of Anesthesiology,  
Indiana University School of Medicine 
Fesler Hall 204, 1120 South drive, 
Indianapolis, IN 46202-5115 
 
Dr. Sanjay Mohanty 
Asst. Prof., Dept. of Colorectal Surgery 
EH 505, 545 Barnhill Drive 
Indianapolis, IN 46202-5115 
  
Dr. Bryan Holcomb  
Asst. Prof., Dept. of Colorectal Surgery 
EH 500, 545 Barnhill Drive 
Indianapolis, IN 46202-5115 
 
Dr. Bruce Robb 
Associate. Prof., Dept. of Colorectal Surgery 
EH 503, 545 Barnhill Drive 
Indianapolis, IN 46202-5115 
 
 
V.1 3/23/21 
 

 
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Table of Contents: 
 
Study Schema 
1.0 
Background 
2.0 
Rationale and Specific Aims 
3.0 
Inclusion/Exclusion Criteria 
4.0 
Enrollment/Randomization 
5.0 
Study Procedures 
6.0 
Reporting of Adverse Events or Unanticipated Problems Involving Risk to 
Participants or Others 
7.0 
Study Withdrawal/Discontinuation 
8.0 
Statistical Considerations 
9.0 
Privacy/Confidentiality Issues 
10.0 
Follow-up and Record Retention 
 
 

 
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1.0 
Background 
 
Enhanced recovery after surgery (ERAS) pathways aim to standardize and integrate perioperative 
care. These pathways incorporating the best available evidence-based practice targeted at 
attenuating the surgical stress response while optimizing physiologic function, with the goal of 
facilitating patient recovery [1, 2]. Things which can prevent hospital discharge after surgery are 
pain and gut dysfunction contributing to longer patient length of stay, complications and lower 
satisfaction scores. The preoperative, intraoperative and postoperative fundamental elements of 
the enhanced recovery pathway are designed to target these issues. Many of the early efforts at 
ERAS pathways targeted colorectal surgery and have been highly successful at reducing patient 
length of stay and complications [3, 4, 5, 6].  
Multimodal pain management and regional pain techniques are one of the key intraoperative 
components of the ERAS pathway contributing to its success not only in creating great patient 
analgesia, but also reducing patient opioid requirements and other complications [7].  Various 
regional techniques for postoperative pain control are being used in laparoscopic colorectal cases, 
and yet, no particular standardized technique has been elucidated to work the best for these 
surgical cases.  
Thoracic epidurals are no longer considered the standard of care in laparoscopic colorectal cases 
as they have been linked to longer hospital length of stay in these types of surgical cases [8, 9, 
10].  Intrathecal opioids are commonly used and remain one of the main vehicles to help control 
postoperative pain for these cases, but this modality can occasionally contribute to patient side 
effects such as nausea, itching, urinary retention and rarely respiratory depression [11, 12, 13, 
14]. With the advent of peripheral nerve abdominal blocks such as the transverse abdominis plane 
block (TAP), the quadratus lumborum block (QL), and the erector spinae block (ESP), we have 
seen a shift in practice towards the use of these various blocks in laparoscopic abdominal surgery 
[15, 16, 17, 18, 19].  Of these abdominal blocks, the ESP block has been demonstrated to have 
lasting analgesic effects for more than 24 hours, and studies have shown its potential to cover 
both somatic and visceral pain fibers [20, 21].  
The ESP block was first described by Forero in 2016 as an effective treatment method for 
thoracic neuropathic pain [22].  Since first described in the literature, ESP blocks have been used 
successfully in many surgical procedures due to its ease of application, safety, and positive 
outcomes regarding reduction in postoperative pain scores and analgesic requirements [23, 24, 
25, 26, 27].  Even though it is not known what abdominal wall blocks work best for a particular 
laparoscopic surgery, an increasing number of studies on the TAP and the QL peripheral nerve 
blocks have shown to not be as beneficial as thought in laparoscopic colorectal surgery for 
postoperative pain management [28, 29, 30, 31].  The ESP block, however, has shown to provide 
extensive postoperative pain benefit to patients receiving laparoscopic abdominal surgery [32, 33, 
34, 35].  In addition, this particular regional approach in the mid- thoracic area has been reported 
to have dermatomal distribution sensory loss ranging from 5-9 intercostal spaces from the point 
of injection, and the potential to reach nerves transmitting not only somatic pain, but also visceral 
pain possibly making it an optimal analgesic block for laparoscopic colorectal surgeries [36, 37].  
In this study we aim to compare the ESP block combined with standard multimodal analgesia to 
intrathecal duramorph with standard multimodal analgesia on postoperative pain in elective 
laparoscopic colorectal cases within an ERAS standardized care bundle.  In this unblinded 
prospective randomized control trial, we hypothesize that ESP block will provide a significant 

 
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reduction in patient opioid consumption when compared to intrathecal opioid analgesia in the first 
24 hours in patients who undergo laparoscopic colorectal surgery in a planned ERAS protocol 
[38].  
2.0 
Rationale and Specific Aims 
 
The two pain control modalities in this study have been used as postoperative analgesia in prior 
studies. The specific aim of this study is to compare the difference between these two regional 
pain control methods in achieving the following:  
 
1. Decreased patient narcotics requirements 
2. Improved patient postoperative pain scores and patient satisfaction scores 
3. Decreased narcotic side effects (nausea, pruritis, urinary retention, respiratory depression 
and ileus).  
 
The primary endpoint of this study will be cumulated oral morphine equivalent (OME) 
consumption (mg) during the first 24 postoperative hours.  
The secondary endpoints include opioid consumption in OME and pain scores using the Visual 
Analog Scale at 1, 12, 24, 48 and 72 hours postoperatively, incidence of opioid side effects 
(nausea, pruritus, urinary retention, respiratory depression, ileus), time to patient first ambulation, 
time to first flatus, time to first oral liquid, time to first food intake, length of hospital stay, and 
patient’s satisfaction scores at 24 and 48 hours. 
3.0 
Inclusion/Exclusion Criteria 
 
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 
o 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. 
o 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.   

 
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• 
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  
 
4.0 
Enrollment/Randomization 
 
All laparoscopic colorectal cases scheduled by colorectal surgeons at IU Health University or 
Methodist Hospital will be identified using medical records. The subjects will be contacted face-
to-face prior to surgery. They will be informed about the study and all questions will be 
answered. The potential subjects will be given a copy of the informed consent form and 
authorization form. The subjects will then be contacted face-to-face in Pre-Operative Care Unit 
on the day of surgery and if participation is agreed, written consent will be taken.  
 
A total of subjects (n=126) will be randomized by a computer program into two groups (63 per 
group):  
 
1. 
Intrathecal preservative free morphine (duramorph) 200 mcg with 7.5mg of 
hyperbaric bupivacaine for patient 18-75 years of age and duramorph 150 mcg with 
7.5mg of hyperbaric bupivacaine for patients 75- 80 years of age – placed by a spinal 
needle (n=63) 
2. 
Bilateral ESP block at thoracic vertebrae level 10 (T10) – placed under ultrasound 
using 30 ml of 0.25% bupivacaine and 4 mg of Decadron (n=63)  
 
Randomization will be performed using Research Randomizer. The primary investigator will 
inform the person doing the regional techniques as to what group the patients are randomized to. 
Neither the patients and the research staff doing assessments will be blinded to the randomization.  
 
5.0 
Study Procedures 
 
Both the ESP blocks and the intrathecal procedure will be done prior to anesthesia induction. All 
procedures will be done using sterile technique with masks, hats, and sterile gloves. All ESP 
blocks will be placed by the anesthesiologist or the resident directly under the supervision of the 
attending anesthesiologist on the acute pain service as will the intrathecal duramorph placement. 
Standardized postoperative multi- modal analgesia will be administered to all study patients 
according to the institutional ERAS protocol.   
 
All patients will receive 1 gm of Tylenol and 200mg of Celebrex preoperatively. Patient will be 
randomized into one of two arms, those receiving the ESP block and those receiving the 
intrathecal duramorph. 
The ESP block will be placed bilaterally prior to anesthesia induction.  After skin sterilization, an 
ultrasound probe will be placed on the 10th thoracic vertebrae (T10) after counting down from the 
spine of the seventh cervical vertebrae. Dependent on the patient’s body habitus, a high frequency 
linear or curvilinear ultrasound transducer probe will be used. The probe will be placed 2-3 cm 

 
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lateral to the T10 spinous process using a sagittal approach. After identification of the transverse 
process (TP) and the erector spinae muscle, a 21gauge Stimuplex® needle will be advanced using 
an in-plane technique until the needle is between TP and the erector spinae muscle [39].  The 
correct location of the needle tip will be confirmed initially by hydro-dissection with a small 
amount of sterile saline.  After the appropriate needle tip positioning between the TP and the 
erector spinae muscle is confirmed, 30 ml of 0.25% bupivacaine mixed with 4 mg of Decadron 
will be administered at the site. This procedure will be repeated following the same steps on the 
other side of the patient’s back.  A total dose of local anesthetic bupivacaine 150mg in a volume 
of 60 ml will be used to complete the procedural block.  
Patients assigned to the (intrathecal) IT group will receive 150 mcg of duramorph with 7.5 mg of 
hyperbaric bupivacaine injection in the operating room before induction of general anesthesia, 
with the patient under conscious sedation in the sitting or lateral decubitus position.  24-G 
Pencan® pencil-point spinal needle (B. Braun Medical) or a 22- or 25-G Whitacre spinal needle 
(Medline Industries) will be inserted in the L3 – 4 or L4 – 5 spinal space via the midline 
approach.  Alternatively, the paramedian approach can be used if the midline approach is 
unfavorable. Entry into the intrathecal space will be confirmed by the presence of free-flowing 
cerebrospinal fluid. 
All patients will receive standardized endotracheal general anesthesia with Propofol or Etomidate 
for induction and paralytic per choice of the anesthesiologist. As part of the ERAS protocol, all 
patients will receive a ketamine bolus of 0.35 mg /kg IBW and then a ketamine infusion (average 
of 0.15-0.25 mg/kg/hr IBW) which is our current standard of practice. Medications for nausea 
prevention will also be given. Intraoperative opioids will be given as needed at the discretion of 
the anesthesiologist.   
All patients will be scheduled on PO acetaminophen and Celebrex per ERAS protocol until 
discharge. PO oxycodone as needed will be started once patients are tolerating diet.  PRN IV 
hydromorphone, morphine or fentanyl will be added for breakthrough pain. 
Patients in the intrathecal group will be monitored according to the institutional guidelines 
outlined in a standardized intrathecal for analgesia order set. All patients will be monitored with 
continuous pulse oximetry, end tidal CO2 monitoring, and nursing assessments.   
 
Opioid consumption at 1, 12, 24, 48, 72 hours will be recorded by a member of the research team 
from the time of arrival to the Post Anesthesia Care Unit.  Pain scores will be measured using 
Visual Analog Scale ranging from 0 (no pain) to 10 (severe pain) [40] at 1, 12, 24, 48, 72 hours.  
Incidence of nausea will be measured using a categorical scoring system (none=0; mild=1; 
moderate=2; severe=3).  Incidence of urinary retention will be determined by foley catheter 
placement or straight catheterization.  Incidence of pruritis will determined by nalbuphine or 
Benadryl use.  Incidence of respiratory depression will be determined by Narcan requirement. 
These secondary endpoints will be measured at 1 and 24 hours after arrival to the Post Anesthesia 
Care Unit.  Incidence of ileus will also be recorded if it occurs throughout the patient’s stay. 
Patients will be encouraged to ambulate on postoperative day 0 under supervision. Time to 
ambulation will be recorded along with time to flatus, time to first liquid and time to first food 
intake. The patient’s satisfactions score will be determined at 24 and 48 hours and will be defined 
as follows: very unsatisfied =0 unsatisfied =1, neutral =2, satisfied =3, very satisfied= 4.  
The length of stay will be measured by the number of days the patient is in the hospital until 
discharge from the hospital.  

 
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6.0 
Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
 
Patients will be monitored by the primary team during the postoperative period, and any adverse 
events or unanticipated problem such as lower extremity weakness, spinal headache, injection site 
infections, nerve damage, and hematoma formation or pneumothorax will be recorded and 
reported to the acute pain anesthesia resident and research team.  All adverse events will be 
promptly reported to the IRB committee using an appropriate reporting form. 
 
7.0 
Data Safety Monitoring 
 
This study will be monitored by members of the study team annually. Data quality, subject 
recruitment, outcomes and adverse event data, assessment of scientific reports and therapeutic 
development, results of related studies that impact subject safety, and privacy procedures will be 
monitored. 
 
 
8.0 
Study Withdrawal/Discontinuation 
 
The patient can withdraw from the study at any time by contacting the research team or acute 
pain anesthesia resident. In such an event, patient may still have access to all the IV and oral pain 
medications. Anesthesia acute pain team will continue to follow the patient for 24 hours. 24 hours 
after patient’s withdrawal, anesthesia acute pain team will sign off and all further pain 
management will be done by the primary team. 
 
 
9.0 
Statistical Considerations 
 
Primary outcome: Cumulated oral morphine equivalent (OME) consumption (mg) during the first 
24 postoperative hours. 
 
Primary Research Hypothesis: ESP block will provide a significant reduction in patient opioid 
consumption when compared to intrathecal opioid analgesia in the first 24 hours.  
 
Secondary outcomes: Narcotic usage at 1, 12, 24, 48, and 72 hours.  Pain scores using VAS at 1, 
12, 24, 48 hours, 72 hours.  Nausea, pruritis, urinary retention, respiratory depression at 1, 24 
hours. Incidence of ileus. Time to ambulation, time to flatus, time to first liquid and time to first 
food intake. Length of stay. Patient satisfaction score at 24 and 48 hours.  
 
Secondary Research Hypotheses: ESP block will show improved pain control and a lower 
incidence of nausea, urinary retention, pruritis, respiratory depression, and ileus compared to 
intrathecal opioid. Time to patient oral intake, ambulation and length of stay will be shorter. 
Patient satisfaction scores will also improve. 
 
Statistical analysis will be performed using a standard statistical program (SAS or SPSS). All data 
will be summarized (means, standard deviations, standard errors, and ranges for continuous 
variables; frequencies and percentages for categorical variables) by group. Demographic data will 
be compared using either t-test or Wilcoxon rank sum test as appropriate for continuous variables 

 
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and chi-square or Fisher’s exact test as appropriate for categorical variables. Either median, 25th 
percentiles, and 75th percentiles or % counts will also be reported for each group. 
The primary endpoint of cumulated oral morphine equivalent (OME) consumption (mg) 
during the first 24 postoperative hours will be compared between the two groups using the 
Wilcoxon Rank-Sum Test. Secondary endpoints of pain scores and opioid consumption at 1, 12, 
24, 48, and 72 hours postoperatively will each be analyzed using a using a Mixed effect Model 
Repeat Measurement (MMRM). These models will include a fixed effect for group, time, and 
group by time interaction along with a random intercept effect. Differences between the two 
groups at each time point for each of these three endpoints will be computed via LSMEANS. A 
Šidák correction will be employed to adjust these resulting p-values for multiple comparisons 
across time points. 
For other secondary endpoints the analyses will be as follows. The ordinal endpoints of 
nausea, and satisfaction scores will all be compared between the two groups using the Wilcoxon 
Rank-Sum Test at each time point. Incidences of urinary retention, ileus, pruritis, and respiratory 
depression will be compared between the two groups using the chi-square or Fisher’s exact test as 
appropriate. Finally, the differences between the two groups for the time to event outcomes, 
including time to ambulation, time to flatus, time to first liquid, time to first food intake and 
length of stay will each be compared using the Wilcoxon Rank-Sum Test. 
Group sample sizes were determined from a statistical power analysis. Based on previous 
studies, we’ve estimated a coefficient of variation of 1.1 for the primary outcome. From this 
estimate this study will have a power of 80% to detect a 40% decrease in cumulated opioid usage 
during the first 24 hours between the two groups with a sample size of 63 per group (50 assuming 
a 20% dropout rate), assuming a two-sided test conducted at a 5% significance level. 
 
 
10.0 
Privacy/Confidentiality Issues 
 
All study papers containing patient identifiers will be kept in each subject’s confidential study file 
accessible to only the research team.  All records will be kept in a locked room in a locked 
cabinet that only authorized staff enters.  Collected data from each enrolled participant will be 
recorded on REDCap, which is a secure web-based data collection tool. At the end of the study, 
all electronic information and paperwork containing patient identifiers will be deleted or 
shredded. 
 
 
11.0 
Follow-up and Record Retention 
 
The study will start in September or October of 2021 and will end when a sample size of 126 
subjects are achieved. The estimated time frame to enroll 126 study subjects is 30 months. After 
126 subjects have been enrolled, the study will be stopped and the data collected will be analyzed 
using statistical methods. 
 
At the end of the study, all study papers with patient identifiers will be shredded and only data 
without any patient identifiers will be retained by the research team for an indefinite time.  
  
 
 
 
 
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