Anesthesia, Spinal, Decrease Discharge Time Status Post Hemorrhoidectomy, Return of Motor and Sensory Blockade
Conditions
Keywords
Spinal anesthesia, Pain, Chloroprocaine
Brief summary
The use of 1% Chloroprocaine (PF) spinal anesthesia will reduce the recovery times and discharge time of patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine spinal. The primary objective is to compare the recovery times (return of motor and sensory function) and discharge time (voiding time) between 2-Chloroprocaine and 0.75% bupivacaine spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning patients to either 2-Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group.
Detailed description
The use of 1% Chloroprocaine (PF) spinal anesthesia will reduce the recovery times and discharge time of patients undergoing hemorrhoidectomies as compared to 0.75% bupivacaine spinal. The primary objective is to compare the recovery times (return of motor and sensory function) and discharge time (voiding time) between 1% Chloroprocaine and 0.75% bupivacaine spinal anesthesia for hemorrhoidectomies. This is a randomized, prospective study assigning patients to either 1% Chloroprocaine (PF) or 0.75% bupivacaine spinal anesthesia group. Consents for participation in the study will be obtained during the patients' preoperative anesthesia evaluation. There will be no change in the primary anesthetic technique (spinal anesthesia), since these patients routinely get spinal anesthesia for hemorrhoidectomies, however there would be a change in type of local anesthetic administration. On the day of surgery, consented patients will be randomized to one of the two groups. Both the patients and the researcher who recruited the patients and collected the data will be blinded. (Research assistant will hand an enclosed envelop to the anesthesiologists performing the spinal anesthesia with the name of local anesthetic to use) Postoperatively, the PACU nurse will be ask to document return of motor and sensory function in addition to voiding time. At the time of voiding, the nurse will be asked to inform an anesthesiologist (not involved in the case) for a postoperative evaluation and a discharge note. However, if the patient cannot void once there are able to ambulate, then they stay in PACU until they are the last patient in the unit. If still unable to void, the surgeon will be informed and an ultrasound bladder scan will be used to determine the volume of urine and the patient will be straight cath. The patient will be sent home and informed if he or she cannot void by the next day, then they should call the surgeon's office to notify them and go to the emergency room. For postoperative data collection, the routine 24hr postoperative phone calls in which nurses make to patients will be utilize, however two additional questions will be asked, 1. Presence of nerve pain in the buttocks and thighs shooting down their legs unilaterally or bilaterally, 2. Inability to void, pass flatus or defecate. If any of the symptoms are present, then the nurse will inform an anesthesiologist (not involved in the case) whom will give the patient a call and advise them on treatment protocol. The research assistant will then be informed by the anesthesiologist who made the phone call.
Interventions
DRUG1% chloroprocaine
In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
Bupivacaine is used on label
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The patients, the researcher who recruited the patients and collected the data, nurse anesthetists, discharge anesthesiologist, and the Post Anesthesia Care Unit (PACU) nurse were all blinded to the patient treatment allocations. The operating room anesthesiologist (separate from the discharge anesthesiologist) was unblinded after receiving an enclosed envelope with the name of the spinal local anesthetic to perform the neuraxial anesthesia intraoperatively.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient undergoing anorectal procedures * Age 18 and above * American Society of Anesthesiologist Physical Status (ASA), I-III
Exclusion criteria
* Patient refusal * Inability to understand and sign informed consent * Allergic reaction to bupivacaine or other local anesthetics * Coagulopathy (INR \>= 1.5) * Use of anticoagulant drugs (Plavix, Coumadin) * Thrombocytopenia (Platelets \< 100,000) * Infection at the site * Increased intracranial pressure * Unstable spine, Spine abnormalities * History of atypical cholinesterase (CP is metabolized by cholinesterase) * Diagnosis of any disorders (i.e., benign prostatic hyperplasia, cystitis, vulvovaginitis) that would delay voiding * Anticipated procedure time longer than 60 minutes
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery Time | On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours | For this study Recovery time was defined as the time (in minutes) to return of both motor and sensory function, postoperatively. The return of motor function was tested by demonstrating mobility in both lower extremities including hips, knees, and lower legs using the Bromage scale. The return of sensory function was assessed using light touch and/or pinprick techniques on the dermatomes corresponding with the T8-S2 spinal cord segments. The duration in minutes when both sensory and motor function were re-established was documented and results were summarized by study arm using basic descriptive statistics. In this study it is hypothesized that use of 1% Chloroprocaine spinal anesthesia will reduce recovery times of patients undergoing anorectal procedures as compared to 0.75% bupivacaine spinal. |
| Discharge Time | On post-operative day 1 (POD1), up to 24 hours | For this study discharge time is defined as the time (in minutes) when the patient is fit to discharge from the Postoperative Care Unit (PACU). At the institution where this study took place fit to discharge was defined as the ability to void and the ability to ambulate unassisted for at least 10 feet. The duration of time when a patient was able to do both was documented. Results were summarized by study arm using basic descriptive statistics. It is hypothesized that the use of 1% Chloroprocaine spinal anesthesia will result in a clinically significant 30% reduction in discharge times of patients as compared to 0.75% bupivacaine spinal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evidence of Hypotension | On day of procedure, 0-5 minutes following administration of spinal anesthesia | Evidence of hypotension will be documented if systolic blood pressure (SBP) drops more than 20mmHg from baseline following spinal anesthesia. Hypotension is a common side effect of spinal anesthesia (SA). The number of participants with evidence of hypotension will be summarized by study arm. |
| Evidence of Transient Neurological Symptoms (TNS) | On post-op day 2, approximately 24 hours post operation | The number of participants demonstrating TNS approximately 24 hours following the procedure will be assessed. TNS will be defined as back pain or dysesthesia that radiated to the buttocks, thighs, hips, or calves and began within the first 24 hours after surgery. Localized pain or tenderness at the injection site or lower back without radiation will not be considered TNS. TNS is clinically important as it causes patient pain and discomfort and, in severe cases, may delay discharge or cause readmission. Symptoms will be summarized and reported by study arm. |
Countries
United States
Participant flow
Recruitment details
Between September 2019 and February 2023, a total of 110 eligible patients were randomized and 55 were assigned to each treatment group, 1% Chloroprocaine or 0.75% Bupivacaine. Study was paused from March 2020 to September 2020 due to the pandemic and was also paused December 2020 because the surgery center was closed and the pharmacy was unable to obtain the necessary medications from the manufacturer.
Participants by arm
| Arm | Count |
|---|---|
| 1% Chloroprocaine (PF) 1% Chloroprocaine is an ester-linked local anesthetic with the shortest duration of action of all local anesthetics.
1% chloroprocaine: In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use. | 54 |
| 0.75% Bupivacaine 0.75% bupivacaine is a amino-amide anesthetic local anesthetic. It is hyperbaric in nature due to addition of dextrose.
0.75% bupivacaine: Bupivacaine is used on label | 51 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inability to place a spinal anesthesia due to the patients' anatomy | 1 | 4 |
Baseline characteristics
| Characteristic | Total | 0.75% Bupivacaine | 1% Chloroprocaine (PF) |
|---|---|---|---|
| Age, Continuous | 49.3 years | 48.0 years | 50.5 years |
| American Society of Anesthesiologists Physical Status (ASA-PS) Classification Class I | 4 Participants | 4 Participants | 0 Participants |
| American Society of Anesthesiologists Physical Status (ASA-PS) Classification Class II | 77 Participants | 37 Participants | 40 Participants |
| American Society of Anesthesiologists Physical Status (ASA-PS) Classification Class III | 24 Participants | 10 Participants | 14 Participants |
| Body Mass Index (BMI) | 28.6 kg/m^2 | 28.1 kg/m^2 | 29.1 kg/m^2 |
| Race and Ethnicity Not Collected | 0 Participants | — | — |
| Region of Enrollment United States | 105 participants | 51 participants | 54 participants |
| Sex: Female, Male Female | 40 Participants | 21 Participants | 19 Participants |
| Sex: Female, Male Male | 65 Participants | 30 Participants | 35 Participants |
| Surgical Procedure Ablation | 46 Participants | 22 Participants | 24 Participants |
| Surgical Procedure Anal Fissurectomy | 13 Participants | 5 Participants | 8 Participants |
| Surgical Procedure Debridement | 14 Participants | 8 Participants | 6 Participants |
| Surgical Procedure Exam Under Anesthesia | 11 Participants | 3 Participants | 8 Participants |
| Surgical Procedure Hemorrhoidectomy | 19 Participants | 12 Participants | 7 Participants |
| Surgical Procedure Other | 2 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 54 | 0 / 51 |
| other Total, other adverse events | 0 / 54 | 0 / 51 |
| serious Total, serious adverse events | 0 / 54 | 0 / 51 |
Outcome results
Primary
Discharge Time
For this study discharge time is defined as the time (in minutes) when the patient is fit to discharge from the Postoperative Care Unit (PACU). At the institution where this study took place fit to discharge was defined as the ability to void and the ability to ambulate unassisted for at least 10 feet. The duration of time when a patient was able to do both was documented. Results were summarized by study arm using basic descriptive statistics. It is hypothesized that the use of 1% Chloroprocaine spinal anesthesia will result in a clinically significant 30% reduction in discharge times of patients as compared to 0.75% bupivacaine spinal.
Time frame: On post-operative day 1 (POD1), up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Chloroprocaine (PF) | Discharge Time | 191.4 minutes | Standard Error 6.6 |
| 0.75% Bupivacaine | Discharge Time | 230.9 minutes | Standard Error 9.4 |
Primary
Recovery Time
For this study Recovery time was defined as the time (in minutes) to return of both motor and sensory function, postoperatively. The return of motor function was tested by demonstrating mobility in both lower extremities including hips, knees, and lower legs using the Bromage scale. The return of sensory function was assessed using light touch and/or pinprick techniques on the dermatomes corresponding with the T8-S2 spinal cord segments. The duration in minutes when both sensory and motor function were re-established was documented and results were summarized by study arm using basic descriptive statistics. In this study it is hypothesized that use of 1% Chloroprocaine spinal anesthesia will reduce recovery times of patients undergoing anorectal procedures as compared to 0.75% bupivacaine spinal.
Time frame: On post-operative day 1 (POD1), approximately every 15 minutes up to 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 1% Chloroprocaine (PF) | Recovery Time | 134.1 minutes | Standard Error 8.6 |
| 0.75% Bupivacaine | Recovery Time | 161.9 minutes | Standard Error 10.3 |
Secondary
Evidence of Hypotension
Evidence of hypotension will be documented if systolic blood pressure (SBP) drops more than 20mmHg from baseline following spinal anesthesia. Hypotension is a common side effect of spinal anesthesia (SA). The number of participants with evidence of hypotension will be summarized by study arm.
Time frame: On day of procedure, 0-5 minutes following administration of spinal anesthesia
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% Chloroprocaine (PF) | Evidence of Hypotension | 0 Participants |
| 0.75% Bupivacaine | Evidence of Hypotension | 0 Participants |
Secondary
Evidence of Transient Neurological Symptoms (TNS)
The number of participants demonstrating TNS approximately 24 hours following the procedure will be assessed. TNS will be defined as back pain or dysesthesia that radiated to the buttocks, thighs, hips, or calves and began within the first 24 hours after surgery. Localized pain or tenderness at the injection site or lower back without radiation will not be considered TNS. TNS is clinically important as it causes patient pain and discomfort and, in severe cases, may delay discharge or cause readmission. Symptoms will be summarized and reported by study arm.
Time frame: On post-op day 2, approximately 24 hours post operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 1% Chloroprocaine (PF) | Evidence of Transient Neurological Symptoms (TNS) | 0 Participants |
| 0.75% Bupivacaine | Evidence of Transient Neurological Symptoms (TNS) | 0 Participants |