Post-cesarean Analgesia With Epidural Morphine Following Epidural 2-chloroprocaine

• 2% lidocaine with 1:200,000 epinephrine and epidural morphine (Drug): Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
• 3% 2-chloroprocaine and epidural morphine (Drug): Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.

Primary outcomes

• Total Amount of Opioid Used [24 hours after epidural morphine administration]

Secondary outcomes

• Total Amount of Opioid Used [12 hours after epidural morphine administration]
• Total Amount of Opioid Used [8 hours after epidural morphine administration]
• Total Amount of Opioid Used [4 hours after epidural morphine administration]
• Pain as Measured by a 11 Point Verbal Scale [4,8, 12 and 24 hours after epidural morphine administration]: scale ranges form 0-10, higher number indicating more pain
• Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale [4,8, 12 and 24 hours after epidural morphine administration]: scale ranges from non,mild and moderate-severe
• Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale [4,8, 12 and 24 hours after epidural morphine administration]: scale ranges from non,mild and moderate-severe
• Time Until First Opioid Request [Up to 48 hours after epidural morphine administration]

Sex: Female, ages: 18 Years to 50 Years

Inclusion Criteria:

* pregnant patients
* live singleton pregnancy

Exclusion Criteria:

* BMI >40
* obstructive sleep apnea
* drug abuse
* chronic pain
* chronic opioid use
* nonfunctioning epidural

Participant flow

Outcome results

• Total Amount of Opioid Used (Primary), Median, milligrams: 2 Percent Lidocaine With Epinephrine and Epidural Morphine 15 (6.3 to 22.5); 3 Percent 2-Chloroprocaine and Epidural Morphine 0 (0 to 15.6)
• Total Amount of Opioid Used (Secondary), Median, hours: 2 Percent Lidocaine With Epinephrine and Epidural Morphine 0 (0 to 7.5); 3 Percent 2-Chloroprocaine and Epidural Morphine 0 (0 to 10)
• Total Amount of Opioid Used (Secondary), Median, hours: 2 Percent Lidocaine With Epinephrine and Epidural Morphine 0 (0 to 7.5); 3 Percent 2-Chloroprocaine and Epidural Morphine 0 (0 to 10)
• Total Amount of Opioid Used (Secondary), Median, hours: 2 Percent Lidocaine With Epinephrine and Epidural Morphine 0 (0 to 0); 3 Percent 2-Chloroprocaine and Epidural Morphine 0 (0 to 8.1)
• Pain as Measured by a 11 Point Verbal Scale (Secondary), Median, score on a scale: 2 Percent Lidocaine With Epinephrine and Epidural Morphine 0 (0 to 1); 3 Percent 2-Chloroprocaine and Epidural Morphine 2.5 (0 to 5)
• Number of Participants Who Had Mild, Moderate or Severe Nausea as Measured by a 3 Point Scale (Secondary), Count of participants, Participants: 2 Percent Lidocaine With Epinephrine and Epidural Morphine 3; 3 Percent 2-Chloroprocaine and Epidural Morphine 1
• Number of Participants Who Had Mild, Moderate or Severe Pruritis as Measured by a 3 Point Scale (Secondary), Count of participants, Participants: 2 Percent Lidocaine With Epinephrine and Epidural Morphine 7; 3 Percent 2-Chloroprocaine and Epidural Morphine 3
• Time Until First Opioid Request (Secondary), Median, hours: 2 Percent Lidocaine With Epinephrine and Epidural Morphine 14.8 (7.9 to 22.7); 3 Percent 2-Chloroprocaine and Epidural Morphine 24.7 (2.7 to 36.6)

Adverse events

Time frame: 24 hours

Other adverse events by term

Limitations and caveats: No prior studies investigating the technique studied in order to calculate study size; wide interindividual differences in pain; physician administering epidural medications not blinded; originally intended to recruit 80, but due to recruitment challenges decided to modify recruitment goal to about 40 and classify this as an exploratory study

• Results publication: Lee LO, Ramirez-Chapman AL, White DL, Zhang X, Lu M, Suresh MS. Postcesarean Analgesia With Epidural Morphine After Epidural 2-Chloroprocaine: A Randomized Noninferiority Trial. Anesth Analg. 2023 Jan 1;136(1):86-93. doi: 10.1213/ANE.0000000000006109. Epub 2022 Jun 3. PMID 36534717

• Study Protocol and Statistical Analysis Plan (PDF, 2020-05-04)

• Linden Lee, MD, Principal investigator, The University of Texas Health Science Center, Houston