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Does preemptive hydromorphone and ropivacaine thoracic epidural analgesia have clinical benefits?

Comparison of perioperative clinical benefits of preemptive vs. conventional thoracic epidural analgesia with hydromorphone and ropivacaine in patients undergoing thoracotomy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000813785
Enrollment
30
Registered
2013-07-24
Start date
2008-08-20
Completion date
2009-06-19
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Preemptive analgesia is known to decrease the sensitization of the central nervous system and reduce subsequent amplification of nociceptive stimuli. This study investigates whether preemptive thoracic epidural analgesia (TEA) demonstrates overall clinical advantages during intra and postoperative period. Patients scheduled for open thoracotomy, are randomly allocated to one of two groups to start TEA either before surgical incision (Preemptive group) or at the end of operation (Nonpreemptive group). Incidence of hypotension during surgery are recorded. Numerical rating scales for pain and the incidence of side effects such as nausea, pruritis, sedation, hypotension and respiratory depression are recorded at postoperative 2, 6 24, 48 hr. Functional vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) are measured before and 24, 48 hr after operation. Pain control at postoperative 6 month are investigated.

Interventions

patients scheduled for open thoracotomy with a thoracic epidural catheter inserted on the previous day of the surgery, were randomly allocated to one of two groups. The Preemptive Group is the intervention group in this trial. 1) thoracic epidural analgesia (TEA) applied preemptively before surgery (Preemptive group) 2) thoracic epidural analgesia (TEA) applied at the end of surgery (Nonpreemptive group) After induction of anesthesia, patients in Preemptive group received 10ml 0.1% ropiva

patients scheduled for open thoracotomy with a thoracic epidural catheter inserted on the previous day of the surgery, were randomly allocated to one of two groups. The Preemptive Group is the intervention group in this trial. 1) thoracic epidural analgesia (TEA) applied preemptively before surgery (Preemptive group) 2) thoracic epidural analgesia (TEA) applied at the end of surgery (Nonpreemptive group) After induction of anesthesia, patients in Preemptive group received 10ml 0.1% ropivacaine with 100 ug hydromorphone via an indwelling epidural catheter followed by a continuous infusion with an infusion pump (Aim(Registered Trademark) plus, Abbott Laboratories, U.S.A) at least 30 minutes before surgical incision. Patients in Nonpreemptive group received the same epidural 10ml drug administration and a continuous TEA regimen at the end of surgery. A continuous TEA regimen for both groups was comprised of 0.15% ropivacaine with 8ug/ml hydromorphone at the rate of basal 5ml/hr and a 3ml bolus with a 15 minute lockout interval. The incidence of hypotension during surgery was recorded. Hypotension was defined as a persistent decrease of systolic blood pressure greater than 30% of baseline or mean blood pressure less than 60 mmHg, that was not due to a bleeding episode, and that required a continuous infusion of inotropics or vasopressors despite three or more consecutive intravenous (IV) bolus injections of ephedrine or phenylephrine. The amount of TEA and IV fentanyl administered during surgery was recorded. Postoperative analgesia was controlled with TEA and rescue IV morphine or oral tramadol and acetaminophen combination (Ultracet(Registered Trademark)). The duration of this trial is 48 hours. Postoperative follow up of study 1. Consumption of TEA after surgery was recorded. Numerical rating scales at rest and cough (NRS, a scale of 0 – 10 in which 0 is no pain and 10 is worst pain) were used to assess the pain severity. 2. The incidence of intraoperative hypotension, and side effects including nausea, pruritis, sedation, hypotension and respiratory depression were recorded at postoperative 2, 6, 24, and 48 hr. 3. Functional vital capacity (FVC) and forced expiratory volume in 1 second (FEV1) were measured by a portable spirometry (Micro, Micro Medical Limited, Rochester, U.K.) before surgery and at postoperative 24 and 48 hr. 4.Persistence of pain and its characteristics on the surgical wound at postoperative 6 month was also investigated.

Sponsors

Samsung Seoul Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. aged between 20-75 years 2. American Society of Physical Status (ASA PS) I-II 3. scheduled for open thoracotomy with a thoracic epidural catheter inserted on the previous day of the surgery

Exclusion criteria

patients with renal, hepatic, or cardiac dysfunction, neurologic disorder, previous opioids, corticosteroids, or nonsteroidal anti-inflammatory drugs within one week of surgery, previous anticoagulation therapy, allergy to local anesthetics or opioids, or inability to use patient controlled epidural analgesia (PCEA) or perform portable pulmonary function test.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026