Skip to main content
Clinical Trials/NCT01095575
NCT01095575
Completed
Not Applicable

Pre- vs. Post-Incisional Epidural Morphine: Higher Postoperative Pain Perception and Extra Morphine Consumption

Tel-Aviv Sourasky Medical Center0 sites40 target enrollmentJanuary 2006

Overview

Phase
Not Applicable
Intervention
normal saline 3 ml, morphine 3mg
Conditions
Pain
Sponsor
Tel-Aviv Sourasky Medical Center
Enrollment
40
Primary Endpoint
Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

Background and Objectives: Neuraxial administration of morphine is an effective way of controlling postoperative pain and reducing analgesic consumption. Several animal models have demonstrated that preemptive administration of neuraxial narcotics reduced pain while others revealed the induction of post-incisional hypersensitivity. There have been no consistent results in clinical setting either. This double blind, randomized study compared the effects of PRE- vs. POST-incisional administration of neuraxial morphine on postoperative pain perception and analgesic requirements over 48 hours following laparotomy for open colectomy under standardized general anesthesia.

Methods: Twenty patients received epidural morphine (3 mg) pre-incision and saline after wound closure (MO1 group), and 20 patients received epidural saline before incision and morphine after wound closure (MO2 group). Postoperatively, all patients received boluses of morphine (1.5 mg) via intravenous patient-controlled analgesia (IV-PCA), and rescue doses of intramuscular diclofenac (75 mg) every 6 hours, as needed.

Registry
clinicaltrials.gov
Start Date
January 2006
End Date
January 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1.adults scheduled for elective laparotomy and colon surgery with the duration of surgery expected to last for at least 2 hours.

Exclusion Criteria

  • allergy to morphine, fentanyl, non-steroidal anti-inflammatory drugs or any of the intraoperative anesthetic medications
  • use of opioids, sedatives or stimulants during 21 days prior to surgery, psychiatric illness
  • congestive heart failure, respiratory failure, neuromuscular disease or presence of a chronic pain syndrome
  • Pregnant women and patients unable to sign their own consent form

Arms & Interventions

group 1

NS preoperatively and MO postoperatively

Intervention: normal saline 3 ml, morphine 3mg

group 2

MO preoperatively and NS postoperatively

Intervention: normal saline 3 ml, morphine 3mg

Outcomes

Primary Outcomes

Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)

Time Frame: 48 hours

Secondary Outcomes

  • Consumption of analgesics(48 hours)

Similar Trials