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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: normal saline 3 ml, morphine 3mg

• Registration Number: NCT01095575
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study Completion: 2008-01
• Status Verified: 2010-03
• Study First Submitted: 2010-03-28
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-30
• Last Update Submitted: 2010-04-09
• Last Update Posted: 2010-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 40

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 1	normal saline 3 ml, morphine 3mg	NS preoperatively and MO postoperatively
group 2	normal saline 3 ml, morphine 3mg	MO preoperatively and NS postoperatively

Primary Outcome Measures

Name	Time	Method
Subjective pain intensity, using a visual analogue scale (VAS) from 0 (no pain) to 10 (unbearable pain)	48 hours

Secondary Outcome Measures

Name	Time	Method
Consumption of analgesics	48 hours