Intravenous or Intra-abdominal Local Anesthetics for Postoperative Pain Management.

Uterine Cancer Clinical Trial

— PoPuLAR  

Official title:

A Comparison Between Continuous Infusion vs. Patient Controlled Intraabdominal Injection of Local Anesthetics for Treatment of Postoperative Pain After Abdominal Hysterectomy. A Randomized, Double-blind Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492179
• Other study ID #: 20111212
• Status: Completed
• Phase: Phase 4
• First received: December 12, 2011
• Last updated: May 25, 2014
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Institutional Review Board, Sweden:
• Study type: Interventional

Clinical Trial Summary

Local anesthetics (LA) are increasingly used for postoperative pain management. Speicifically, several studies have found benefit of LA injected intra-abdominally following abdominal hysterectomy. However, it remains unclear whether the pain relief seen is due to local anesthetic mechanisms within the abdominal cavity or through systemic absorption. The aim of this study is to assess whether lidocaine administered intravenously has similar analgesic efficacy as the same dose administered intra-abdominally in patients undergoing abdominal hysterectomy. All patients would have rescue analgesia using the patient controlled analgesia (PCA) pump with morphine in order to achieve adequate pain management during 24 h.

Description:

Abdominal hysterectomy with or without salipingo-oophorectomy is associated with moderate-severe postoperative pain. Poor pain control in the postoperative period can lead to increased postoperative morbidities and poor quality of life. Furthermore, an emerging clinical literature suggests that acute pain may rapidly evolve into chronic pain if poorly treated. A meta-analysis of the literature found that > 30% patients had chronic pain one year after abdominal hysterectomy (5). Therefore, efficient postoperative pain management is imperative for the patient and is one of the new pain management standards recommended recently.

Local anesthetics (LA) have been infiltrated subcutaneously, infused intra-abdominally, as well as injected into the peritoneal cavity as a single dose at the end of the operation following abdominal hysterectomy with variable effects. When injected as a single dose, analgesia is limited to approximately 2-4 hours due to the short duration of action of local anesthetics. In one recent study, the authors used a catheter inserted intra-abdominally and local anesthetic or placebo infusion into the abdominal cavity for 24 h postoperatively and found a reduction in postoperative analgesic requirements by 40% during 4-24 h. In another study, the investigators found that LA injected intermittently intra-abdominally resulted in better pain relief compared to intra-abdominal infusions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• ASA 1-2

• 30 - 75 yrs

• Informed consent

• 50 - 100 kg

Exclusion Criteria:

• Allergy to LA

• Chronic pain

• Major liver/kidney insufficiency

• AV Block 1-2 Participation in another clinical trial

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leiomyoma
• Pain, Postoperative
• Persistent Post-menpausal Bleeding
• Uterine Cancer
• Uterine Myoma
• Uterine Neoplasms

Intervention

Drug:
• Normal saline
Normal saline would be administered intravenously and intra-abdominally.
• Intravenous Lidocaine
Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.
• Intra-abdominal Lidocaine
Lidocaine 5 mg/ml; 100 mg would be administered intraoperatively intra-abdominally and subsequently 50 mg/h as intermittent injection intra-abdominally during 24 h

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Total rescue morphine consumption during 0 - 24 h would be the primary endpoint	0 - 24 h postoperatively	No
Secondary	Postoperative pain	Postoperative pain measured on the numeric rating scale (0 - 10) would be measured at 4 h	4 h postoperatively	No
Secondary	Plasma concentration of lidocaine	The plasma concentration of LA lidocaine would be analysed at 24 h in order to assess whether the LA absorption from the abdomen is similar to that administered intravenously.	24 h	Yes
Secondary	Length of Hospital stay	The time to discharge home would be assessed using standardized criteria for home discharge.	1-5 days	No