Effectiveness of Transverse Abdominus Plane Catheter Blocks to Patient-controlled Analgesia in Laparoscopic Colon Resections
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|ClinicalTrials.gov Identifier: NCT01592630|
Recruitment Status : Withdrawn (Investigator Left Institution)
First Posted : May 7, 2012
Last Update Posted : December 6, 2016
The control of postoperative pain has become a major issue in surgery awareness and it is considered an important measurement of patient satisfaction. Improvements in pain relief, including stopping pain before it starts (i.e. preemptive treatment) is of great benefit to the surgical patient. When pain is aggressively addressed, patients respond by recovering faster.
The use of opioids remains the mainstay to minimize postoperative pain. Lately, long acting local anesthetic wound infiltration has been widely recognized as a useful adjunct to multimodal postoperative pain management. On that basis, a system that delivers a continuous local anesthetic to the surgical wound was developed, and better pain control has been achieved after several surgical procedures.
In patients undergoing abdominal procedures, such as colon resection, adequate pain control remains an issue. It is known that innervation to the antero-lateral abdomen is provided by sensory nerves T7-L1, ilioinguinal and iliohypogastric nerves, which travel through the transverse abdominis muscle plane (TAP). Local anesthetic block of these nerves has been described and has shown to be effective for immediate postoperative pain control.
Recently, the use of the On-Q pain relief system with catheters placed within the TAP has been evaluated. Published results have shown significant improvement of pain control (Forastiere). The idea of placing the pain catheters at the TAP plane seems to be more coherent with the anatomical distribution of the sensory nerves trunks. Due to the lack of prospective trials investigating the effectiveness of a continuous wound infusion with local anesthetics after general surgery procedures the investigators sought to determine the efficacy of this technique after laparoscopic colon resection procedures.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Disorders Observation of Neuromuscular Block||Drug: 0.2% ropivacaine Drug: Saline||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Effectiveness of Adding Transverse Abdominus Plane (TAP) Catheter Blocks to Patient-controlled Analgesia (PCA) in Laparoscopic Colon Resections: a Prospective, Randomized Controlled Study|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
Subjects with TAP catheters attached to the On-Q pump with 0.2% ropivacaine
Drug: 0.2% ropivacaine
On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters
Other Name: Experimental drug
Placebo Comparator: Saline
Subjects with TAP catheters attached to the On-Q pump with saline
On-Q pumps containing saline to be attached to TAP catheters
Other Name: Control/Placebo
- Time to flatus [ Time Frame: 1 week ]Post-operative time measurement for the patient to pass flatus
- Hospital Length of Stay [ Time Frame: 1 week ]Post-operative time measurement until patient discharge
- Passage of Stool [ Time Frame: 1 week ]Post-operative time measurement for the patient to pass stool
- Narcotic use [ Time Frame: 1 week ]Post-operative measurement of patient narcotic requirements
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592630
|United States, Connecticut|
|Colon and Rectal Surgery|
|Stamford, Connecticut, United States, 06902|
|Stamford, Connecticut, United States, 06904|