PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Pain control after surgery is a major factor in the patient's quality of recovery. In open abdominal and gynecologic surgery, TEA (Thoracic epidural analgesia) are installed when feasible to freeze pain signaling from the surgical site and decrease the patient's pain level.

After installation, medication has historically been infused as a CEI (continuous epidural infusion). However, more and more anesthesiologists prescribe PIEB (Programmed intermittent epidural boluses) instead of continuous infusion, with the intent of offering better analgesia. In both cases, patient-controlled epidural analgesia is also prescribed, which allows the patient to auto-administer additional boluses of local anesthetics.

Despite many studies demonstrating benefits in the obstetrical population, only a few studies in the recent years have been completed regarding the advantage of PIEB for patients undergoing open abdominal and gynecologic surgeries. They yielded conflicting results. Some concluded in a benefit from PIEB, while others demonstrated no difference. Either way, PIEB showed to be at least as effective in controlling pain as CEI, confirming the clinical decision of prescribing the former.

Keeping the effectiveness of it in mind, dosage has however never been tested and is currently prescribed empirically. This would be the main objective of this study.

Using a biased coin up-down sequential allocation method, we will conduct a clinical trial to identify the optimal dosage of low-dose bupivacaine using a PIEB protocol. We believe that the said dosage to achieve successful analgesia should be in the interval of 5 to 10 ml every 60 minutes. Therefore, the doses that will be tested will be 5, 6, 7, 8, 9 and 10 ml every 60 minutes, corresponding respectively to groups 5, 6, 7, 8, 9 and 10.

Our primary outcome will be measured post-op day 1. Successful analgesia will be defined as 5 or less PCEA boluses during those hours.

Secondary outcomes will be the incidence of motor block and hypotension, comparison of the level of sensory block according to group, comparison of patient satisfaction according to group and comparison of Quality of Recovery-15 score at 48h post-op according to group.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ciusss de L'Est de l'Île de Montréal

Criteria

Inclusion Criteria:

• 18-85 years old

• ASA I to III

Exclusion Criteria:

• Contraindication to TEA: Coagulopathy, sepsis or local infection at the epidural insertion site, patient refusal

• Inability to site the epidural catheter

• Inability to use PCEA/Communication barrier

• Daily opioid use

• Planned postoperative admission to the intensive care unit

• Patient refusal

• Predefined criteria for exclusion after inclusion: Failure to obtain a sensory block to ice in the Post Anesthesia Care Unit (PACU)(see Methods), Reoperation within 1 postoperative day