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

ConditionsAcute Post Operative PainLaparotomyEpidural Analgesia
Trial statusCompleted
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCiusss de L'Est de l'Île de Montréal

About this trial

Pain control after surgery is a crucial component of postoperative recovery. Thus, in open abdominal surgery, the use of TEA (Thoracic epidural analgesia) has become a gold standard. However, analgesia may still remain a challenge, especially in patients with large incision abdominal incisions.

To address this problem, the use of the PIEB (Programmed intermittent epidural bolus) mode has been proposed, because it offers a better spread of the epidural medication.

Only a few studies have evaluated the superiority of this PIEB mode in open abdominal surgery, yielding conflicting results. However, PIEB showed to be at least as effective in controlling pain as CEI, and clinical experience shows that it can be a valuable tool, especially in patients with a large laparotomy incision.

However, the optimal dosage of the PIEB mode has never been determined, Furthermore, it is known whether men and women have the same dosage needs to achieve adequate analgesia since most studies have failed to account for sex-based differences in postoperative analgesia.

Hence, the main objective of this study will be to determine the optimal volume dose of the PIEB delivered at a fixed interval of 60 min in patients undergoing surgery using a large midline laparotomy incision. The optimal dose for male and female patients will be determined separately by evaluating men and women in two independent groups. We hypothesize that the optimal dose of the PIEB that will provide effective analgesia in 90% of patients on the first postoperative day will range between 5 and 10 mL, for both groups.

The primary outcome in both groups is successful analgesia. It is defined as a requirement of 5 or less patient-controlled epidural boluses between 8 AM and 8 PM on the first postoperative day.

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

18-85 years old

ASA I to III

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Programmed intermittent epidural bolus 5 ml

    Drug

    patients in this group will receive a programmed epidural intermittent bolus of 5 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \> 4/10

  • Programmed intermittent epidural bolus 6 ml

    Drug

    patients in this group will receive a programmed epidural intermittent bolus of 6 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \> 4/10

  • Programmed intermittent epidural bolus 7 ml

    Drug

    patients in this group will receive a programmed epidural intermittent bolus of 7 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \> 4/10

  • Programmed intermittent epidural bolus 8 ml

    Drug

    patients in this group will receive a programmed epidural intermittent bolus of 8 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \> 4/10

  • Programmed intermittent epidural bolus 9 ml

    Drug

    patients in this group will receive a programmed epidural intermittent bolus of 9 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \> 4/10

  • Programmed intermittent epidural bolus 10 ml

    Drug

    patients in this group will receive a programmed epidural intermittent bolus of 10 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \> 4/10

Treatment groups

60 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: F5 ml PIEBExperimental treatment 1 intervention
Group B: F6 ml PIEBExperimental treatment 1 intervention
Group C: F7 ml PIEBExperimental treatment 1 intervention
Group D: F8 ml PIEBExperimental treatment 1 intervention
Group E: F9 ml PIEBExperimental treatment 1 intervention
Group F: F10 ml PIEBExperimental treatment 1 intervention
Group G: M5 ml PIEBExperimental treatment 1 intervention
Group H: M6 mL PIEBExperimental treatment 1 intervention
Group I: M7 mL PIEBExperimental treatment 1 intervention
Group J: M8 mL PIEBExperimental treatment 1 intervention
Group K: M9 mL PIEBExperimental treatment 1 intervention
Group L: M10 mL PIEBExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Successful analgesia

Defined by a requirement of a maximum of 5 Patient controlled epidural analgesia (PCEA) boluses on postoperative day 1

Time frame
from 8 AM until 8 PM on the first postoperative day

Secondary outcomes

1

Incidence of motor block according to group

Incidence of Bromage Scale score of at least 3 (bromage motor blockade score from 1-4 where 1: complete motor blockade and 4: absence of motor block)

Time frame
At 24h postoperatively
2

Incidence of hypotension according to group

Systolic blood pressure \< 90 mmHg

Time frame
At 24h postoperatively
3

level of sensory block to ice according to group

Comparison of the level of sensory block to ice according to group (measured using loss of sensation to cold using an ice cube)

Time frame
At 24h postoperatively
4

Quality of Recovery-15 (QoR-15) score

Comparison of Quality of Recovery-15 (QoR-15) score according to group (scale of 0-150 where 0: very poor recovery and 150: best possible recovery)

Time frame
At 48 h postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ciusss de L'Est de l'Île de Montréal

Lead sponsor

Maisonneuve-Rosemont Hospital

Sponsor institution

Source ClinicalTrials.gov

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