Pain, Postoperative, Postoperative Nausea and Vomiting
Conditions
Brief summary
The purpose of this prospective, blinded, randomized clinical trial is to investigate whether a ventilator-piloted PRM at the end of laparoscopic bariatric surgery could reduce overall postoperative pain and nausea.
Interventions
PROCEDUREPulmonary recruitment maneuver
The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
PROCEDURELaparoscopic bariatric surgery
DEVICEVentilator
Sponsors
Region Östergötland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* elective laparoscopic bariatric surgery (LBS) * American Society of Anaesthesiologists (ASA) physical status classification I-II (with the exception of body mass index over 35 kg/m2) * written consent
Exclusion criteria
* conversion to open surgery * complication, Clavien-Dindo grade ≥ II
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain | 4, 12, 24, 36 and 48 hours after surgery | A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Nausea | 4, 12, 24, 36 and 48 hours after surgery | A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pulmonary Recruitment Maneuver Ventilator-piloted pulmonary recruitment maneuver at the end of laparoscopic bariatric surgery.
Pulmonary recruitment maneuver: The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator | 79 |
| Control Group Ordinary ventilation at the end of laparoscopic bariatric surgery.
Laparoscopic bariatric surgery
Ventilator | 71 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 19 | 24 |
| Overall Study | Protocol Violation | 2 | 5 |
Baseline characteristics
| Characteristic | Pulmonary Recruitment Maneuver | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 47 years | 44 years | 46 years |
| BMI | 38 kg/m2 | 38 kg/m2 | 38 kg/m2 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Sweden | 79 participants | 71 participants | 150 participants |
| Sex: Female, Male Female | 67 Participants | 54 Participants | 121 Participants |
| Sex: Female, Male Male | 12 Participants | 17 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Postoperative Pain
A questionnaire with a numeric rating scale (NRS) is used to evaluate pain intensity at 4, 12, 24, 36 and 48 hours postoperatively to assess pain intensity. The scale includes even numbers from 0 to 10, where 0 signifies no pain, and 10 signifies the worst imaginable pain.
Time frame: 4, 12, 24, 36 and 48 hours after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pulmonary Recruitment Maneuver | Postoperative Pain | 12 hr | 2 score on a scale |
| Pulmonary Recruitment Maneuver | Postoperative Pain | 36 hr | 2 score on a scale |
| Pulmonary Recruitment Maneuver | Postoperative Pain | 24 hr | 2 score on a scale |
| Pulmonary Recruitment Maneuver | Postoperative Pain | 48 hr | 1 score on a scale |
| Pulmonary Recruitment Maneuver | Postoperative Pain | 4 hr | 3 score on a scale |
| Control Group | Postoperative Pain | 48 hr | 1 score on a scale |
| Control Group | Postoperative Pain | 4 hr | 2 score on a scale |
| Control Group | Postoperative Pain | 12 hr | 3 score on a scale |
| Control Group | Postoperative Pain | 24 hr | 3 score on a scale |
| Control Group | Postoperative Pain | 36 hr | 2 score on a scale |
Secondary
Postoperative Nausea
A questionnaire was used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively. The questionnaire involved a numeric rating scale (NRS) from 0 to 10, where 0 signified no nausea, and10 the worst imaginable nausea.
Time frame: 4, 12, 24, 36 and 48 hours after surgery
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Pulmonary Recruitment Maneuver | Postoperative Nausea | NRS 12 hr | 1 score on a scale |
| Pulmonary Recruitment Maneuver | Postoperative Nausea | 36 hr | 0 score on a scale |
| Pulmonary Recruitment Maneuver | Postoperative Nausea | 24 hr | 0 score on a scale |
| Pulmonary Recruitment Maneuver | Postoperative Nausea | 48 hr | 0 score on a scale |
| Pulmonary Recruitment Maneuver | Postoperative Nausea | 4 hr | 1 score on a scale |
| Control Group | Postoperative Nausea | 48 hr | 0 score on a scale |
| Control Group | Postoperative Nausea | 4 hr | 1 score on a scale |
| Control Group | Postoperative Nausea | NRS 12 hr | 1 score on a scale |
| Control Group | Postoperative Nausea | 24 hr | 0 score on a scale |
| Control Group | Postoperative Nausea | 36 hr | 0 score on a scale |