Pregabalin to improve postoperative recovery in bariatric surgery: a parallel, randomized, double-blinded, placebo-controlled study

Figures & data

Figure 1 CONSORT diagram for the study.

Abbreviation: CONSORT, consolidated standards of reporting trials.

Table 1 Baseline characteristics and operative data

Characteristics	Placebo	Pregabalin
Age (years)a	38 (32–47)	35 (29–39)
Weight (kg)a	110 (105–119)	110 (101–125)
Height (cm)a	165 (161–168)	162 (157–167)
BMI (kg/m^2)a	40.6 (39–43.0)	41.1 (39.4–47.1)
Male sexb	5 (16.7%)	2 (6%)
Associated diseaseb	22 (73.3%)	18 (60.0%)
Hypertension	17 (56.7%)	11 (36%)
Diabetes mellitus	4 (13.3%)	7 (23%)
Hepatic steatosis	2 (6.7%)	4 (13%)
Others	22 (73%)	18 (60%)
Physical condition (ASA)b	1 (3%)	2 (6%)
I	25 (83%)	27 (90%)
II	4 (13%)	1 (3%)
III
Smokingb	2 (6.7%)	0 (0%)
Previous surgeryb	24 (80%)	24 (80%)
Previous abdominal surgeryb	18 (60%)	19 (63%)
Duration of surgery (minutes)a	107 (95–125)	117 (88 to 128)
Intraoperative hydrationa	1,500 (1,500–2,000 mL)	1,500 (1,500 mL)
Intercurrenceb	2 (6%)	1 (3%)

Notes:

a Values expressed as the median and first and third quartiles.

b Variables expressed in absolute and relative frequencies.

Abbreviation: ASA, American Society of Anesthesiologists.

Table 2 Quality of recovery measured using the QoR-40 questionnaire (40–200) and hospitalization time according to the intervention group

Variable	Placebo	Pregabalin	P-value
QoR-40	182 (13)	183 (9)	0.59
Time to hospital discharge (days)	3 (0)	3 (0)	1.00

Notes:

a Values are expressed as mean and SD. QoR-40, Quality of Recovery, with 40 questions about the quality of postanesthetic recovery. Higher values indicate a greater degree of satisfaction.

Table 3 Subcomponents of the QoR-40 questionnaire by study groups evaluated 24 hours after surgery

Variables	Placebo (n=30)			Pregabalin (n=30)
	Median	First quartile	Third quartile	Median	First quartile	Third quartile	P-value
Physical comfort	54	49	58	53	50	57	0.64
Physical independence	25	24	25	25	23	25	0.43
Support	35	31	35	35	32	35	0.63
Emotional status	40	33	45	42	36	44	0.57
Pain	33	31	34	33	32	35	0.51

Note: QoR-40: Quality of Recovery, with 40 questions about the quality of postanesthetic recovery.

Table 4 Occurrence of paina, nausea, vomiting, and morphine consumption in the postoperative period according to the intervention group

Time point	Placebo	Pregabalin	P-value
End of surgeryb	0.7 (0–1.5)	0.5 (0–1.1)	0.67
Admission to the PACU at restb	1.7 (0.7–2.6)	2.3 (1.3–3.3)	0.35
Admission to the PACU with cough stimulusb	1.9 (0.9–2.9)	2.7 (1.6–3.9)	0.26
After 1 hour in the PACU at restb	3.7 (2.5–4.9)	3.5 (2.4–4.3)	0.74
After 1 hour in the PACU with cough stimulusb	4.3 (3.1–5.4)	4.1 (3.2–5)	0.85
24 hours after surgery, at restb	1.8 (1.1–2.6)	1 (0.5–1.5)	0.06
24 hours after surgery, with cough stimulusb	2.9 (2.1–3.6)	2.3 (1.4–2.9)	0.15
Morphine use in the PACUc	15 (50.0%)	18 (60.0%)	0.43
Time to use morphine in the PACU (minutes)b	11 (13–17)	13 (7–20)	0.67
Total dose of morphine in the PACU (mg)b	3.4 (1.7–5.1)	2.5 (1.5–3.5)	0.37
Morphine use on POD 1 (number of patients)c	5 (16.7%)	3 (10.0%)	0.70
Total dose of morphine on POD 1 (mg)b	0.4 (0–0.9)	0.2 (0–0.4)	0.3
PACU discharge time (minutes)b	90 (74–106)	84 (72–95)	0.5
Nausea in the PACUc	10 (33.3%)	12 (40.0%)	0.59
Vomiting in the PACUc	0 (0.0%)	2 (6.7%)	0.49
Nausea on POD 1c	6 (20.0%)	12 (40.0%)	0.15
Vomiting on POD 1c	3 (10.0%)	6 (20.0%)	0.47

Notes:

a Reported unit is based on NRS pain score.

b Values are expressed as mean and 95% CI.

c Values are expressed in absolute and relative frequencies, number of patients who presented the event.

Abbreviations: PACU, postanesthesia care unit; POD, postoperative day; NRS, numerical rating scale.

Figure S1 QoR-40.

Note: QoR-40: Quality of Recovery, with 40 questions about the quality of postanesthetic recovery.