Objective
The objective of the study was to determine whether transversus abdominis plane (TAP) block improves the early postoperative quality of recovery (QoR-40). The secondary objectives measured postoperative pain, length of stay, and narcotic use.
Study Design
This was a randomized, single-blinded trial of TAP block versus no block on women undergoing laparoscopic hysterectomy. TAP block patients received 20 mL of 0.5% ropivacaine with epinephrine 1:200,000 placed under ultrasound guidance on each side. The outcomes were measured using validated quality of recovery questionnaires (QoR-40), visual analog scales (VAS) for pain, and documented narcotic use in the electronic medical record.
Results
In 58 women, no differences in demographics were noted between groups. Comparisons of pain and recovery between the 2 groups showed no differences. There was no decrease in narcotic use or length of stay among those who received the TAP block.
Conclusions
TAP block does not improve postoperative QoR-40 scores or VAS pain scores following laparoscopic hysterectomy, nor does it decrease narcotic pain medication use.
The rates of laparoscopic hysterectomy have been increasing in recent years, with benefits over abdominal surgery well known and an effort to make hysterectomy an outpatient procedure when feasible. Hospital admissions as a result of complications following ambulatory surgery are rare ; however, obtaining adequate postoperative analgesia is a major obstacle to early hospital discharge. Preoperative screening for obstructive sleep apnea causes additional considerations for those that may require narcotics postoperatively for pain control.
The purpose of this study was to test a regional method of pain control in patients undergoing laparoscopic hysterectomy.
The transversus abdominis plane (TAP) block is a technique for achieving single entry point multidermatome analgesia. Local anesthetic is deposited below the fascial plane between the internal oblique and the transverse abdominis muscles, thus interrupting the sensory innervation to the anterior abdominal wall and peritoneum. Clinical trials have shown a significant reduction in narcotic consumption and recovery times following TAP block in both open and laparoscopic surgery, but there are limited data on the outcomes after laparoscopic hysterectomy.
Our primary objective was to determine whether TAP block would improve the early postoperative quality of recovery score (QoR-40), and secondary objectives were to evaluate postoperative pain and narcotic medication use following laparoscopic hysterectomy. We anticipated that if the TAP block could improve quality of recovery and decrease narcotic use, then more laparoscopic hysterectomies could be performed on an ambulatory basis.
Materials and Methods
This study was a randomized, single-blinded controlled trial. We obtained study approval from the MetroHealth Medical Center Institutional Review Board, and all women undergoing laparoscopic hysterectomy by a single surgeon between April and September 2011 were approached to participate. Patients were excluded if they were on chronic narcotic pain medications or if they had allergy to local anesthetic.
Laparoscopic hysterectomy was performed using 2 techniques. One method was a 4 trocar procedure (10 mm incisions in the umbilicus and suprapubic midline and 5 mm incisions in the right and left lower quadrants), and the other was by using a laparoendoscopic, single-site technique with a multichannel port at the umbilicus. Uteri were morcellated vaginally or through the suprapubic port using an endoscopic morcellator device.
After written informed consent was obtained, randomization was performed on the day of surgery by the research pharmacy using a computer-based block randomization plan, and the study drug (40 mL of 0.5% ropivacaine with epinephrine 1:200,000) was dispensed if the patient was randomized to the TAP block. At the conclusion of the hysterectomy procedure, while under general anesthesia, the anesthesia pain management team placed the block under ultrasound guidance. The block consisted of 20 mL of the ropivicaine with an Epi solution on each side of the abdominal wall. There was no sham or placebo injection in the control group, so the surgical team was not blinded to the randomization, but the patients were blinded to their treatment group. Standard pain management with oral and intravenous medications were given as needed, and all of the patients received 30 mg of intravenous ketorolac at the conclusion of the surgery.
Measurement of postoperative pain and recovery following total laparoscopic hysterectomy surgery with or without TAP block was performed on postoperative day 1 through the use of a validated quality of recovery questionnaire, the QoR-40. The QoR-40 is a 40-item quality of recovery score measuring 5 dimensions: physical comfort (12 items), emotional state (9 items), physical independence (5 items), psychological support (7 items), and pain (7 items). Each item is rated on a 5-point Likert scale. The QoR-40 has a possible score of 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery). It was specifically designed to measure a patient’s health status after surgery and anesthesia, and it has been proposed as a measure of outcome in clinical trials.
In a critical review, the QoR-40 was found to be the best measure of recovery following ambulatory procedures. Numeric visual analog scales for pain and recovery and narcotic pain medication use were obtained at 2 and 24 hours postoperatively using both the EMR and a personal medication diary. Inpatient or telephone interviews were conducted by either the research coordinator or members of the surgical team to obtain postoperative day 1 QoR-40 questionnaire data.
A sample size of 25 patients per group was needed to provide 80% power to detect a 10 point difference in QoR-40 scores between the 2 groups. An additional 8 patients were approached to participate to account for any who might be lost to follow up. Study data were collected and managed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at MetroHealth Medical Center. REDCap is a secure, web-based application designed to support data capture for research studies. Comparisons between groups were done using 2- tailed Student t tests or a Mann-Whitney U test for continuous data and Fisher’s exact tests for categorical data. Statistical analysis was performed using SPSS version 17.0 (SPSS Inc, Chicago, IL).
Results
Fifty-eight women were approached, and 57 women were enrolled between April and September 2011. One patient was lost to follow-up, and 1 patient was excluded from analysis secondary to intraoperative conversion to laparotomy. The flow of enrollment is demonstrated in the Figure .
Table 1 describes the preoperative demographics and indications for the hysterectomy as well as any concomitant procedures performed. There were no differences in any of these factors. The primary outcome of the overall QoR-40 score was not significantly different in those who received the TAP block, 168.0 (125-195) versus 169.5 (116-194) in the no-block group ( P = .533). When the 5 dimensions of recovery were analyzed separately, there was a slight difference in the pain subset of scores 26.0 (16-24) versus 30.0 (19-34) ( P = .012) ( Table 2 ). There was no difference in the amount of narcotic medication used (11.7 mg (0-24) morphine versus 11.8 mg (0-27) ( P = .474) or in the numeric pain scores (50.0 [0-100] versus 60.0 [20-100]) ( P = .447).
| Demographic | TAP block (n = 28) | No block (n = 28) | P value a |
|---|---|---|---|
| Age, y | |||
| Mean (SD) | 46.2 (5.1) | 43.5 (7.9) | .145 |
| Median | 46.0 | 44.0 | |
| Range | 38–61 | 22–58 | |
| Race, n (%) | |||
| Black | 13 (46.4) | 16 (57.1) | .680 |
| White | 9 (32.1) | 9 (32.1) | |
| Hispanic | 3 (10.7) | 2 (7.1) | |
| Other | 3 (10.7) | 1 (3.6) | |
| Insurance, n (%) | |||
| Private | 11 (39.3) | 14 (50.0) | .591 |
| Public | 17 (60.7) | 14 (50.0) | |
| BMI, kg/m 2 | |||
| Mean (SD) | 31.1 (7.5) | 29.9 (7.3) | .548 |
| Median | 31.3 | 29.6 | |
| Range | 19.0–46.7 | 18.8–45.9 | |
| BMI category | .222 | ||
| Normal weight (18-24.9) | 10 (35.7%) | 8 (28.6%) | |
| Overweight (25-29.9) | 2 (7.1%) | 8 (28.6%) | |
| Obese (30-39.9) | 12 (42.8%) | 9 (32.1%) | |
| Morbidly obese (≥40) | 4 (14.3%) | 3 (10.7%) | |
| Preoperative diagnoses | .889 | ||
| Fibroids | 17 (60.7%) | 14 (50.0%) | |
| CPP | 7 (25.0%) | 7 (25.0%) | |
| Endometriosis | 5 (17.8%) | 4 (14.3%) | |
| DUB | 1 (3.6%) | 0 | |
| Prolapse | 2 (7.1%) | 1 (3.6%) | |
| Concomitant procedures | |||
| Sling or ant/post repair | 2 (7.1%) | 5 (17.8%) | .421 |
| Laparoscopic vault suspension | 2 (7.1%) | 1 (3.6%) | .999 |
| Excision of endometriosis | 5 (17.8%) | 3 (10.7%) | .705 |
| BSO or USO | 5 (17.8%) | 3 (10.7%) | .705 |
| LESS technique | 4 (14.3%) | 2 (7.1%) | .669 |
| Variable | TAP block (n = 28) | No block (n = 28) | P value |
|---|---|---|---|
| QoR score by recovery category | |||
| Comfort | 47.5 (31–59) | 50.0 (33–58) | .987 |
| Emotions | 39.5 (25–45) | 41.0 (23–45) | .705 |
| Independence | 20.0 (13–25) | 21.0 (10–25) | .850 |
| Support | 35.0 (23–35) | 35.0 (26–35) | .913 |
| Pain | 26.0 (16–24) | 30.0 (19–34) | .012 |
| QoR-40 overall score | 168.0 (125–195) | 169.5 (116–194) | .533 |
| 2 h numeric pain score | 50.0 (0–100) | 60.0 (20–100) | .447 |
| 24 h numeric pain score | 50.0 (0–80) | 50.0 (0–100) | .841 |
| POD#0 narcotic use (morphine mg) | 11.7 (0–24) | 11.8 (0–27) | .474 |
| POD#1 narcotic use (morphine mg) | 7.5 (3–25) | 9.0 (3–15) | .611 |
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