Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

Study Overview
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Brief Summary
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The use of pre-operative transversus abdominis plane block will reduce pain after outpatient laparoscopic gynecological surgery and improve quality of recovery.

Detailed Description
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75 subjects will be randomly allocated into 3 groups, using a computer generated table of random numbers. Group A (study group) will receive a bilateral TAP block using 15 cc of 0.5% ropivacaine on each side. Group B (control group) will receive 15 cc of sterile normal saline. Group C (study group 2) will receive a bilateral TAP block using 15 cc of 0.25% ropivacaine on each side. Subjects will be premedicated with intravenous (IV) midazolam 0.04 mg/kg. Routine ASA monitors will be applied. Anesthesia will be induced with remifentanil infusion started at 0.1 mcg/kg/minute titrated to keep blood pressure within 20% of the baseline and propofol 1.0 -2.0 mg/kg. Tracheal intubation will be facilitated with rocuronium (0.6 mg/kg) or succinylcholine (1-2mg /kg). After induction, a bilateral TAP block will be performed in both groups, under ultrasound guidance with a transportable ultrasound device (SonoSite, Bothell, WA, USA) and a linear 6-13 MHz ultrasound transducer .Once the EOAM, IOAM and TAM are visualized at the level of the anterior axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe will be prepared in a sterile manner. Then the block will be performed with a 21 G 90mm StimuQuik needle( Arrow International, Reading, PA, USA ) utilizing an in- plane ultrasound-guided technique by three investigators (GDO ,AP). Once the tip of the needle is placed in the space between the IOAM and TAM, and after negative aspiration of blood, 15 cc of 0.5% ropivacaine, 15 cc of 0.25% ropivacaine or sterile normal saline will be administered under direct ultrasonographic guidance. The contralateral block will be performed in the same fashion. Anesthesia will be maintained with sevoflurane titrated to maintain a bispectral index (BIS) between 40-60 , remifentanil infusion started at 0.1mcg/kg/min titrated to keep blood pressure within 20 % of baseline values , and rocuronium that will be administered at the discretion of the anesthesiologist. Upon termination of the surgery, neuromuscular blockade will be antagonized with a combination of neostigmine 0.05mg/kg and glycopyrrolate 0.01 mg/kg. Subjects will also receive ketorolac 30 mg IV after discontinuation of remifentanil for postoperative pain control. Ondansetron 4 mg IV will be administered to prevent postoperative nausea and vomiting. Subjects will be assessed in the OR after extubation for their pain using a numerical rating scale and if pain greater than 4/10 they will receive hydromorphone(10 mcg /kg IV) Subjects will receive IV Hydromorphone in divided doses as needed to achieve a verbal rating score for pain <4 out of 10 In PACU.They will also receive metoclopramide (20 mg IV ) as rescue antiemetic in PACU. The primary and secondary outcomes will be assessed by an independent observer who will be blinded to group allocation (CA, AP, SA, YV, RJM and PF). A study team representative will telephone the participant at 24 hours, to complete the modified quality of recovery (QOR40) survey and ask the following: How much pain they are experiencing 0-10 How and what kind of pain medications have been used since discharge. If they have had any nausea What kind of nausea relief medications have been used since discharge

Official Title
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The Effect of Pre Operative Transversus Abdominis Plane (TAP) Block in the Quality of Recovery of Patients Undergoing Outpatient Laparoscopic Gynecological Surgery: A Prospective, Randomized Blinded Study

Conditions
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Pain, Surgery

Intervention / Treatment
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* Procedure: Transversus abdominis plane block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18-64 years Surgery: Outpatient Gynecological laparoscopic surgery ASA status: I and II Fluent in English Exclusion Criteria: History of allergy to local anesthetics History of chronic opioid use Pregnant patients BMI greater than 30 Drop-out criteria: Patient or surgeon request Complications related to the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ropivacaine 0.05%<br>Subject received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side | Procedure: Transversus abdominis plane block<br>* A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.<br>* Other names: TAP block;|
| Placebo Comparator: Normal Saline<br>Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline. | Procedure: Transversus abdominis plane block<br>* A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.<br>* Other names: TAP block;|
| Active Comparator: Ropivacaine 0.25%<br>Subjects received a bilateral transversus abdominis plane block using 15cc of 0.25% ropivacaine on each side | Procedure: Transversus abdominis plane block<br>* A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.<br>* Other names: TAP block;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery | The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery. | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Burden During Early Recovery From Anesthesia | Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable. | Post Operative | 
| Opioid Pain Medications Consumed During the First 24 Hours Post Surgery | Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge | 24 hours | 
| Time to Hospital Discharge Readiness | Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, TAP block, Laparoscopic, Gynecologic