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The purpose of this study is to compare quality of recovery as well as peri-operative systemic opiates use and pain scores in patients undergoing laparoscopic or robotic hysterectomy when local anesthetic versus Quadratus Lumborum nerve block (QL-2) is added to the standard pain management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL Block | Experimental |
| |
| Local Anesthesia at incision site | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local anesthesia at incision site | Drug | 20 ml of 0.25% Bupivacaine will be given at incision site |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 7 questions assessing pain with a maximum score of 35 and a minimum score of 5, a lower score indicating greater pain. | 24 hours after anesthesia |
| Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 12 questions assessing physical comfort with a maximum score of 60 and a minimum score of 12, a lower score indicating a worst outcome. | 24 hours after anesthesia |
| Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 5 questions assessing physical independence, with a maximum score of 25 and a minimum score of 5, with a lower score indicating a worst outcome. | 24 hours after anesthesia |
| Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 7 questions assessing Psychological support, with a maximum score of 35 and a minimum score of 7, with a lower score indicating a worst outcome. | 24 hours after anesthesia |
| Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 9 questions assessing emotional state, with a maximum score of 45 and a minimum score of 9, with a lower number indicating a worst outcome. | 24 hours after anesthesia |
| Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Post anesthesia care unit (PACU) immediately postoperatively |
| Pain at Rest as Assessed by the Visual Analog Scale |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Required Morcellation | Intraoperative (about 3 hours) | |
| Specimen Weight | inoperative (about 3 hours) | |
| Duration of Surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Randa J Jalloul, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | QL Block | Sham Local: 20 mls of normal saline given at incision site QL: QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia |
| FG001 | Local Anesthesia at Incision Site | Local anesthesia at incision site: 20 ml of 0.25% Bupivacaine will be given at incision site Sham QL: 20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Local Anesthesia at Incision Site | Local anesthesia at incision site: 20 ml of 0.25% Bupivacaine will be given at incision site Sham QL: 20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 7 questions assessing pain with a maximum score of 35 and a minimum score of 5, a lower score indicating greater pain. | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours after anesthesia |
|
6 weeks post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | QL Block | Sham Local: 20 mls of normal saline given at incision site QL: QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystotomy | Surgical and medical procedures | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Randa J Jalloul, MD | The University of Texas Health Science Center at Houston | 713-566-5749 | Randa.J.Jalloul@uth.tmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2022 | Feb 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Sham QL | Drug | 20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia |
|
| Sham Local | Drug | 20 mls of normal saline given at incision site |
|
| QL | Drug | QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia |
|
The QOR-40 questionnaire has 40 questions with a total score from 40 (poorest quality of recovery) to 200 (best quality of recovery), with a higher score indicating a better outcome
| 24 hours after anesthesia |
0 corresponding to no pain at all and 10 corresponding to worst imaginable pain
| At the time of first opiate administration(upto one day after surgery) |
| Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | At the time of discharge (upto 3 days after surgery) |
| Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Day 1 (24+/=4 hours post surgery) |
| Pain at Dynamic as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Day 1 (24+/=4 hours post surgery) |
| Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Day 14 post surgery |
| Pain at Dynamic as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Day 14 post surgery |
| Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | 6 weeks post surgery |
| Pain at Dynamic as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | 6 weeks post surgery |
| Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | in PACU(upto 8 hours after surgery) |
| Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 24 hours after surgery |
| Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 2 weeks post surgery |
| Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | 6 weeks post surgery |
| Time to Administration of First Pain Medication in PACU | From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes) |
| Number of Participants With Complications Related to a Study Intervention | 30 days |
| Postoperative Nausea and Vomiting (PONV) Score Before Discharge | Postoperative Nausea and Vomiting (PONV) score before discharge Scale: (none, mild, moderate) | about 24 hours |
| Time Needed to Administer the Intervention QL Block | Time to administration of intervention QL block |
| about 3 hours |
| Number of Participants That Were Discharge on the Same Day | Hospital discharge (up to 24 hours) |
| Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes | about 3 hours |
| Number of Participants With Intraoperative Complications | Intraoperative (about 3 hours) |
| BG001 | QL Block | Sham Local: 20 mls of normal saline given at incision site QL: QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Median | Inter-Quartile Range | kg/m^2 |
|
| Number of Participants who are Nulliparous | Count of Participants | Participants |
|
| Indication for the surgery | Count of Participants | Participants |
|
| History of Previous Uterine Surgery | History of previous uterine Surgery, such as myomectomy or cesarean sections | Count of Participants | Participants |
|
| American Society of Anesthesiology (ASA) Classification | ASA Physical Status Classification System - The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA I :A normal healthy patient ASA II :A patient with mild systemic disease ASA III: A patient with severe systemic disease ASA IV: A patient with severe systemic disease that is a constant threat to life ASA V: A moribund patient who is not expected to survive without the operation ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
|
| Surgery Type | Count of Participants | Participants |
|
| OG001 | QL Block | Sham Local: 20 mls of normal saline given at incision site QL: QL block involves injection of 19 ml of 0.25% Bupivacaine and iml(4mg) of Decadron in a fascial place formed partly by the posterior surface of the quadratus lumborum muscle.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia |
|
|
| Primary | Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 12 questions assessing physical comfort with a maximum score of 60 and a minimum score of 12, a lower score indicating a worst outcome. | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours after anesthesia |
|
|
|
| Primary | Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 5 questions assessing physical independence, with a maximum score of 25 and a minimum score of 5, with a lower score indicating a worst outcome. | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours after anesthesia |
|
|
|
| Primary | Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 7 questions assessing Psychological support, with a maximum score of 35 and a minimum score of 7, with a lower score indicating a worst outcome. | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours after anesthesia |
|
|
|
| Primary | Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 9 questions assessing emotional state, with a maximum score of 45 and a minimum score of 9, with a lower number indicating a worst outcome. | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours after anesthesia |
|
|
|
| Primary | Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire | The QOR-40 questionnaire has 40 questions with a total score from 40 (poorest quality of recovery) to 200 (best quality of recovery), with a higher score indicating a better outcome | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | 24 hours after anesthesia |
|
|
|
| Secondary | Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 3 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | Post anesthesia care unit (PACU) immediately postoperatively |
|
|
|
| Secondary | Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 3 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | At the time of first opiate administration(upto one day after surgery) |
|
|
|
| Secondary | Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data was not collected for 7 participants in the Local Anesthesia at incision site arm. Data was not collected for 9 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | At the time of discharge (upto 3 days after surgery) |
|
|
|
| Secondary | Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (24+/=4 hours post surgery) |
|
|
|
| Secondary | Pain at Dynamic as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data was not collected for 1 participant in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | Day 1 (24+/=4 hours post surgery) |
|
|
|
| Secondary | Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data was not collected for 2 participants in the Local Anesthesia at incision site arm. Data was not collected for 7 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | Day 14 post surgery |
|
|
|
| Secondary | Pain at Dynamic as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data was not collected for 2 participants in the Local Anesthesia at incision site arm. Data was not collected for 7 participants in the QL block arm. | Posted | Mean | Standard Deviation | score on a scale | Day 14 post surgery |
|
|
|
| Secondary | Pain at Rest as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data were not collected for 9 participants in the Local Anesthesia at incision site arm. Data were not collected for 4 participants in the QL Block arm. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post surgery |
|
|
|
| Secondary | Pain at Dynamic as Assessed by the Visual Analog Scale | 0 corresponding to no pain at all and 10 corresponding to worst imaginable pain | Data were not collected for 9 participants in the Local Anesthesia at incision site arm. Data were not collected for 4 participants in the QL Block arm. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks post surgery |
|
|
|
| Secondary | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 4 participants in the QL block arm. | Posted | Mean | Standard Deviation | milligrams | in PACU(upto 8 hours after surgery) |
|
|
|
| Secondary | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 5 participants in the QL block arm. | Posted | Mean | Standard Deviation | milligrams | 24 hours after surgery |
|
|
|
| Secondary | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | milligrams | 2 weeks post surgery |
|
|
|
| Secondary | Amount of Oral Morphine Consumed Measured in Morphine Milliequivalents (OME) | Data was not collected for 3 participants in the Local Anesthesia at incision site arm. Data was not collected for 6 participants in the QL block arm. | Posted | Mean | Standard Deviation | milligrams | 6 weeks post surgery |
|
|
|
| Secondary | Time to Administration of First Pain Medication in PACU | Data were not collected for 1 participant in the QL block | Posted | Mean | Standard Deviation | minutes | From entry to Post anesthesia care unit (PACU) to time to administration of first pain medication in PACU (about 75 minutes) |
|
|
|
| Secondary | Number of Participants With Complications Related to a Study Intervention | Data were not collected for 1 participant in the QL block arm. | Posted | Count of Participants | Participants | 30 days |
|
|
|
| Secondary | Postoperative Nausea and Vomiting (PONV) Score Before Discharge | Postoperative Nausea and Vomiting (PONV) score before discharge Scale: (none, mild, moderate) | Data were not collected for 3 participants in the QL block arm. | Posted | Count of Participants | Participants | about 24 hours |
|
|
|
| Secondary | Time Needed to Administer the Intervention QL Block | Data were not collected for this outcome measure | Posted | Time to administration of intervention QL block |
|
|
| Other Pre-specified | Number of Participants That Required Morcellation | Posted | Count of Participants | Participants | Intraoperative (about 3 hours) |
|
|
|
| Other Pre-specified | Specimen Weight | Posted | Mean | Standard Deviation | grams | inoperative (about 3 hours) |
|
|
|
| Other Pre-specified | Duration of Surgery | Posted | Mean | Standard Deviation | minutes | about 3 hours |
|
|
|
| Other Pre-specified | Number of Participants That Were Discharge on the Same Day | Posted | Count of Participants | Participants | Hospital discharge (up to 24 hours) |
|
|
|
| Other Pre-specified | Number of Participants for Which Lysis of Adhesions Took Greater Than 30 Minutes | Posted | Count of Participants | Participants | about 3 hours |
|
|
|
| Other Pre-specified | Number of Participants With Intraoperative Complications | Posted | Count of Participants | Participants | Intraoperative (about 3 hours) |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 12 |
| 38 |
| EG001 | Local Anesthesia at Incision Site | Local anesthesia at incision site: 20 ml of 0.25% Bupivacaine will be given at incision site Sham QL: 20 mls of normal saline given at QL.The QL block will be administered on both the right and left sides. The transducer is placed transverse immediately cranial to the iliac crest and at the level of the posterior axillary line. The needle is then inserted inplane from the lateral edge of the transducer and advanced through the quadratus lumborum (QL) muscle until the needle tip penetrated the epimysium of the anterior part of the QL muscle. The anesthetic is injected after repeated negative aspiration tests for blood in the fascial interspace between the QL and psoas major (PM) muscles posterior to the transversalis fascia | 0 | 38 | 0 | 38 | 14 | 38 |
| Cuff Cellulitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment |
|
Not provided
Not provided
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Moderate |
|
| Vaginal extraction site |
|