Trial Outcomes & Findings for The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy (NCT NCT05480111)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

76 participants

Primary outcome timeframe

24 hours after anesthesia

Results posted on

2024-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	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	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
Overall Study STARTED	38	38
Overall Study Follow up at 24 Hours	32	37
Overall Study Follow up at 6 Weeks	29	34
Overall Study COMPLETED	29	34
Overall Study NOT COMPLETED	9	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Role of Quadratus Lumborum Blocks Following Minimally Invasive Hysterectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Local Anesthesia at Incision Site n=38 Participants 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	QL Block n=38 Participants 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	Total n=76 Participants Total of all reporting groups
Age, Continuous	44 years n=5 Participants	45 years n=7 Participants	44 years n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	38 Participants n=7 Participants	76 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized White	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Other/Unknown/Not Reported	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	38 participants n=7 Participants	76 participants n=5 Participants
Body Mass Index	30 kg/m^2 n=5 Participants	35 kg/m^2 n=7 Participants	32.8 kg/m^2 n=5 Participants
Number of Participants who are Nulliparous	10 Participants n=5 Participants	8 Participants n=7 Participants	18 Participants n=5 Participants
Indication for the surgery Symptomatic fibroids	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Indication for the surgery Other (adenomyosis, polys, abnormal bleeding)	13 Participants n=5 Participants	16 Participants n=7 Participants	29 Participants n=5 Participants
History of Previous Uterine Surgery	29 Participants n=5 Participants	33 Participants n=7 Participants	62 Participants n=5 Participants
American Society of Anesthesiology (ASA) Classification ASA I :A normal healthy patient	21 Participants n=5 Participants	21 Participants n=7 Participants	42 Participants n=5 Participants
American Society of Anesthesiology (ASA) Classification ASA II :A patient with mild systemic disease	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
American Society of Anesthesiology (ASA) Classification ASA III: A patient with severe systemic disease	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
American Society of Anesthesiology (ASA) Classification ASA IV: A patient with severe systemic disease that is a constant threat to life	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
American Society of Anesthesiology (ASA) Classification ASA V: A moribund patient who is not expected to survive without the operation	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
American Society of Anesthesiology (ASA) Classification ASA VI: A declared brain-dead patient whose organs are being removed for donor purposes	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Surgery Type Robotic	34 Participants n=5 Participants	34 Participants n=7 Participants	68 Participants n=5 Participants
Surgery Type Laparoscopic	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Surgery Type Conversion to Open	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours after anesthesia

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Local Anesthesia at Incision Site n=37 Participants 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	QL Block n=32 Participants 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
Pain as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	30.0 score on a scale Standard Deviation 2.8	31.1 score on a scale Standard Deviation 2.2

PRIMARY outcome

Timeframe: 24 hours after anesthesia

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Local Anesthesia at Incision Site n=37 Participants 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	QL Block n=32 Participants 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
Physical Comfort as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	52.9 score on a scale Standard Deviation 4.9	54.3 score on a scale Standard Deviation 5.1

PRIMARY outcome

Timeframe: 24 hours after anesthesia

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Local Anesthesia at Incision Site n=37 Participants 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	QL Block n=32 Participants 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
Physical Independence as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	20.4 score on a scale Standard Deviation 3.0	21.3 score on a scale Standard Deviation 2.4

PRIMARY outcome

Timeframe: 24 hours after anesthesia

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Local Anesthesia at Incision Site n=37 Participants 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	QL Block n=32 Participants 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
Psychological Support as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	30.2 score on a scale Standard Deviation 2.8	30.3 score on a scale Standard Deviation 1.7

PRIMARY outcome

Timeframe: 24 hours after anesthesia

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Local Anesthesia at Incision Site n=37 Participants 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	QL Block n=32 Participants 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
Emotional State as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	42.2 score on a scale Standard Deviation 2.7	42.1 score on a scale Standard Deviation 4.0

PRIMARY outcome

Timeframe: 24 hours after anesthesia

Population: 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.

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

Outcome measures

Outcome measures
Measure	Local Anesthesia at Incision Site n=37 Participants 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	QL Block n=32 Participants 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
Quality of Recovery as Assessed by the Quality of Recovery (QOR-40) Validated Questionnaire	175.6 score on a scale Standard Deviation 9.7	179.1 score on a scale Standard Deviation 10.3

SECONDARY outcome

Timeframe: Post anesthesia care unit (PACU) immediately postoperatively

Population: 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.