NCT03827291

QL Block With Exparel in Colectomy

Completed Phase 4 Results posted Last updated 16 October 2025

What this trial tests

Phase 4 trial testing Exparel in Laparotomy in 35 participants. Completed in 9 December 2022.

Timeline

31 October 2019

Primary endpoint
2 December 2022

9 December 2022

Quick facts

Lead sponsor	Duke University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	31 October 2019
Primary completion	2 December 2022
Estimated completion	9 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Exparel — full drug profile →
• Thoracic epidural analgesia — full drug profile →

Conditions studied

• Laparotomy — all drugs for Laparotomy →
• Colectomy — all drugs for Colectomy →

Sponsor

Duke University

Who can join

Adults 18 to 85, any sex, with Laparotomy or Colectomy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Cumulative Opioid Consumption Over 48 Hours Primary · From arrival to PACU to 48 hours post-operatively

Measured in morphine milligram equivalents.

Group	Value	95% CI
Quadratus Lumborum Block	33	8 – 76
Thoracic Epidural Analgesia	61	40 – 85

Pain While Coughing as Measured by 11-point Numeric Rating Scale (NRS-11) Secondary · 30 minutes after arrival to Post-Anesthesia Care Unit (PACU), and at 8 hours, 24 hours, 36 hours, 48 hours, 72 hours, 96 hours, 120 hours, 144 hours and 168 hours post Exparel administration

The NRS-11 is an 11-point scale where 10=worst pain imaginable and 0= no pain.

30 minutes

Group	Value	95% CI
Quadratus Lumborum Block	5	3 – 7
Thoracic Epidural Analgesia	4	0 – 7

8 hours

Group	Value	95% CI
Quadratus Lumborum Block	3	2 – 6
Thoracic Epidural Analgesia	0	0 – 3

24 hours

Group	Value	95% CI
Quadratus Lumborum Block	3	2 – 4
Thoracic Epidural Analgesia	2	0 – 4

36 hours

Group	Value	95% CI
Quadratus Lumborum Block	2	0 – 4
Thoracic Epidural Analgesia	2	0 – 4

48 hours

Group	Value	95% CI
Quadratus Lumborum Block	4	2 – 5
Thoracic Epidural Analgesia	3	0 – 7

72 hours

Group	Value	95% CI
Quadratus Lumborum Block	2	1 – 5
Thoracic Epidural Analgesia	3	0 – 6

96 hours

Group	Value	95% CI
Quadratus Lumborum Block	2	0 – 5
Thoracic Epidural Analgesia	5	3 – 6

120 hours

Group	Value	95% CI
Quadratus Lumborum Block	2	1 – 5
Thoracic Epidural Analgesia	5	2 – 5

Number of Participants With Block Success Secondary · 30 minutes after arrival to PACU, 8 hours, 24 hours, 36 hours, 48 hours and 72 hours post Exparel administration

Presence of demonstrable sensory block over 4 points on the abdomen (one in each of the 4 quadrants), as tested by response to pinprick. Subjects will be asked to report whether the stimulus feels "sharp" or "dull", indicating block failure and success respectively.

Group	Value	95% CI
Quadratus Lumborum Block	7
Thoracic Epidural Analgesia	1

Number of Participants With Adverse Events Related to the Block Secondary · From administration of Exparel through 168 hours post Exparel administration

Subjects will be evaluated for potential adverse events related to the block including evidence of hematoma, infection, unexpected sensory or motor deficit, local anesthetic systemic toxicity, as well as transient weakness of the hip flexor muscles (a known possible side-effect of QL block).

Group	Value	95% CI
Quadratus Lumborum Block	6
Thoracic Epidural Analgesia	8

Satisfaction With Postoperative Pain Control Secondary · Up to 48 hours post Exparel administration

Overall subject satisfaction with pain control will be recorded on an 11-point scale: 10=highly satisfied, 0=completely unsatisfied.

Group	Value	95% CI
Quadratus Lumborum Block	8	3 – 9

Hospital Length of Stay Secondary · From administration of Exparel through hospital discharge

Measured both by raw length of stay and by time to achieving "discharge readiness", defined by the presence of 3 criteria: a pain score of 3 or less with ambulation, no opioids required in the preceding 6 hours, and the ability to perform self-care (go to the toilet, dress, and shower).

Group	Value	95% CI
Quadratus Lumborum Block	27	24 – 46
Thoracic Epidural Analgesia	55	52 – 97

Number of Participants With Opioid-related Adverse Events Secondary · From administration of Exparel through 168 hours post Exparel administration

Adverse events include nausea, vomiting, ileus, constipation, orthostasis, pruritis, urinary retention, respiratory depression.

Group	Value	95% CI
Quadratus Lumborum Block	10
Thoracic Epidural Analgesia	19

Time to First Mobilization Secondary · From time of arrival in PACU through first mobilization

Group	Value	95% CI
Quadratus Lumborum Block	15	8 – 19
Thoracic Epidural Analgesia	31	27 – 49

Sleep Quality as Measured by Two Questions Secondary · Up to 168 hours post Exparel administration

Each question has a scale of 0 (no interference) to 10 (completely interferes) and the two scores are averaged: "How much did pain interfere with falling asleep?", "How much did pain interfere with staying asleep?"

Group	Value	95% CI
Quadratus Lumborum Block	4	2 – 8

Adverse events — posted to ClinicalTrials.gov

Time frame: From arrival to PACU to postoperative day 7. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Quadratus Lumborum Block

Serious: 1/30 (3%)

Deaths: 0/30

Thoracic Epidural Analgesia

Serious: 0/30 (0%)

Deaths: 0/30

Serious adverse events (1 terms)

Reaction	System	Quadratus Lumborum Block	Thoracic Epidural Analgesia
Extended hospital stay due to left lower extremity numbness	Nervous system disorders	—	—

Other adverse events (11 terms — click to expand)

Reaction	System	Quadratus Lumborum Block	Thoracic Epidural Analgesia
Nausea	Gastrointestinal disorders	—	—
Hypotension	Cardiac disorders	—	—
Orthostasis	Cardiac disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Pruritis	Nervous system disorders	—	—
Unexpected sensory deficit	Nervous system disorders	—	—
Urinary retention	Renal and urinary disorders	—	—
Hip flexor weakness	Nervous system disorders	—	—
Ileus	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Respiratory depression	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Extended hospital stay due to left lower extremity numbness.

Data from ClinicalTrials.gov NCT03827291 adverse events section.

Sponsor's own description

The purpose of this study is to determine if using a different type of injection of local anesthestic (pain medicine) in between the muscle layers of the abdominal wall (called a quadratus lumborum block) will improve pain control and be easier to manage after surgery than the current standard of care epidural (spinal injection) pain relief for patients undergoing laparoscopy colectomy.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.