ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain (qlcsection)

QL Block for Post-cesarean Delivery Pain

Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.

Study Overview

• Status: Terminated
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: ITM + Sham QLB; Drug: ITM + Bupivacaine QLB

Detailed Description

The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.

Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).

Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.

For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.

The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).

The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee Women's Hospital of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective cesarean planned under spinal anesthesia
• Singleton pregnancy
• American Society of Anesthesiologists (ASA) classification score of 2 (or less)
• Gestational age of at least 37 weeks
• Intention to breastfeed infant

Exclusion Criteria:

• Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry)
• Anatomical abnormalities contraindicating spinal or QLB placement
• Received/Conversion to general anesthesia
• Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure)
• History of chronic pain
• History of chronic opioid use/abuse
• History of Subutex, methadone, other maintenance therapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: ITM + Sham QLB; Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.	Drug: ITM + Sham QLB; Sham subcutaneous non-anesthetic infiltration with saline; Other Names: Saline
Experimental: ITM + Bupivacaine QLB; Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.	Drug: ITM + Bupivacaine QLB; QL plane block with local anesthesia; Other Names: Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale (VAS) Pain Score With Movement	Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.	24 hours after surgical procedure (cesarean delivery)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast Feeding Success/Quality	Limited breastfeeding resulting from pain or opioid side effects	24-hours post-operatively
Visual Analogue Scale (VAS) Pain Score at Rest	VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.	1 hour after intervention
First Request for Pain Medication	Time to first opioid dose (measured in hours)	From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours
Sedation	Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.	24-hours post-operative
Pruritis	Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching	4-hours post-operative
Nausea/Vomiting	Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment	4-hours post-operative
Systolic Blood Pressure	Will be measured in mmHG per standard of care and documented by study staff.	4-hours post-operative
Respiratory Rate	Will be measured in rate/min per standard of care and documented by study staff	4-hours post-operative
Oxygen Saturation	Will be measured in % per standard of care and documented by study staff	4-hours post-operative
Visual Analogue Scale (VAS) Pain Score at Rest	VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.	4 hours after intervention
Visual Analogue Scale (VAS) Pain Score at Rest	VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.	24 hours after intervention
Visual Analogue Scale (VAS) Pain Score at Rest	VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.	48 hours after intervention
Pruritis	Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching	24-hours post-operative
Pruritis	Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching	48-hours post-operative
Nausea/Vomiting	Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment	24-hours post-operative
Nausea/Vomiting	Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment	48-hours post-operative
Heart Rate	Standard heart rate obtained	4-hours post-operative
Heart Rate	Standard heart rate obtained	24-hours post-operative
Heart Rate	Standard heart rate obtained	48-hours post-operative
Systolic Blood Pressure	Will be measured in mmHG per standard of care and documented by study staff.	24-hours post-operative
Systolic Blood Pressure	Will be measured in mmHG per standard of care and documented by study staff.	48-hours post-operative
Diastolic Blood Pressure	Will be measured in mmHG per standard of care and documented by study staff.	4-hours post-operative
Diastolic Blood Pressure	Will be measured in mmHG per standard of care and documented by study staff.	24-hours post-operative
Diastolic Blood Pressure	Will be measured in mmHG per standard of care and documented by study staff.	48-hours post-operative
Respiratory Rate	Will be measured in rate/min per standard of care and documented by study staff	24-hours post-operative
Respiratory Rate	Will be measured in rate/min per standard of care and documented by study staff	48-hours post-operative

Collaborators and Investigators

• Sponsor: Nicholas Schott
• Investigators: Study Director: Amy Monroe, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2017
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): November 11, 2022

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 22, 2017
• First Posted (Actual): August 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 6, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: nerve block; analgesia; quadratus lumborum block; post-operative pain; cesarean section pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: PRO16120234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No