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: Recruiting
• 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 (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Nicholas Schott; Phone Number: 7168807034; Email: schottnj@upmc.edu
• Study Contact Backup: Name: Stephanie Nam; Email: nams@upmc.edu

Study Locations

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

Participation Criteria

Eligibility Criteria

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

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
VAS pain score with movement	Post-operative pain accompanied with patient movement will be measured using a 10 point pain scale (VAS)	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	12, 24 and 36 hours post-operatively
VAS pain score at rest	VAS pain score reported by the patient at rest post-operatively using a 10 point pain scale (VAS)	At baseline (PACU entry) and 1, 4, 24 and 48 hours after intervention
First request for pain medication	Time to first request for as desired (PRN) oral or parenteral opioid medication will be assessed	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	From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours
Pruritis	Presence or absence will be noted	From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours
Nausea	Presence or absence will be noted	From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours
Emesis	Presence or absence will be noted	From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours
Heart Rate	Will be measured in beats/minute (BPM) per standard of care and documented by study staff	From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours
Anesthetic toxicity	symptoms indicating this event such as perioral numbness, ringing in the ears or metallic taste in the mouth will be noted	15 min, 30 min, 45 min, 1 hour, and 4 hours post-operatively
Blood pressure	Will be measured in mmHG per standard of care and documented by study staff	From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours
Respiratory Rate	Will be measured in rate/min per standard of care and documented by study staff	From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours
Oxygen Saturation	Will be measured in % per standard of care and documented by study staff	From post-operative every 24 hours until the patient is either withdrawn from or completes the study, on average 72 hours
36-Item Short Form Survey (SF-36)	Quality of life measures will be assessed using the SF-36	48-hours post-operatively
Brief Pain Inventory (BPI) - Short Form	Severity of pain and its impact on functioning using BPI Short Form	6-weeks post operatively
Edinburgh Postnatal Depression Scale (EPDS)	Possible symptoms of depression in the postnatal period will be assessed via EPDS	6-weeks post operatively
Dynamic Pain Visual Analogue scale	Pain score reported by the patient at rest using the VAS scale	6-weeks postoperatively
Opioid use	Total opioid consumption post-operative	From post-operative until 36 hours and at 6-weeks postoperatively or until the patient is discharged or withdrawn from study

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 (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 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): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 2, 2022
• Last Verified: June 1, 2022

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