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

Sponsor

Nicholas Schott (Other)

Overall Status

Recruiting

CT.gov ID

NCT03261193

Collaborator

(none)

Enrollment

Location

Arms

63.8

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Drug: ITM + Sham QLB Drug: ITM + Bupivacaine QLB	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

QL Block for Post-cesarean Delivery Pain

Actual Study Start Date :

Sep 5, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

VAS pain score with movement [24 hours after surgical procedure (cesarean delivery)]
Post-operative pain accompanied with patient movement will be measured using a 10 point pain scale (VAS)

Secondary Outcome Measures

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First request for pain medication [From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours]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Sedation [From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours]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Pruritis [From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours]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Nausea [From post-operative until the patient is either withdrawn from study or experiences this event up until 72 hours]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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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